• What causes the disorders?
  • Why do certain people get them?
  • How do we best treat the conditions?
  • How do we prevent the disorders?
  • How do we cure them?

Sound medical research is needed to explore these questions.

Here we report a sampling of research studies and medical news that provide clues to better understanding GI disorders. Each new advance adds a small piece to the puzzle, making the big picture clearer.

To learn more about medical research, go to our webpage at Research.

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Medical News Reported at the 2016 ACG Meeting

November 29, 2016 – The following are a selection of research studies presented as abstracts at the 2016 American College of Gastroenterology (ACG) meeting, an annual conference for medical professionals.

The data and conclusions presented here should be considered preliminary until published in a peer-reviewed journal.

Chronic Constipation and Irritable Bowel Syndrome (IBS)

  • In two randomized, double-blind, controlled Phase 3 clinical trials two different doses (3 mg and 6 mg) of the drug plecanatide compared with placebo were found to increase complete spontaneous bowel movements and improve stool consistency, bloating, and straining in 2,683 patients with chronic idiopathic constipation (CIC) over a study period of 12 weeks. Improvements were maintained throughout the treatment period. The drug was well tolerated, with diarrhea (7.1%) and urinary tract infection (2.2%) being the most common adverse effects. While not currently approved in the US by the Food and Drug Administration (FDA), plecanatide is currently under review for CIC and IBS with constipation (IBS-C).

Opioid-Induced Constipation (OIC)

  • Two Phase 3 clinical trials involving over 1,000 individuals with opioid-induced constipation (OIC) found the drug naldemedine compared with placebo to increase the number of spontaneous bowel movements within 4–24 hours of initial dose in OIC patients with chronic non-cancer pain over a study period of 12 weeks. Gastrointestinal (GI) symptoms were the most frequently reported adverse events.

Eosinophilic Esophagitis (EoE)

  • Findings of a ten year retrospective study of 59 adult patients with eosinophilic esophagitis (EoE) suggest that most patients experience a resolution of symptoms and minimal disease impact on quality of life a decade after first diagnosis. Reduced EoE-related quality of life was trivial to minimal in 57% of patients, mild in 18%, moderate in 16%, and severe in 9%. After 10 years, 31% were not on EoE therapy, 63.8% were taking proton pump inhibitors (PPIs), and 6.8% were taking steroids.

C. difficile Infection

  • A nationwide retrospective study of 38,409 patients admitted to the hospital with Clostridium difficile (C. difficile) infection in 2013 found that one in five patients were readmitted within 30 days. Risk factors for readmission included female sex and initial discharge to home rather than to other healthcare facilities. 


  • While the drug aprepitant (Emend) was not found in a clinical trial to meet the primary study endpoint of improving nausea better than placebo in 126 individuals with gastroparesis, researchers suggest that there is cause to investigate the drug further. Among participants, aprepitant (125 mg daily) was found to result in a greater decline in average daily hours of nausea experienced and was found to improve other measures of symptom severity over a study period of 4 weeks. Aprepitant is currently approved by the FDA for the treatment of nausea in chemotherapy patients and those coming out of surgery.

Diagnostic Gene Studies for Chronic Intestinal Pseudo-Obstruction

November 21, 2016 – Chronic intestinal pseudo-obstruction (CIPO), with or without frequent bladder involvement, is caused primarily by a mutation in a gene transmitted through a dominant mode of inheritance (an affected person having a 50% risk of passing the disorder to each of his or her children). The disorder can also occur due to a new mutation. 

Thus far, the most important gene (ACTG2) discovered with mutations account for 44% of patients with CIPO. Analysis of 111 affected individuals (one from each family) from our studies, combined with those reported in the medical literature, revealed that 49 had a mutation in this gene. 

CIPO can be diagnosed prenatally by lab test analysis of this gene which can also enable future prenatal diagnosis and preimplantation genetic diagnosis.

We are seeking a second gene, and welcome families who wish to participate in this research effort. If interested, please email This email address is being protected from spambots. You need JavaScript enabled to view it. for details. 

Website for more information: www.chginc.org.

Source: Aubrey Milunsky, MD, Center for Human Genetics, Cambridge, MA. Featured in Digestive Health Matters Vol. 25 No. 2.

Current Challenges and Emerging Solutions in Upper GI Disorders: A Brief Report of the 2016 AGA Drug Development Conference

November 16, 2016 – In October 2016, the Center for Diagnostic and Therapeutics (CDT) of the American Gastroenterological Association (AGA) held its first Drug Development Conference. Over a two-day period, researchers, clinicians US Food and Drug Administration (FDA) personnel, representatives of the pharmaceutical industry, and patient advocacy groups convened in Washington, DC to discuss current unmet needs and future strategies in four disorders of the upper gastrointestinal (GI) tract. The four disorders discussed were gastroesphageal reflux disease (GERD), eosinophilic esophagitis (EoE), gastroparesis (GP), and functional dyspepsia (FD). Experts in these various disorders presented information on current and potential therapeutic strategies, issues of clinical trial design, and possible therapeutic endpoints to be adopted in future clinical trials. Panel discussions after each session included representatives from the FDA and the pharmaceutical industry.

The AGA is a professional society representing clinicians and researchers in the broad field of GI and liver disorders within the US. in 2014, the AGA created the Center for Diagnostics and Therapeutics with the mission statement: "To support the development of therapies and diagnostic tests that will enhance human health and improve the lives of patients with digestive disorders."

The meeting focused on 4 disease states in the Upper GI tract: reflux disease that is incompletely responsive to acid inhibition, eosinophilic esophagitis, gastroparesis, and functional dyspepsia. These disorders cause significant suffering worldwide and limited treatment options are available particularly in the US.

The meeting addressed several hurdles in the development of new treatments in these disorders. Issues regarding trial design, disease definition, and outcome measurements were discussed and the regulatory perspective was clearly defined. A series of 4 white papers on each of the disease states will be prepared and published in the gastroenterology literature. We hope this will spur innovation and the development of new treatments for these common conditions.

Source: Nimish B. Vakil, MD, AGAF, University of Wisconsin School of Medicine and Public Health, Madison, WI and Colin W. Howden, MD, AGAF, University of Tennessee Health Science Center, Memphis, TN

AGA 2016 Drug Development Conference: Clinical Endpoints in Upper GI Disorders 

November 10, 2016 – Last month IFFGD took part in the American Gastroenterological Association (AGA) 2016 Drug Development Conference, Clinical Endpoints in Upper GI Disorders. This meeting brought together researchers, clinicians, industry leaders, members of the US Food and Drug Administration (FDA), and patient advocates to communicate what is currently known in the field of upper gastrointestinal (GI) disorders and to provide input into the design and conduct of future clinical trials. Meetings such as this one can help to elevate the research profile of these conditions, share insight into ways to improve research into effective therapies, and, ultimately, improve the lives of all those living with a functional GI or motility disorder.

Swallowed Flonase Effective for Long-Term Management of EoE in Children

October 26, 2016 – A prospective, single-center study of 54 children (80% male) between the ages of 2 and 17 years with active eosinophilic esophagitis (EoE) that looked at long-term safety (up to around 24 months) of swallowed fluticasone (flonase) concluded that swallowed fluticasone is effective as a long-term management therapy for children with EoE, without growth impediment or serious side effects.

Source: Andreae DA, et al. Am J Gastroenterol. August 2016.

An Association, But Not a Clear Link, Has Been Observed Between the Inflammatory Condition, Rosacea, and Certain Gastrointestinal Disorders

October 17, 2016 – A nationwide study in Denmark of 49,475 individuals with rosacea (an inflammatory facial skin condition) and 4,312,213 controls found an association between rosacea and the incidence of certain gastrointestinal disorders, including irritable bowel syndrome (IBS), celiac disease, and Crohn's disease. While no causal link is known, the authors suggest that clinical suspicion of these conditions should be considered in patients with rosacea with gastrointestinal symptoms.

Source: Egeberg A, et al. Brit J Dermatol. August 2016.

Relamorelin Found to Reduce Symptoms in Adults with Diabetic Gastroparesis

September 26, 2016 – In a 4-week randomized, double-blind, Phase 2 clinical study involving 204 adults with diabetic gastroparesis, the drug relamorelin was found to be better than placebo in accelerating gastric emptying and reducing vomiting. No overall safety concerns were identified.

Source: Lembo A, et al. Gastroenterology. July 2016. 

C. difficile Infection May Be a Risk Factor for IBS

September 9, 2016 – Among 205 individuals with Clostridium difficile (C. difficile) infection with no pre-infection history or irritable bowel syndrome (IBS), 25% (n = 52) developed IBS over 6 months following infection. Mixed diarrhea and constipation predominant IBS (IBS-M) was the most common diagnosis, followed by IBS with diarrhea (IBS-D). Longer duration of C. difficile infection (greater than 7 days), high anxiety scores, and higher body mass index (BMI) were found to be independent risk factors for the development of post-infectious IBS.

Source: Wadhwa A, et al. Aliment Pharmacol Therap. July 2016.

New Breath Test for Gastroparesis

September 6, 2016 – A new non-invasive, non-radioactive Gastric Emptying Breath Test (GEBT) approved in 2015 by the US Food and Drug Administration (FDA) has recently become available. The GEBT, conducted over a four-hour period after an overnight fast and a special meal, is designed to show how fast the stomach empties solids by measuring carbon dioxide in a patient's breath. Researchers compared diagnostic results from both GEBT and the conventional gastric scintigraphy test and found that GEBT results agreed with scintigraphy results 73-97 percent of the time when measured at various points during the test. Talk to your doctor in order to determine if either test is suitable for you.

Nausea and Vomiting in Gastroparesis

August 30, 2016 – Among 159 patients with gastroparesis (107 idiopathic) enrolled in the National Institute of Diabetes and Digestive and Kidney Disorders (NIDDK) Gastroparesis Registry asked to complete questionnaires assessing nausea and vomiting in gastroparesis and their influence on quality of life, nausea was found to be present in essentially all patients (96%) with gastroparesis regardless of cause and was found to be associated with decreased quality of life. In contrast, vomiting was found to be more prevalent, more severe, and occurred more frequently in individuals with diabetic gastroparesis. Diabetic patients more often experienced vomiting in the morning before eating, during the night, and when not eating.

These observations suggest that, while nausea was present in nearly all patients regardless of cause, the characteristics of vomiting differ between individuals with diabetic and idiopathic gastroparesis.

Source: Parkman HP, et al. J Neurogastroenterol Motil. June 2016.

Family Environments May Play Roles Equal to Genetics in Some Diseases

July 30, 2016 – Researchers who examined the medical histories of a large group of people and their families from the United Kingdom (UK) – including both blood and adoptive relatives – concluded that family history of disease may be as much the result of shared lifestyle and surroundings as inherited genes.

Looking at incidences of 12 common diseases, the results show that not only genetic and but also familial environmental factors make substantial contributions to a person’s risk of some diseases, pointing out the need to identify environmental factors that contribute to diseases and how to modify them to reduce disease risk.

The researchers used data from self-reported personal and family history of disease in 1,555,906 white European participants and relatives from the UK Biobank database of volunteers’ health.

Primary Source: Munoz M, et al. Nature Genetics July 2016.

Rome IV Released at DDW

July 5, 2016 – This May the Rome Foundation, a nonprofit professional organization, unveiled the fourth edition of their comprehensive diagnostic criteria for functional digestive conditions at Digestive Disease Week (DDW) in San Diego, California. The release of Rome IV – Functional Gastrointestinal Disorders; Disorders of Gut-Brain Interaction – comes almost 10 years after the publication of the third edition of the criteria.

The Rome Foundation has played a pivotal role in creating diagnostic criteria and contributing to the discovery and application of new knowledge in the field of functional gastrointestinal disorders (FGIDs). Rome IV is a collection of the knowledge accumulated since Rome III was published 10 years ago.

It expands upon previous editions in a number of ways, including:

  • Updating the basic and clinical literature
  • Offering new information on gut microenvironment; gut-brain interactions; how genes affect a person's response to drugs (pharmacogenomics); and biopsychosocial, gender, and cross-cultural understandings of FGIDs
  • Reducing the use of imprecise and occasionally stigmatizing terms when possible
  • Using updated diagnostic algorithms
  • Incorporating information on the patient illness experience, and physiological subgroups or biomarkers that might lead to more targeted treatments

Notably, Rome IV adopts a definition for FGIDs that is affirmative and reflective of current scientific knowledge:

Functional GI disorders are disorders of gut-brain interaction. They are a group of disorders classified by GI symptoms related to any combination of the following:

  • motility disturbance,
  • visceral hypersensitivity,
  • altered mucosal and immune function,
  • altered gut microbiota, and
  • altered central nervous system processing

Rome IV lists the 33 adult and 20 pediatric FGIDs, including descriptions of their respective anatomic domains, pathophysiology, diagnostic features, and treatment aspects.

Other diagnostic tools, including supplements for pediatric and primary care practitioners, accompanied the release of Rome IV. Together, these tools will help healthcare professionals in all clinical settings better identify and treat functional GI disorders and ultimately, improve the lives of people living with these conditions.

Source: Drossman DA. Gastroenterology. May 2016.

Medical News Reported at the 2016 DDW Meeting

June 28, 2016 – The following are a selection of research studies presented as abstracts at the 2016 Digestive Disease Week (DDW), an annual international conference for medical professionals.

The data and conclusions presented here should be considered preliminary until published in a peer-reviewed journal.


  • The online community-based survey, developed by IFFGD with the help of gastroenterologists, of 1,423 adult patients with gastroparesis aimed at understanding patients' experiences with gastroparesis reported the following:
    • The average time from symptom onset to a positive diagnosis of gastroparesis was 6.8 years.
    • Patients with gastroparesis have a decreased quality of life (as assessed with SF-36 quality of life measures, particularly the physical health component).
    • When gastroparesis symptoms became severe, troubling symptoms included nausea (52%), stomach pain (46%), vomiting (30%), and bloating (25%).
    • Many patients expect their health to get worse over time as a result of their gastroparesis (47%).
    • A majority of patients reported that they are not satisfied with the current treatment options available (64%) and many want specific treatments for gastroparesis (48%).
    • A large number of patients find out about treatments not only from their physician but also using the Internet, including social media.
  • Another study of the IFFGD survey data looked at determining what specific symptoms contribute to the impaired quality of life in community patients with gastroparesis. Focusing treatments on nausea, vomiting, early fullness (satiety), and upper abdominal pain in patients with gastroparesis may improve quality of life.
  • A survey of 173 patients with gastroparesis concluded that poor quality of life is consistently present in the condition. Other factors in addition to symptoms of gastroparesis that contributed to poor quality of life included symptoms of irritable bowel syndrome (IBS) and gastroesophageal reflux disease (GERD); psychological factors of anxiety and depression; patient-related factors such as weight, smoking, and drinking; unknown cause; and sudden onset of symptoms.
  • Among 33 patients with gastroparesis resistant to medical treatment who underwent Enterra II gastric electric stimulation (GES) therapy surgical placement, roughly two-thirds (22) reported improvement in symptoms, including nausea, abdominal pain, stomach fullness, loss of appetite, vomiting, and bloating.

All Functional Digestive Disorders (FDD)

  • Looking at patient data from the Nationwide Inpatient Sample (NIS) in the US between 1993 and 2013, researchers found that hospitalizations for functional digestive disorders increased from 24,544 to 197,660 per year and that the average cost per discharge increased from $6,445 to $24,094 despite a relatively stable length of stay. Most of these patients were admitted from emergency departments (ED). Constipation and abdominal pain were the most common FDD discharge diagnoses. Abdominal pain and IBS discharges were the most frequent discharges in the 18-44 year age group. IBS was more common in females. Gastroparesis and dyspepsia were most common in the 45-64 year age group, while constipation discharges were most frequent in the 65-84 year age group.

Chronic Idiopathic/Functional Constipation (CIC)

  • A study in 25 children with constipation resistant to medical treatment aimed to determine the long-term effectiveness and benefit of sacral nerve stimulation (SNS) therapy found that SNS showed promise over a period of 2 years. The majority of parents of children treated with SNS (88%) reported that they were satisfied with the treatment even though SNS treatment carried a 24% complication rate requiring additional surgery. The authors caution that further long-term studies are needed to identify predictors of outcome, particularly risk factors for complications from SNS placement. 
  • Compared with placebo, the drug plecanatide was found to improve stool frequency and stimulate complete spontaneous bowel movements in a clinical trial of 1,337 patients with CIC. The treatment was well tolerated with mild diarrhea being the most common side effect.
  • A review of existing studies supports the use of probiotics compared with placebo in reducing symptoms of chronic constipation in children. However, the evidence base is of moderate quality and relatively small. The authors recommend further research to demonstrate long-term effects of probiotics.


  • In a pilot study of 24 patients with achalasia a relatively new endoscopic procedure for the treatment of achalasia (Per-Oral Endoscopic Myotomy, or POEM) was found to improve achalasia related symptoms and social functioning. Acid reflux was found to be common following the procedure and patients may require long-term acid reducing medication.

Cyclic Vomiting Syndrome (CVS)

  • A study aimed at determining the clinical characteristics of patients hospitalized for CVS reviewed hospital discharge data involving 20,952 patients with CVS and 44,262 patients without CVS confirmed findings from previous studies that CVS is associated with several co-existing conditions, particularly dysautonomia. While the CVS patients tended to have more favorable hospital outcomes compared to non-CVS patients, there was a substantial economic burden associated with hospitalizations in CVS. The researchers concluded that efforts to avoid unnecessary diagnostic testing, optimize outpatient care, and reduce healthcare utilization are warranted.


  • An evaluation of fourteen years of patient posts on a patient-organized online IBS self-help and support group revealed that patients discuss treatment options more often than symptoms and pathophysiology. Prominent posts before 2002 included key words "antidepressant," "cognitive behavior therapy," and "fiber." Keywords "FODMAP" and "gluten-free" reached their highest numbers in 2012 and postings about stress remained high throughout the fourteen years. Looking at how patients discuss IBS can alert physicians to patients' perspectives on their disease and can result in a more effective doctor-patient dialogue and improve symptoms.
  • Overlap between IBS and functional dyspepsia was found to be frequently unrecognized or undocumented in a study of 391 patients in a clinical setting. Patients with unrecognized IBS and functional dyspepsia overlap were found to have more severe symptoms compared with either functional dyspepdia or IBS patients.
  • A study of 530 IBS patients and 337 controls showed a higher number of chronic medical conditions among the immediate families of individuals with IBS. Illness burden in the family was also found to be associated with the IBS patients' own co-morbidities. Of the chronic conditions found among families, migraine, tension headache, back pain, and insomnia were the most frequent.

IBS with Diarrhea (IBS-D)

  • A study of 171 individuals with IBS-D found that those who adhered to a low FODMAP diet experienced improvements in abdominal symptoms, including pain and bloating, compared to a control diet. While stool frequency was also improved on a low FODMAP diet, abdominal symptoms overall showed greater improvement than bowel symptoms. The authors found benefits for bloating were identified within 2 weeks of initiation and conclude their data suggest that a 2-4 week trial with the low FODMAP diet is sufficient to determine clinical response.
  • In another study of the same IBS-D patient population referenced above, a low FODMAP diet compared to a control diet was associated with greater improvement in health-related quality of life, reduced activity impairment, and sleep quality.
  • The drug ramosetron was found to be safe and effective compared to placebo in treating symptoms of IBS-D in both men and women in a review of existing studies. The most frequent side effects of the treatment were hard stools and constipation.

IBS with Constipation (IBS-C)

  • A large population-based online survey of 30,000 people in Japan found that abdominal bloating is the most common and bothersome symptom in patients with IBS-C. Overall, IBS-C patients experienced a high degree of anxiety in their daily lives and considered bowel habit to be an indicator of general health more than controls.

Mirtazapine Found to Reduce Some Symptoms of Functional Dyspepsia

May 27, 2017 – Results of a randomized, double-blind, placebo-controlled pilot study of 34 mostly female (29) patients with functional dyspepsia who have experienced weight loss of greater than 10% of their original body weight found the antidepressant drug mirtazapine to improve symptoms of early feeling of fullness (satiation), quality of life, gastrointestinal-specific anxiety, nutrient tolerance, and unintentional weight loss better than placebo over 8 weeks. The principal side effect of the drug was drowsiness. Further research is necessary to confirm the safety and efficacy of mirtazapine for functional dyspepsia with weight loss.

Source: Tack J, et al. Clin Gastroenterol Hepatol. March 2016.

High Prevalence of Functional GI Disorder Diagnoses in Pediatric Outpatient Clinic

April 25, 2016 – Over half (52%) of 976 pediatric patients admitted to an outpatient pediatric gastroenterology clinic were positively diagnosed with one or more functional gastrointestinal (GI) disorders using Rome III criteria. In patients younger than 4 years, functional constipation (29%), infant regurgitation (13%), and cyclic vomiting syndrome (CVS: 10%) were the most prevalent. In patients ages 4 to 18 years, the most common diagnoses were irritable bowel syndrome (IBS: 36%), abdominal migraine (19%), functional constipation (17%), and CVS (8%).

Source: Rouster AS, et al. J Pediatr Gastroenterol Nutr. October 2015.

Preliminary Results Announced for OIC Treatment

April 18, 2016 – Positive results were reported from a randomized, double-blind, placebo-controlled Phase 3 cinical trial of investigational drug naldemedine in 547 patients with opioid-induced constipation (OIC) following use of opioids for chronic, non-cancer pain. Naldemedine was found to significantly increase spontaneous bowel movements better than placebo over a study period of 12 weeks. The drug was well-tolerated, with diarrhea and abdominal pain being the principal side effects.

Source: American Academy of Pain Medicine (AAPM) 2016 Annual Meeting. Poster #192.

IBS Associated with Vitamin D Deficiency

April 14, 2016 – The authors of a randomized, double-blind pilot study of 51 individuals with irritable bowel syndrome (IBS) found to have low levels of vitamin D suggest that the impact of IBS on quality of life may be heightened by vitamin D deficiency, which is commonly associated with low quality of life. They suggest that individuals with IBS might benefit from screening and possible supplementation.

Source: Tazzyman S, et al. BMJ Open Gastroenterol. November 2015.

Eluxadoline (Viberzi) Effective in the Relief of IBS-D Symptoms

April 8, 2016 –Twice daily eluxadoline was found to improve stool consistency and reduce abdominal pain as well as frequency and urgency of bowel movements better than placebo in a randomized, double-blind study of 2,427 adult men and women with diarrhea predominant irritable bowel syndrome (IBS-D). Sustained efficacy of the drug was demonstrated over a period of 6 months. The most common adverse events were constipation and nausea. Learn more

Source: Lembo AJ, et al. New Engl J Med. January 2016.

Nutrition Research Roadmap Released

March 21, 2016 – Earlier this month the Interagency Committee on Human Nutrition Research (ICHNR) released the first Nutrition Research Roadmap, designed to guide federal nutrition research. The 2016-2021 National Nutrition Research Roadmap aims to encourage focus on research that can promote a more individualized approach to disease prevention and health as well as emphasizes the importance of addressing information gaps in nutrition-related chronic disease and health disparaties research.

Source: US Department of Health and Human Services (HHS)

Patient Experiences of Foods on Gastroparesis Symptoms

March 14, 2016 – A study surveyed 45 individuals with gastroparesis (39 with idiopathic gastroparesis) to identify and characterize foods that may worsen symptoms of gastroparesis as well as foods that may help alleviate symptoms. Foods found to provoke symptoms tended to be fatty, acidic, spicy, and roughage-based, and included orange juice, fried chicken, cabbage, oranges, sausage, pizza, peppers, onions, tomato juice, lettuce, coffee, salsa, broccoli, bacon, and roast beef. Tolerable foods (not symptom provoking) were generally bland, sweet, salty, and starchy, such as ginger ale, gluten-free foods, tea, sweet potatoes, pretzels, white fish, clear soup, salmon, potatoes, white rice, popsicles, and applesauce. Saltine crackers, Jello, and graham crackers were reported to moderately improve symptoms.

Source: Wytiaz V, et al. Dig Dis Sci. April 2015.

Psychological Therapies Found to Reduce Symptoms of IBS

March 1, 2016 – A review of existing randomized controlled research studies, involving data from 2,290 individuals with irritable bowel syndrome (IBS), concluded that psychological therapies, including cognitive, relaxation, and hypnosis treatments, are effective in improving gastrointestinal symptoms in adults with IBS. About half of participants were assigned to a psychotherapy and half to control conditions (such as treatment as usual, education, sham treatments). On average, individuals who received psychotherapy had a greater reduction in GI symptoms after treatment than 75% of individuals assigned to a control condition and effectiveness was maintained after both short-term (less than 6 months) and long-term (6-12 months) follow-up periods.

Source: Laird KT, et al. Clin Gastroenterol Hepatol. December 2015.

Treatment Approved by FDA for Fecal Incontinence

February 18, 2016 – The US Food and Drug Administration (FDA) has approved the surgically implanted FENIX Continence Restoration System to treat fecal incontinence (FI) in certain individuals who are not candidates for, or who have not previously been helped by, medical or other surgical treatment options. The FENIX System consists of a ring of titanium beads with magnetic cores designed to support a weak sphincter muscle with the aim of reducing incontinence events. The FDA reviewed data for the FENIX System through the humanitarian device exemption (HDE) process. The system was studied over a 12 month period in 35 adults who failed conventional medical therapy for treating FI. Among patients who have failed other fecal incontinence therapies, the results suggest that some could benefit from the device. Adverse events identified in the clinical trial for the FENIX System include pain, infection, impaction or defecatory disorder, device erosion, device removal/re-operation, and bleeding. Find more details on this FDA webpage.

National Survey Finds GI Disorders Continue to be Source of Substantial Burden and Cost

February 1, 2016 – A national survey in the US of data on symptoms and diagnoses, hospitalizations, emergency department visits, and mortality of gastrointestinal (GI), liver, and pancreatic diseases from the years 2007 through 2012 found that these conditions remain a source of considerable burden and health care cost. Notable findings include:

  • Nearly 1 million discharge diagnoses of functional GI and motility disorders were made (mostly for constipation) from emergency departments
  • The most common GI symptoms prompting ambulatory visits were abdominal pain (more than 27 million), bleeding (more than 3.6 million), constipation (more than 3 million), and anorectal symptoms (more than 2.5 million)
  • The most common GI diagnoses in the ambulatory setting included abdominal pain (more than 16.6 million), gastroesophageal reflux disease (GERD) and reflux esophagitis (more than 7 million), and constipation (more than 3.7 million)
  • Hospitalizations for C. difficile infection increased by 151% since 2003 with a total cost of more than $1.1 billion

Data for this study were collected from the Centers for Disease Control and Prevention (CDC), the Agency for Healthcare Research and Quality, and the National Cancer Institute.

Source: Peery AF, et al. Gastroenterology. December 2015.

IBS Treatment More Cost Effective in Primary Care Setting

January 27, 2016 – A controlled retrospective study of reimbursement data in the Netherlands of 326 patients with irritable bowel syndrome (IBS) in the primary care setting and 9,274 IBS patients seen by specialists in a secondary care setting between the years 2006 and 2009 concluded that health care costs associated with IBS are significantly greater in secondary care settings. Total health care costs increased by 29% for primary and 116% for secondary care following a diagnosis of IBS and generally remained at these levels for the duration of the study period.

Based on these findings, the authors suggest that IBS should be treated in a primary care setting where possible and referrals to secondary or other specialist care settings should be restricted to patients with alarm or ambiguous symptoms.

Source: Flik CE, et al. BMC Gastroenterol. November 2015.

Transoral Incisionless Fundoplication for GERD

January 21, 2016 – Results of a double-blind, controlled study of 44 patients with moderate to severe gastroesophageal reflux disease (GERD) symptoms resistant to standard proton pump inhibitor (PPI) therapy concluded that the minimally invasive transoral incisionless fundoplication (TIF2) procedure is safe and offered greater relief of symptoms after 6 months compared to the sham intervention. These results suggest that TIF2 may provide an alternative treatment option for certain chronic GERD patients.

Source: Hakansson B, et al. Aliment Pharmacol Ther. October 2015.

NIH Releases Strategic Plan through Year 2020

January 13, 2016 – After hearing from hundreds of stakeholders, the US National Institutes of Health (NIH) has unveileved its strategic plan for fiscal years 2016-2020. The plan outlines specific advances over the next 5 years, including contributing research to promote US Food and Drug Administration (FDA) approval of treatments of rare diseases, as it endeavors to pursue its mission of working to enhance health, lengthen life, and reduce illness and disability.

The NIH, through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), provides the bulk of all federally supported functional gastrointestinal and motility disorders research.

Funding Support for Digestive Conditions Research in the US FY 2016 Budget

January 12, 2016 – On December 18, 2015 President Obama signed the Omnibus Appropriations Bill, which funds federal agencies through Fiscal Year (FY) 2016.

The nation's primary biomedical research agency, the National Institutes of Health (NIH), received a $2 billion increase from FY 2015 – a $1 billion increase over the President's budget request. The National Institute of Diabetes and DIgestive and Kidney Diseases (NIDDK), the branch of the NIH that supports most federally-funded digestive conditions research, will receive a $68 million increase over the FY 2015 funding level.

This represents the highest increase the NIH and its agencies have received in 12 years.

Assessment of Long-Term GES in Children with Gastroparesis

January 4, 2016 – A long-term study of gastric electrical stimulation (GES) in 97 mostly female patients with gastroparesis concluded that the therapy is safe and effective for certain children and adolescents with treatment-resistant gastroparesis who experienced improvement with GES in their symptoms for at least a full year.

Source: Islam S, et al. J Pediatr Surg. October 2015.

IBS Associated with Erectile Dysfunction

December 21, 2015 – Incidence of erectile dysfunction (both of physiologic and psychologic origins) was found to be considerably higher among the 15,533 male individuals with irritable bowel syndrome (IBS) surveyed from the Taiwan National Health Insurance Program compared with 62,124 healthy controls. Other factors associated with an increased risk of erectile dysfunction included increasing age, higher income, living in urban areas, and co-existing kidney disease, diabetes, hyperlipidemia, and the use of antihypertensive drugs, antidepressants, and benzodiazepines.

Source: Hsu CY, et al. Int J Impt Res. October 2015.

Reflux Symptoms Not Always GERD

December 14, 2015 – A study of 106 individuals with typical reflux symptoms persisting despite treatment with proton pump inhibitors (PPIs), which limit acid secretion in the stomach, aimed to determine the underlying cause of reflux symptoms not responding to PPI therapy. The study found that approximately one-third of the patients suffer from disorders other than gastroesophageal reflux disease (GERD), predominantly functional heartburn, concluding that this explains, at least partly, why many patients will not benefit from acid inhibitory treatment.

Source: Herregods TVK, et al. Neurogastroenterol Motil. September 2015.

Ramosetron Found to Reduce Symptoms of IBS-D in Women

December 4, 2015 – Ramosetron was demonstrated to reduce symptoms of abdominal pain and discomfort and improve stool consistency and quality of life better than placebo in a randomized, double-blind study of 576 female patients with diarrhea predominant irritable bowel syndrome (IBS-D) in Japan over a period of 12 weeks. While ramosetron is approved for the treatment of IBS-D in men in Japan, this demonstrates its efficacy in treating IBS-D in women. Constipation was the most common adverse effect of the drug.

Source: Fukudo S, et al. Gastroenterology. November 2015.

Prescription Drug Use on the Rise in the US

December 1, 2015 – A survey of prescription drug use in the United States between 1999 and 2012 among 37,959 adult individuals revealed an increase in overall use as well as an increase in the simultaneous use of 5 or more prescription drugs even after accounting for changes in the age distribution of the study population. Drug classes that saw the greatest increases in use included antihyperlipidemic agents, antidepressants, prescription proton-pump inhibitors (PPIs), and muscle relaxants.

Source: Kantor ED, et al. JAMA. November 2015.

Hypnotherapy for Esophageal Disorders

November 24, 2015 – A published article reviewed the use of esophageal-directed hypnotherapy for the treatment of dyspepsia, globus sensation (lump in the throat), heartburn, non-cardiac chest pain, and dysphagia (difficulty swallowing) in patients where other therapies have been inadequate. In constructing a treatment plan for patients who will likely benefit from the hypnotherapy, researchers at Northwestern University have utilized structured, scripted protocols for most of these conditions. The authors conclude that in addition to an initial medical workup, hypnotherapy to manage disorders of the esophagus appears to be a viable consideration for the treatment of appropriate candidates.

Source: Riehl ME, et al. Am J Clin Hypn. June 2015.

Survey Finds that Patients Lack Access to Digital Health Tools

November 17, 2015 – A survey of more than 5,000 adult Americans revealed that most are unaware of or don't have access to technology that could be used to communicate with their physician and health care team for better quality healthcare. Among the key findings of the survey were that just 14% have round-the-clock access to medical advice, 15% use email to communicate with their provider, only 1 in 5 have access to online appointment scheduling, and less than half of individuals polled receive even the traditional telephone appointment reminder.

Source: Council of Accountable Physician Practices (CAPP) and the Bipartisan Policy Center (BPC). November 2015.

Hypnosis Therapy for GERD

June 25, 2015 – A pilot study of 9 mostly female patients with functional heartburn found that esophageal directed hypnotherapy performed weekly over seven weeks was associated with improvement in heartburn symptoms and quality of life, suggesting the use of hypnotherapy in functional heartuburn patients who do not respond to standard drug therapies or who would prefer a non-pharmacologic lifestyle intervention.

Source: Riehl ME, et al. Dis Esophagus. 2015 March.

Biomarker Advances for IBS

June 23, 2015 – Two antibodies evident in a blood test appear helpful as biomarkers for differentiating a diagnosis of irritable bowel syndrome (IBS) from inflammatory bowel disease (IBD) in subjects with chronic diarrhea. The antibodies form in people who experience a bout of gastrointestinal (GI) infection (gastroenteritis), and about 10% of these individuals later develop what's termed post-infectious IBS (PI-IBS). It is estimated that 6-17% of people with IBS have PI-IBS.

Source: Pimentel M, et al. PLoS One. 2015 May.

A Medical Food may Improve IBS Symptoms

June 23, 2015 – Researchers in a small study that followed 14 patients with various forms of IBS concluded that oral serum-derived bovine immunoglobulin/protein isolate (SBI) as a medical food provides a safe option for patients with IBS-D but may have application in other forms of IBS. When directly questioned, 12 of the 14 patients indicated some level of overall improvement within 4 weeks after the addition of SBI to their standard therapy.

Source: Good L, et al. World J Gastroenterol. 2015 March.

Medical News Reported at the 2015 DDW Meeting

June 15, 2015 – Following are some of the research studies that were presented as abstracts at the 2015 Digestive Disease Week (DDW), an annual international conference for medical professionals.

The data and conclusions presented here should be considered preliminary until published in a peer-reviewed journal.

C. difficile

  • In a preliminary study of 12 patients with recurrent C. difficile infection, fecal microbial transplantation was found to alter the antibiotic resistant profile of most recipients of the therapy to resemble the profile of the donor, and was maintained over time.

Celiac Disease

  • When analyzed, of 15 different brands of popular probiotics labeled "gluten free," 8 were found to contain gluten, including 2 that contained significant amounts (more than 20 parts per million).
  • A survey of 12,187 patients with celiac disease compared to an equal number of healthy controls found that individuals with celiac disease had a higher prevalence of certain other chronic conditions, including IBS (8% compared to 1%).

Chronic Constipation

  • An analysis of 6 randomized controlled studies demonstrated a consistent safety and efficacy profile for the drug prucalopride in the treatment of chronic constipation over 12 weeks in both men and women.
  • In a randomized controlled study of 314 patients with chronic idiopathic constipation (CIC) with abdominal bloating, linaclotide (Linzess) compared to placebo was found to improve patient confidence in bowel movement success, completeness, ease, and patient ability to predict bowel movement timing.

Eosinophilic Esophagitis (EoE)

  • Oral fluticasone, a steroid, was found to be an effective long-term maintenance therapy of EoE without growth impediment or serious side effects in 54 mostly male children for up to 5.7 years.
  • A randomized controlled study of 93 adolescents and adults with EoE found that treatment with the steroid, oral budesonide suspension, improved symptoms of dysphagia and EoE more effectively than placebo after 12 weeks, with a good safety profile.

Gastroesophageal Reflux Disease (GERD)

  • A 5-year follow-up analysis of 85 patients with GERD treated with the LINX magnetic antireflux device concluded that the device provides significant and durable reflux control with minimal side effects.
  • Results from a random sample of 52 users of proton pump inhibitors (PPIs) compared with 52 controls, all over the age of 50, suggest that long-term (at least 5 continuous years) use of PPIs does not have a significant effect on bone strength.
  • Researchers found a correlation between acid reflux and dental erosion in a sample of 27 children with reflux. By contrast, non-acid reflux was not associated with dental erosion.
  • A survey of 94 patients reporting reflux symptoms, including heartburn, regurgitation, and the sensation of burning/pain in the chest found that about one-third with reflux symptoms resistant to standard therapies do not have GERD, but instead suffer from other disorders, most commonly functional heartburn.


  • In an exploratory study involving 34 patients with gastroparesis, an investigational drug, velusetrag (30 mg), was generally well tolerated and resulted in statistically significant improvement in gastric emptying time in both diabetic and idiopathic gastroparesis.
  • In a study of people with gastroparesis or gastroparesis-like symptoms enrolled in the Gastroparesis Clinical Research Consortium (GpCRC) registry, of 92 treated with gastric electrical stimulation (GES) and 542 not treated with GES, those who underwent GES therapy were significantly more likely to show improvement in gastric symptoms at 48 weeks than those without GES treatment, suggesting more research be done in targeting GES therapy for gastroparesis patients not responding to standard medical approaches.
  • Transcutaneous electrical acupuncture was found to effectively reduce symptoms of nausea and vomiting in 10 female patients with diabetic gastroparesis by altering neural activity.
  • A survey that looked back at hospital admissions in the US for gastroparesis found that between the years 1997 and 2012 the number of inpatient admissions and the costs associated with these admissions have increased dramatically, with the national costs for gastroparesis increasing by 1,116.5%.

Irritable Bowel Syndrome (IBS)

  • In a randomized controlled study of 75 patients with IBS on the low-FODMAP diet, adding gluten avoidance did not appear to offer additional symptom benefits and made it harder for patients to follow the diet.
  • The presence and severity of abdominal bloating in a sample of 472 mostly female patients with IBS was found to be associated with increased sensation (visceral hypersensitivity) to intestinal contents, underscoring the importance of hypersensitivity as a target for treatment in patients with IBS.
  • While dietary advice was found to be effective in reducing gastrointestinal symptoms of IBS in a sample of 67 patients, researchers found no clear difference between a low-FODMAPs diet and traditional IBS dietary advice.
  • A survey of 84 people with IBS and 226 healthy controls found that the IBS patients tend to have more widespread and severe non-gastrointestinal pain on average, most commonly headache (80%) and lower back pain (74%), which may point to a broader pain sensitization, but cannot account for increased levels of abdominal pain characteristic to IBS.

IBS in Children

  • A randomized controlled study of 84 children with IBS found that treatment with psyllium fiber altered gut microbiome composition and reduced pain frequency more effectively than placebo.

IBS with Constipation (IBS-C)

  • In a Phase 2 study of the drug tenapanor (50 mg), statistically significant improvement was seen in multiple symptoms of IBS-C over a 12-week period, with diarrhea the most common adverse effect.

IBS with Diarrhea (IBS-D)

  • In a randomized controlled study of 72 mostly female patients with IBS-D or mixed IBS (IBS-M), a sustained release peppermint oil formulated to target release in the small intestine (IBgard) was found to be statistically more effective than placebo in improving multiple IBS symptoms over a 4-week treatment period.
  • A Phase 3 study of the drug ramosetron concluded that the drug improves multiple symptoms of IBS-D more effectively than placebo in both men and women.

Short Bowel Syndrome

  • A pilot study of 8 patients with short bowel syndrome with intestinal failure and jejunostomy found that treatment with the drug liraglutide may slow intestinal transit and increase intestinal energy absorption.

Small Bowel Adhesions

  • A manually applied physical therapy protocol, focusing on deforming adhesions between and within the organs throughout the abdomen and pelvis, was found to be an effective treatment option in a sample of 26 patients with a history of small bowel adhesions, and was associated with improvement in reported symptoms including pain and overall quality of life.

Nocturnal GERD Linked to Non-Infectious Rhinitis

June 9, 2015 – A prospective 10-year study of 5,417 participants found that nighttime gastroesophageal reflux disease (GERD) appears to be a risk factor for non-infectious rhinitis/rhinosinusitis (NIR) when adjusted for other known risk factors such as age, gender, body mass index, tobacco use, and asthma. NIR is associated with symptoms of stuffy nose, runny nose, and/or sneezing in the absence of the common cold.

Given these results the researchers recommend that individuals with rhinitis be assessed for GERD.

Source: Schioler L, et al. Allergy. 2015 March.

Microbes Linked to the Production of Serotonin

June 4, 2015 – Results of a laboratory study suggest that certain bacteria in the gut play an important role in regulating production of the chemical neurotransmitter serotonin. While serotonin is commonly recognized as a signalling molecule in the brain, it is estimated that 90% of the body's serotonin is produced by cells in the gastrointestinal (GI) tract. Altered levels of serotonin in the gut have been linked to several chronic diseases, including irritable bowel syndrome (IBS).

The role that intestinal bacteria play in the function of certain components of the gut nervous system promises to be an exciting direction for future research in the field of functional GI disorders.

Source: Yano JM, et al. Cell. 2015 April.

FDA Approves rifaximin (Xifaxan) for Treatment of IBS-D in Adults

May 27, 2015 – The U.S. Food and Drug Administration (FDA) today approved rifaximin (Xifaxan®) for treating irritable bowel syndrome with diarrhea (IBS-D) in adult men and women. 

The safety and effectiveness of Xifaxan for treatment of IBS-D were established in three double-blind, placebo-controlled trials. In the first two trials, 1,258 patients were randomly assigned to receive Xifaxan or placebo for 14 days, and then followed for a 10-week treatment-free period. More Xifaxan-treated patients reported improvements in abdominal pain and stool consistency than those on placebo.

A third trial evaluated repeat courses of Xifaxan, because patients with IBS-D can develop recurrent signs and symptoms after a single treatment course of Xifaxan. A total of 636 patients with recurrence were randomized to receive either Xifaxan or placebo for two additional 14-day courses separated by 10 weeks. More patients treated with Xifaxan than placebo were responders in abdominal pain and stool consistency in this phase of the study.

The most common side effects in patients treated with Xifaxan for IBS-D include nausea and an increase in alanine aminotransferase (ALT), a liver enzyme measured in blood.

If diarrhea does not improve or worsens after treatment with Xifaxan, then evaluation for development of a severe infectious diarrhea, C. difficile enterocolitis, should be performed. Caution should be used when using Xifaxan in patients with severe liver impairment or when combined with certain other drugs.

Homeopathic Medicines to Receive Greater Scrutiny from the FDA?

May 26, 2015 – During a series of public hearings, the US Food and Drug Administration (FDA) took testimony on whether or not it should regulate natural preparations – derived from plants, minerals, and animals – in the same way it does over-the-counter drugs. If the FDA decides in favor of stiffer regulations, homeopathic products would have to demonstrate safety and effectiveness before they could go to market. The FDA would also have the power to review the products' labeling and to reject false or misleading claims.

Currently, homeopathic products are allowed to be sold without pre-market review of approval by the FDA. Over the past several decades, the market for homeopathics has boomed to become a multi-billion dollar industry, and concerns over safety have grown. Since 2009, the FDA has issued almost 40 warning letters regarding the safety of certain homeopathic products.

Source: FDA Public Hearing on Homeopathic Products Regulation Testimony. May 20, 2015.

New Recommendations Issued by the AGA on the Use of Endoscopes

May 21, 2015 – The American Gastroenterological Association (AGA) has issued best-practices recommendations for physicians on the use of endoscopes, devices used to look inside a body cavity or organ. These recommendations together with the results of an upcoming US Food and Drug Administration (FDA) Medical Devices Advisory Committee meeting with ensure that endoscopes meet a higher level of safety.

Source: AGA Press Releases. March 23, 2015.

Biofeedback Therapy for Bowel Disorders

May 7, 2015 – A joint American and European medical task force issued a position paper on the usefulness of biofeedback therapy for anorectal disorders. They concluded that, based on the strength of evidence, biofeedback therapy is recommended for short-term and long-term treatment of constipation with dyssynergic defecation and for the treatment of bowel incontinence. Several other specified uses were less strongly supported or not recommended.

The American Neurogastroenterology and Motility Society (ANMS) and the European Society of Neurogasteroenterology and Motility (ESNM) examined available evidence in order to provide the recommendations.

Source: Rao SSC, et al. Neurogastroenterol Motil. 2015 May.

New Device Approved by FDA to Treat Silent Reflux

May 4, 2015 – The US Food and Drug Administration (FDA) has approved a non-invasive medical device (Reza Band) to treat symptoms in individuals with silent reflux (also called laryngopharyngeal reflux). Unlike in gastroesophageal reflux disease (GERD), in silent reflux gastric contents are regurgitated into the larynx (often called the "voice box") and the pharynx. The device is worn while sleeping. It works by applying a slight pressure to the area below the Adam's apple, preventing the flow of gastric contents past the upper esophageal sphincter.

Symptoms of silent reflux include bothersome throat problems such as hoarseness, chronic cough, frequent throat clearing, and the sensation that something is stuck in the throat.

Source: FDAnews.com. 2015 March

Individuals with Fibromyalgia at Greater Risk for IBS

April 27, 2015 – A study of 33,729 individuals with newly diagnosed fibromylagia and 134,915 healthy controls randomly sampled from the Taiwan National Health Insurance Research Database between the years 2000 and 2011 found that presence of fibromyalgia was a significant risk factor for irritable bowel syndrome (IBS) when controlled for other factors, including sex, age, and the presence of other diseases. Treatment of fibromyalgia with antidepressants was also found to be a risk factor for IBS. Lastly, coexistence of certain other diseases along with fibromyalgia, including chronic liver or kidney disease, depression, anxiety, and sleep disorder was found to significantly increase risk for IBS.

From these findings the researchers suggest that individuals with fibromyalgia should be assessed regularly for other potential risk factors for IBS to reduce incidence.

Source: Yang TY, et al. Medicine. 2015 March.

C. difficile Infection in the US

April 20, 2015 – A 2011 survey estimated an incidence of C. difficile infection in the US of approximately 453,000 during the calendar year. Looking at a total of 15,461 active cases, the investigators found that two-thirds of C. difficile infections occurred in hospitals and nursing homes. Many infections were community-associated, meaning they happened among those who had not been inpatients in a health care facility. Common risk factors for C. difficile included female gender, Caucasian race, and being 65 years of age or older. More cautious prescribing of antibiotics and careful infection control in health care facilities can reduce the risk.

These results support the growing evidence that C. difficile is no longer restricted to hospital and other inpatient settings. Understanding risk factors and patterns of infection is important in infection prevention and treatment planning. This study was performed as part of the US Centers for Disease Control and Prevention (CDC) Emerging Infections Program (EIP).

Source: Lessa FC, et al. N Engl J Med. 2015 February.

New Test for Diagnosing Gastroparesis

April 11, 2015 – In April 2015, the U.S. Food and Drug Administration (FDA) approved a new non-invasive test of delayed gastric emptying to aid in the diagnosis of gastroparesis. Known as the Gastric Emptying Breath Test (GEBT), it can be performed in any clinical setting. 

Gastroparesis is a disorder that slows or stops the movement of food from the stomach to the small intestine in the absence of any observable obstruction or blockage. 

The GEBT is conducted over a four-hour period after an overnight fast. It is designed to show how fast the stomach empties solids by measuring carbon dioxide in a patient’s breath. Unlike scintigraphy, which uses a small amount of radioactive material to track gastric emptying, the GEBT uses no radioactive emitting material. Scintigraphy is considered the standard of care for measuring gastric emptying. 

The safety and effectiveness of the GEBT was studied in 115 participants prior to FDA approval. All participants were tested with both the GEBT and gastric scintigraphy. The GEBT results agreed with scintigraphy results 73-97 percent of the time when measured at various time points during the test.

People with hypersensitivity to Spirulina, egg, milk or wheat allergens should avoid the GEBT. The test also should not be administered to people with certain lung diseases or conditions that cause small bowel malabsorption. 

Source: FDA News Release, April 6, 2015

Registry Launched for Eosinophilic Gastrointestinal Diseases

April 10, 2015 – The Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR) has announced the launch of a new contact registry for eosinophilic gastrointestinal diseases (EGIDs), including eosinophilic esophagitis, eosinophilic gastroenteritis, and others. These are chronic inflammatory conditions believed to be triggered by food-related allergic hypersensitivity, which can lead to gastrointestinal symptoms.

Funded by the US National Institutes of Health (NIH), the goal of the registry is to provide an international database of contact data collected from patients and their families to CEGIR researchers for use in recruiting participants for new EGID studies. Individuals included in the registry will receive notifications of upcoming research studies for which they may be eligible as well as research updates, advocacy information, and opportunities to contribute to researcher training. The registry is online here.

Disease Burden in IBS-C and CIC

April 3, 2015 – In a US population-based survey of 328 individuals with constipation predominant irritable bowel syndrome (IBS-C) and 552 individuals with chronic idiopathic constipation (CIC), the researchers found that frequency and severity of symptoms were greater in IBS-C respondents than in respondents with CIC. However, in CIC respondents who also experienced frequent abdominal symptoms, such as pain and bloating, a similar disease burden to IBS-C respondents was evident.

Source: Heidelbaugh JJ, et al. Am J Gastroenterol. 2015 March.

Mesalazine Lacks Effectiveness for Individuals with IBS-D

April 3, 2015 – Researchers looked at an anti-inflammatory drug, mesalazine, to see if it would be useful for the treatment of diarrhea predominant irritable bowel syndrome (IBS-D). They found that the drug may improve symptoms in a subset of people with post-infectious IBS (PI-IBS).

The randomized placebo-controlled study included 136 individuals with IBS-D. Thirteen of these had PI-IBS.

Source: Lam C, et al. Gut. 2015 March.

Gut-Focused Hypnotherapy an Effective Treatment for IBS

April 3, 2015 – A study in the UK looked at the effectiveness of a gut-directed hypnotherapy technique in 1,000 patients with irritable bowel syndrome (IBS) whose symptoms were not adequately treated by conventional management strategies, such as dietary approaches and medications. The majority of participants improved and researchers concluded that the hypnotherapy relieved a wide range of symptoms, as well as improved quality of life and mood, safely and without side effects.

This therapy can be a helpful addition to conventional treatment measures, such as education, dietary and lifestyle changes, and drug therapy, in the treatment of IBS.

The patients received 12 weekly sessions of one-on-one gut-focused hypnotherapy from therapists at Wythenshawe Hospital, Manchester, UK who were trained and experienced using the technique. A study is ongoing to see if similar results can be achieved in a shorter time.

Source: Miller V, et al. Aliment Pharmacol Ther. 2015 March 

NIDDK Establishes Office of Nutrition Research

March 31, 2015 – This August the NIH National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) will establish the Office of Nutrition Research. This office will replace the NIH Division of Nutrition Research Coordination (DNRC). The new office will assist in leading a diverse group of offices within the NIH that will be responsible for planning new initiatives in NIH nutrition research. It will also be closely associated with the nutritional sciences grant funding programs in the NIDDK.

NIH, the National Institutes of Health, is the center for all federally-funded biomedical research in the US. The NIH conducts medical research; supports the research of non-federal scientists operating in universities, medical schools, hospitals, and research institutions throughout the country and abroad; helps in the training of researchers; and fosters communication of cutting-edge medical information. The NIDDK is the NIH's largest funder of nutrition research. Access the NIH website at www.nih.gov and the NIDDK website at www.niddk.nih.gov to learn more about all that they are responsible for.

A Cautious Approach to the Low-FODMAP Diet

March 26, 2015 – A review of published research looked at food intolerance associated with GI symptoms such as increased intestinal gas, abdominal pain, bloating, or diarrhea. Among the findings was increasing evidence that, for some people, a low FODMAP diet approach may be helpful in functional GI disorders when food intolerance is suspected.

However, there are cautions.

  • Measures used in various FODMAP research studies to date are not consistent
  • The dietary eliminations should be short-term
  • Certain gut microorganisms thought to be beneficial have been noted to be significantly decreased after 4 weeks of a low FODMAP diet
  • Nutritional adequacy may be reduced
  • The diet must be undertaken with the supervision of an experienced dietician (often a registerd dietician, or RD).

FODMAPs are a group of carbohydrates found in many common foods. The diagnosis of FODMAP intolerance is based on a short term (3–4 weeks) diet to reduce or exclude suspected foods to look for symptom improvement, followed by a gradual reintroduction to establish individual tolerance. It is essential to work with a dietician experienced in food intolerance in order to maintain adequate nutrition, minimize impact on the gut microbiota, and avoid unnecessary dietary restrictions.

Source: Lomer MCE. Aliment Pharmacol Ther. 2014 Dec.

Functional Gastrointestinal Disorders and BMI

March 20, 2015 – A prospective population-based cohort study of 35,447 individuals over the age of 18 found several significant relationships between body mass index (BMI) and risk for various functional gastrointestinal disorders (FGIDs). In adult females, high BMI was associated with an increased risk for functional diarrhea, and both high and low BMI were found to have a positive relationship with functional dyspepsia. In adult males, low BMI was found to be a risk factor for irritable bowel syndrome (IBS). Additionally, the study revealed significant overlaps in FGID diagnoses among participants, particularly between functional dyspepsia and IBS and functional constipation.

This analysis is part of the Nutrinet-Sante online study which was originally launched in France in 2009 but is still ongoing. For more information (in French) or to participate go to www.etude-nutrinet-sante.fr.

Source: Le Pluart D, et al. Aliment Pharmacol Ther. March 2015.

FDA Launches Mobile App to Track Drug Shortages

March 16, 2015 – The US Food and Drug Administration (FDA) has launched an application (app) for mobile platforms to increase public access to information about prescription drug shortages. The app provides real-time information about current drug shortages, resolved shortages, and discontinuations of drugs. Drugs can be searched for by generic or brand name or by therapeutic category.

The app is available for free download by going to this FDA webpage, or in the iTunes store (For iOS) and the Google Play store (for Android) by searching "FDA Drug Shortages".

Hiatal Hernia and Dyspeptic Symptoms in Children

March 10, 2015 – In a survey of 111 children undergoing upper endoscopy (EGD), presence of hiatal hernia was found to be associated with symptoms of heartburn and regurgitation but not other symptoms commonly described for gastroesophageal reflux (GER) or dyspepsia in children older than 4 years of age. Moreover, no association was found between presence of hiatal hernia and esophagitis.

The results of this study suggest that in children, presence of hiatal hernia represents a risk factor for only limited symptoms.

Source: Scarpato E, et al. J Pediatr Gastroenterol Nutr. December 2014.

Visceral Abdominal Fat Tied to an Increased Risk of IBS-D

March 5, 2015 – A case-controlled study of 336 individuals found that while overall body mass index (BMI) does not appear to be related to irritable bowel syndrome (IBS), abdominal fat deposits and waist circumference were both predictors of a higher risk of diarrhea predominant IBS (IBS-D).

From these findings the authors concluded that abdominal obesity, and not general obesity, represents a risk factor for IBS, especially IBS-D.

Source: Lee CG, et al. Am J Gastroenterol. January 2015.

Participants with Diabetic Gastroparesis Sought for Study

February 27, 2015 – A clinical study is seeking participants diagnosed with diabetic gastroparesis to assess the safety of a drug (IW-9179) in individuals with diabetic gastroparesis and its effects on the principal gastroparesis symptoms.  Find details and study locations on this ClinicalTrials.gov page. The study is sponsored by Ironwood Pharmaceticals.

Unhealthy Eating Behaviors and Functional Dyspepsia

February 24, 2015 – A survey in China of 1,341 individuals with functional dyspepsia (FD) found that those with FD were more likely to engage in unhealthy eating behaviors, including skipping meals, eating extra meals, and consuming large amounts of sweets and gas-producing foods, than healthy individuals. Moreover, these behaviors among individuals with FD were found to be risk factors for more difficult to treat (refractory) FD.

Source: Jiang SM, et al. J Dig Dis. December 2014.

Self-Applied Acupressure for Functional Constipation

February 16, 2015 – In a randomized clinical study, individuals with functional constipation who were taught how to apply external pressure (acupressure) to the perineum – the area between the anus and the genitals – in addition to standard therapies reported improved quality of life and bowel function compared with individuals who used only standard treatments. Standard therapies included increased dietary fiber intake, stool softeners, and exercise. A total of 91 people completed the study.

The UCLA researchers suggest that education in perineal self-acupressure, which only takes a few minutes to learn, should be included among other first-line treatments for functional constipation.

Source: Abbott R, et al. J Gen Intern Med. November 2014.

Location of Diverticular Disease and IBS

February 10, 2015 – A Japanese study of 1,009 individuals concluded that the location of diverticular disease is associated with a risk of irritable bowel syndrome (IBS). Diverticular disease occurring in the left-sided and bilateral sections of the colon, but not on the right side, was associated with a higher risk of IBS.

Clarifying the specific changes associated with left-sided diverticular disease could provide a better understanding of causes of IBS.

Source: Yamada E, et al. Am J Gastroenterol. December 2014.

Effect of Exercise on the Gut Microbiome and Health

February 3, 2015 – Researchers of a case-controlled study of 40 Irish athletes and 46 controls found that individuals who engaged in vigorous exercise had greater gut microbial diversity than those who did not. High diversity of gut microorganisms appears to be linked to decreased intestinal inflammation and improved immune function among other things.

Results of this study suggest that exercise has a beneficial effect on the gut microbiome. However, further investigation is needed to tease apart the effects of exercise from other variables, including diet, in promoting the diversity of gut microbes.

Source: Clarke SF, et al. Gut. December 2014. 

FDA Approves Generic Version of Nexium for GERD

January 28, 2015 – The U.S. Food and Drug Administration (FDA) has approved the first generic version of Nexium (esomeprazole magnesium) to treat gastroesophageal reflux disease (GERD) in adults and children aged 1 year and older. Esomeprazole is a proton pump inhibitor (PPI) that works by blocking the site of acid production in a particular cell group in the stomach (parietal cells).

Esomeprazole was first approved to treat GERD by the FDA as Nexium in 2001. It is also approved to reduce the risk for gastric ulcers associated with nonsteroidal anti-inflammatory drugs (NSAIDs), treat H. pylori infection in association with certain antibiotics, and treat conditions where the stomach produces too much acid (such as Zollinger-Ellison syndrome).

FDA Approves Neurostimulator to Treat Symptoms of Gastroparesis

January 26, 2015 – The U.S. Food and Drug Administration (FDA) has approved a second-generation neurostimulator device (Enterra II) to treat symptoms of nausea and vomiting in people with gastroparesis when other therapies have failed (refractory). The device is implanted under the skin and delivers a mild electrical pulse to stimulate the smooth muscles of the lower stomach. Enterra was first approved by the FDA in 2000. The new device provides physicians with greater system flexibility and ease of use.

Treatments are Needed for Functional Dyspepsia

January 16, 2015 – A survey of people with functional dyspepsia (FD) found that, although there is currently no drug approved to treat FD, respondents reported using an array of medications attempting to control symptoms. Moreover, one-half of the 114 respondents reported a willingness to take significant risks with a hypothetical medication that could cure their symptoms.

Better understanding of risk taking behavior can help inform drug development and approval processes as well as individual treatment approaches.

Source: Lacy B, et al. Clin Transl Gastroenterol. January 2015 

Maternal Inheritance in Adult Cyclic Vomiting Syndrome

January 13, 2015 – Researchers identified a higher probability of maternal inheritance of various functional gastrointestinal (GI) disorders in a subset of adults with cyclic vomiting syndrome (CVS) compared with healthy controls (12% compared to 1%).

More research studies to identify potential causes for maternal inheritance pattern in adults are warranted to help understand the underlying mechanisms of functional GI disorders.

Source: Venkatesan T, et al. BMC Gastroenterol. October 2014.

New Study to Look at Laxative Ingredient Safety in Children

January 8, 2015 – The US Food and Drug Administration (FDA) is funding a new study regarding the safety in children of PEG 3350 – the active ingredient in Miralax and similar generic laxatives. The FDA notes that there is little data on its absorption in children, especially in the very young and chronically constipated. Adverse events in children given the laxative have been reported, but it is not known whether the laxatives are the cause.

PEG 3350 laxatives, which are available over-the-counter, were FDA approved for persons aged 17 and older but never approved for long-term daily use. Talk to your doctor if you have a child who is using one of these laxatives.

Source: Saint Louis C. NY Times. January 2015.

Fear of IBS Symptoms Impacts Quality of Life

January 5, 2015 – A study of 234 individuals with irritable bowel syndrome (IBS) found fear of gastrointestinal (GI) symptoms of IBS to be strongly associated with reduced quality of life. Fear of symptoms was a stronger predictor of quality of life than symptom severity, personality style, sociodemographic variables, or overall emotional well-being.

Better understanding of the factors contributing to quality of life may help clinicians and patients assess, understand, and respond to changes in quality of life and improve IBS treatment outcomes.

Source: Lackner JM, et al. Am J Gastroenterol. November 2014.

Gut Microbes in IBS and Chronic Constipation

November 17, 2014 – Investigators in a systematic review and analysis combining existing randomized controlled studies (meta-analysis) concluded that for some people, probiotics (beneficial microorganisms) effectively benefit irritable bowel syndrome (IBS) symptoms such as abdominal pain, bloating, and gas.

However, it remains unclear which individual species and strains of probiotics are the most beneficial.

More evidence is also required before the role in IBS is known of prebiotics (which promote growth of probiotics) or synbiotics (which combine probiotics and prebiotics). The effectiveness of all three therapies in chronic idiopathic/functional constipation (CIC) is also lacking and uncertain.

Source: Ford AC, et al. Am J Gastroenterol. October 2014.

Scientists Create Model Human Stomachs to Study Gastric Diseases

November 10, 2014 – Using stem cells from adult donors, scientists have been able to grow pea-sized three-dimensional human stomach models under laboratory conditions. These miniature stomachs were developed to model mechanisms of infection by the bacterium Helicobacter pylori, which can cause gastric symptoms including nausea, bloating, and vomiting and can lead to ulcers and stomach cancer in extreme cases.

These models are expected to provide a valuable experimental model for the study of the development, functioning, and diseases of the human stomach.

Source: McCracken KW, et al. Nature. October 2014.

Key Symptoms in Functional Dyspepsia

November 6, 2014 – Researchers of a focus group study confirmed that symptoms corresponding to fullness after meals (postprandial) and early fullness (satiation) are the key symptoms for developing a patient reported outcomes (PRO) instrument for meal-related functional dyspepsia (FD)/postprandial distress syndrome (PDS). This information is useful for creating tools used to measure treatment effectiveness.

Under a program called PROMIS (Patient Reported Outcomes Measurement Information System), funded by the National Institutes of Health (NIH), PRO tools for various conditions are being developed which will help design treatment plans for individuals, improve doctor-patient communication, and manage chronic conditions.

Source: Carbone F, et al. Neurogastroenterol Motil. September 2014.

Yoga for Young People with IBS

October 30, 2014 – Researchers concluded that therapy for irritable bowel syndrome (IBS) using Iyengar yoga training – 1.5 hour sessions twice weekly for six weeks – is a safe and beneficial compliment to medical care in young people, particularly young adults.

The randomized controlled study involved an initial total of 51 participants including adolescents (ages 14–17) and young adults (ages 18–26) with IBS or recurrent abdominal pain. Physical functioning improved in adolescents, and IBS symptoms, emotional distress, fatigue, and sleep quality improved in young adults.

Iyengar yoga postures are taught in a sequence to address specific problems by teachers who receive training in anatomy, physiology, and safety.

Source: Evans S, et al. J Pediatr Gastroenterol Nutr. August 2014.

Preliminary News on Treatments Reported at the 2014 ACG Meeting

October 23, 2014 – Here are some brief reports on research studies that were presented as abstracts at the 2014 annual American College of Gastroenterology (ACG) Scientific Meeting, a conference for medical professionals.

The data and conclusions from these findings should be considered preliminary until published in a peer-reviewed journal.

Chronic Idiopathic/Functional Constipation (CIC)

  • Two-thirds of patients with CIC treated with lubiprostone (Amitiza) in three pivotal phase 3 studies in the US and Japan responded to the treatment after 2 weeks of therapy.

Dyspepsia and Chronic Idiopathic Constipation (CIC) with Bloating

  • Symptoms of functional dyspepsia (1 or more of feelings of fullness after a meal, early feeling of fullness, upper GI (epigastric) pain, or upper GI burning) are often reported by people with CIC with abdominal bloating. A study of CIC patients with abdominal bloating found that linaclotide (Linzess) provided significant relief for functional dyspepsia symptoms compared to placebo.


  • The majority of 138 patients with diabetic and idiopathic gastroparesis resistant to medical therapy (medically refractory) who were surveyed at least 6 months after being treated surgically with insertion of a gastric electric stimulator (GES) reported improvement of symptoms, especially loss of appetite, nausea, and retching (dry heaves).
  • Another study of 12 patients with medically refractory gastroparesis found improvement in nausea, vomiting, and nutritional parameters 5 years after GES therapy.
  • An evaluation of 31 patients with medically refractory gastroparesis found that after 1 year of GES those who also continued on prokinetic medications had improved symptom scores, greater weight gain, and decreased use of tube feeding (enteral nutrition) compared to those who discontinued prokinetic medications.

IBS in Children

  • A study involving 97 children and adolescents recently diagnosed with IBS found that two 90-minute sessions of multi-disciplinary behavioral therapy interventions significantly reduced healthcare utilization up to 4 years after diagnosis. The therapy included patient and parental education, dietary modification, exercise, relaxation techniques, and guided imagery.

IBS with Constipation (IBS-C)

  • Patients with IBS-C treated with linaclotide (Linzess) for up to 2 years were satisfied with treatment on average. The most frequent side-effect, diarrhea, was generally mild or moderate and easily managed.
  • Data from a phase 2 dose-ranging study of 424 adults to assess the safety and efficacy of plecanatide (a GC-C agonist) in patients with IBS-C concluded that the investigational therapy was well-tolerated and improved bowel habit and abdominal pain symptoms over a 12-week treatment period. (This agent is also in phase 3 trials for the treatment of chronic idiopathic constipation).

IBS with Diarrhea (IBS-D)

  • The investigational drug, eluxadoline, significantly improved IBS-D symptoms compared to placebo in patients enrolled in a study, including in those who had used loperamide without improvement in the prior year.
  • Another study found eluxadoline to significantly improve urgency, concluding this to be a valuable measure of response compared to placebo.
  • Based on results of a survey of IBS patients, researchers suggest that clinicians pay special attention in treatment plans to areas which affect quality of life, such as food avoidance, as well as to those that have effects on daily activities and relationships, especially in individuals with IBS-D.

IBS-D, IBS-C, and Mixed IBS (IBS-M)

  • A case series study over an 8-week period looked at treatment of 18 difficult to treat patients (14 with IBS, 2 with Crohn's disease, 2 with other bowel conditions) using the prescription oral medical food serum-derived bovine immunoglobulin/protein isolate (SBI) in addition to standards of care. Overall symptom improvement was seen in stool consistency, decreased stool frequency, abdominal pain, bloating, distension, and incontinence. The study concluded that dietary management with SBI can provide a safe and effective therapy for patients with IBS and other GI conditions.

Self-Help for IBS

  • Participants with IBS who completed a randomized, controlled, study of 6-week cognitive behavioral therapy using a self-help workbook experienced significant improvement in health related quality of life and symptom severity. Self-help workbooks designed to help manage psychological aspects of IBS can be added to medical management and may improve treatment outcomes.
  • Another study using a 9-week comprehensive self-management program designed for the treatment of IBS found that after 1 year the majority of participants still used some strategies from the program based on what was most effective for them. Strategies included meal timing/frequency, trigger food reduction, eating behaviors (like avoiding eating out and eating more slowly), eating a balanced diet, specific relaxation strategies, lifestyle behaviors (like exercise and hobbies), addressing thought distortions, challenging beliefs (like perfectionism and self-esteem), and problem-solving skills.

Structure and Functions of the Gut Microbiome

October 21, 2014 – In a published article, researchers describe how the understanding of human gut microbiology has undergone a leap forward over the past decade. The composition and function of the microbiome (the microbial gut community, especially bacteria), although stable over long periods, may be influenced by a number of factors including genetics, mode of birth delivery, age, diet, geographic location, and medical treatments.

Changes in the microbiome structure have been linked to inflammatory, functional, and metabolic disorders such as irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), and obesity. It remains to be known whether these changes are a contributing factor or a result of the disease.

Source: Panda S, et al. Endocr Metab Immune Disord Drug Targets. July 2014.

Integrated Treatments in IBS

October 16, 2014 – In a review of IBS treatment studies, investigators summarized the most widely used complementary and alternative medicine (CAM) approaches that have proven effectiveness and have been endorsed by professional organizations. Examples include specific modalities of hypnotherapy, cognitive behavioral therapy, acupuncture, and yoga.

The reviewers encourage the use of both conventional medicine and CAM approaches by doctors in an integrative setting to provide the best outcome and quality of life to affected individuals.

Source: Grundmann O, Saunjoo LY. World J Gastroenterol. January 2014.

Nortriptyline Lacks Effectiveness in Idiopathic Gastroparesis

October 16, 2014 – Researchers in a randomized controlled clinical trial concluded that, among patients with idiopathic gastroparesis, the use of the antidepressant nortriptyline compared with placebo for 15 weeks did not result in improvement in overall symptoms. These findings do not support the use of nortriptyline for idiopathic gastroparesis.

Gastroparesis remains a challenging syndrome to manage, with few effective treatments and a lack of rigorously controlled trials. Tricyclic antidepressants are often used to treat refractory symptoms of nausea, vomiting, and abdominal pain despite a lack of evidence from well-designed studies for this use.

Source: Parkman HP, et al. JAMA. December 2013.

Surveillance of Barrett's Esophagus Reduces Mortality from Esophageal Cancer

October 10, 2014 – Researchers in a large study concluded that monitoring individuals with Barrett's esophagus in an endoscopic surveillance program to watch for signs of abnormal tissue (dysplasia) or cancer was associated with lower tumor stages and reduced esophageal cancer-related mortality than those with Barrett's esophagus who did not participate in surveillance.

The study included 10,000 individuals diagnosed in the Netherlands with cancer of the esophagus. Nearly 800 (8%) of these had been diagnosed with Barrett's esophagus prior to the cancer diagnosis. Barrett's esophagus is one of several factors associated with increased risk of developing esophageal cancer. As with all cancers, early detection is critical to improving treatment outcomes. Learn more about Barrett's esophagus here

Source: Verbeek RE, et al. Am J Gastroenterol. August 2014.

Dietary Elimination Therapy for Eosinophilic Esophagitis

October 6, 2014 – A review of existing data of 31 individuals demonstrated that dietary elimination therapy is a safe and effective treatment in adults with eosinophilic esophagitis (EoE). Individuals underwent either a targeted elimination diet that isolated specific food allergies or a more general 6–food elimination diet. Individuals with EoE most frequently reacted to dairy (44%), eggs (44%), wheat (22%), shellfish (11%), legumes (11%), and nuts (11%).

While both diets were difficult for individuals to stick to, the targeted diet had greater success rates. Oral steroids and diet modification are the only therapies currently available for individuals with EoE.

Source: Wolf WA, et al. Clin Gastroenterol Hepatol. August 2014.

Biomarkers May Help Predict Risk for Barrett's Esophagus

September 22, 2014 – A study of 141 mostly white male veterans concluded that a prediction model based on a risk score of circulating levels of several specific substances in the blood (serum biomarkers) in addition to individual demographic and clinical information (age, sex, race, and waist-to-hip ratio as well as gastroesophageal reflux [GER] frequency and duration and H. pylori status) may help identify persons at risk for Barrett's esophagus more accurately than not including the multi-biomarker risk score.

More research is needed to validate these results in the general population and to see if there are additional biomarkers that can be included to improve the predictive value of this model even further.

Source: Thrift AP, et al. Clin Gastroenterol Hepatol. August 2014.

FDA Considers Rifaximin for Treatment of IBS-D

September 19, 2014 – The supplemental new drug application (sNDA) for rifaximin 550 mg has been accepted for review by the U.S. Food & Drug Administration (FDA). Rifaximin is an antibiotic under investigation for the treatment of irritable bowel syndrome with diarrhea (IBS-D). A decision from the FDA regarding the approval status of the drug is expected by Feb 28, 2015. Learn more

Symptom Episodes in IBS: Consequences for Treatment Procedure

September 18, 2014 – A study involving 185 individuals with irritable bowel syndrome (IBS) found that symptoms, including diarrhea, constipation, and abdominal pain, as well as bloating, tend to occur as episodes, over 2–4 days on average, rather than either sporadically or at regular intervals. Roughly half of individuals experienced a mixture of diarrhea and constipation episodes. Episodes of pain were not consistently relieved by a bowel movement or associated with a change in the frequency or consistency of stool.

Better understanding of the nature of episodic symptoms may help doctors and patients improve treatment regimens.

Source: Palsson OS, et al. Am J Gastroenterol. July 2014.

Statins May Reduce Risk of Barrett's Esophagus

September 9, 2014 – In a study of veterans, statin use was associated with a reduced risk of Barrett's esophagus. Statins are a class of drugs used to lower cholesterol.

This effect was most pronounced in obese individuals and those with a high waist to hip ratio (WHR). The study population included 303 individuals with Barrett's esophagus and 909 controls without Barrett's esophagus.

Source: Nguyen T, et al. Gastroenterology. August 2014.

6-Year Safety Report of the LINX System for GERD

September 9, 2014 – A safety analysis recently published for the LINX system magnetic sphincter augmentation device (MSAD) for gastroesophageal reflux disease (GERD) reported a low risk profile with no serious events leading to long-term complications associated with the device.

LINX is a surgically implanted device that works by reinforcing the lower esophageal sphincter (LES).

The first 1,000 individuals who underwent the procedure were reevaluated after 6 years. The analysis concluded that the safety profile for the procedure performed by an experienced surgeon establishes it as a viable option for individuals with uncomplicated GERD who are considering antireflux surgery

Source: Lipham JC, et al. Dis Esophagus. June 2014.

Gene Mutation Identified in IBS

September 5, 2014 – A survey of over 500 individuals confirmed a 2.2% prevalence of a mutation in a gene (SCN5A) in individuals with irritable bowel syndrome (IBS), as reported in an earlier pilot study. The SCN5A gene encodes a mechanism (sodium channels) involved in maintaining normal gastrointestinal (GI) motility.

The role of individual genes in symptom generation and expression in IBS remains largely unknown. Identification of these genes and their effects on the structure and function of the GI tract has the potential to reveal the mechanism of IBS in a subset of individuals with the disorder and shed light on new treatment pathways.

Source: Beyder A, et al. Gastroenterology. June 2014.

Different Anatomy in Individuals with GERD

September 5, 2014 – A study using magnetic resonance imaging (MRI) of 48 people found that those with mild to moderate gastroesophageal reflux disease (GERD) have several anatomical differences relating to the reflux barrier compared to healthy volunteers.

Primary among them, the angle of the esophagus (food tube) into the stomach was found to be wider in individuals with GERD compared with healthy individuals. This angle is an essential part of the way the body prevents reflux, called the "flap valve" mechanism. Also, the opening from the esophagus to the stomach (the esophagogastric junction), a key defense against the reflux of stomach contents after a large meal, was found to open wider in individuals with GERD. Differences in both of these structures in individuals with GERD are suspected to contribute to reflux.

Source: Curcic J, et al. Am J Gastroenterol. May 2014.

Newer Serotonin Drugs

August 13, 2014 – Researchers are finding new serotonin drugs that may help treat a variety of functional gastrointestinal (GI) disorders with improved safety.

A new generation of 5-HT4 receptor agonists is useful in treating symptoms of functional constipation, and have an improved safety profile compared to older drugs in this class.

A relatively new serotonin drug to treat irritable bowel syndrome with diarrhea (IBS-D) is also being developed. The drug, ramosetron (a 5HT3 receptor antagonist), has been associated with improved stool consistency in nearly 300 men with IBS-D in Japan. It appears to have an improved safety profile compared to other drugs in this class.

Source: Camilleri M. Neurogastroenterol Motil. August 2014.

GERD or Functional Dyspepsia?

August 13, 2014 – In a review of records, researchers at Mayo Clinic found an increase over a two decade period in gastroesophageal reflux disease (GERD) diagnosis rates, but no increase in reported GERD symptoms. About 6 out of 10 persons reporting GERD symptoms received a GERD diagnosis while only about 1 out of 10 persons reporting functional dyspepsia (FD) symptoms received an FD diagnosis.

Common symptoms of GERD – heartburn and/or acid regurgitation – are also reported in about one-third of people with FD. However, treatments differ for these 2 conditions and PPIs that treat GERD do not work for FD.

Source: Pleyer C, et al. Neurogastroenterol Motil. August 2014.

Microbiota Transplant for Treatment of C. difficile

August 12, 2014 – A study involving existing medical information collected on 75 adults and 5 children from 16 different medical centers concluded that fecal microbiota transplant (FMT) appears to be safe and effective for treating C. difficile infection in people who have weakened immune systems.

Up to 15–20% of cases of antibiotic-associated recurrent diarrhea and colitis presented in hospitals are attributed to C. difficile infection. FMT helps restore the balance of beneficial microorganisms lost to antibiotic use, and is indicated for people who have not been helped by standard therapies for C. difficile. However, the use of this treatment among individuals with weakened immune systems has been limited due to concerns about safety.

Source: Kelly CR, et al. Am J Gastroenterol. July 2014.

Acid Reflux Therapy

August 12, 2014 – Proton pump inhibitors (PPIs) reduce stomach acid production and are widely used to treat gastroesophageal reflux disease (GERD). However, in about 30% of patients PPIs do not adequately resolve symptoms.

Researchers looking at the occurrence of acid reflux events concluded that strategies which target the pool of acid (called the acid pocket) that floats on the top of ingested food after a meal may be effective for people with GERD who are not helped by PPIs alone.

Altering the size, position, and acidity of the acid pocket while using a PPI may add therapeutic benefit.

Source: Rohof WO, et al. Clin Gastroenterol Hepatol. July 2014.

Naloxegol Indicated for Opioid-Induced Constipation

August 11, 2014 – In two large phase 3 studies, the drug naloxegol was assessed for safety and efficacy in the treatment of opioid-induced constipation in individuals taking opioids for non-cancer related pain. At daily doses of both 12.5 mg and 25 mg the drug was associated with a significant reduction in constipation symptoms. Side effects were more frequent at higher doses and most often included gastrointestinal (GI) effects (abdominal pain, diarrhea, nausea, and vomiting).

Naloxegol is a member of an emerging class of drugs (peripherally acting µ-opioid receptor antagonists) that decrease the GI side effects of opioids without reducing their painkilling effects. Naloxegol is indicated for use by individuals suffering from opioid-induced constipation who have not responded satisfactorily to standard laxative therapy.

Source: Chey WD, et al. New Engl J Med. June 2014.

Authors Call for Standardization of the Decision to Refer for Anti-Reflux Procedures

August 11, 2014 – No current standards exist regarding decisions by medical professionals to refer children with severe gastroesophageal reflux disease (GERD) for anti-reflux procedures, including surgery. Decisions may be greatly influenced by parental and referring physician opinions. Standardization based on data showing the safety and effectiveness of treatments is recommended by the authors.

Source: Papic JC, et al. Surgery. May 2014.

IBS and IBD Similarities

August 8, 2014 – A review of existing studies of inflammatory bowel disease (IBD) and of irritable bowel syndrome (IBS) found a number of shared factors contributing to both disorders. In some instances these shared factors may involve brain-gut dysfunction, genetics, abnormal microbiota, low-grade inflammation in some IBS patients, and IBS symptoms in some patients with IBD in remission.

Source: Barbara G, et al. Curr Opin Gastroenterol. May 2014.

Probiotics in Constipation and IBS

August 8, 2014 – A review of existing randomized controlled studies aimed to summarize the usefulness of probiotics in health and disease. The researchers concluded that certain strains or combinations may be of benefit in managing constipation and in improving irritable bowel syndrome (IBS) symptoms, among other things. The summary is intended to provide a guide to healthcare providers working with patients.

Source: Taibi A, Comelli EM. Appl Physiol Nutr Metab. May 2014.

Targeting IBS Treatment 

August 8, 2014 – Researchers reviewing existing studies found an imbalance of certain cells (cytokines) involved in regulating inflammation and sensitization in people with irritable bowel syndrome (IBS) compared to people without IBS. Using a cytokine profile may eventually be one way to help individualize treatment for people with IBS.

Source: Bashashati M, et al. Neurogastroenterol Motil. May 2014.

Non-Intestinal Symptoms in Childhood Predict IBS in Adulthood

August 8, 2014 – Recent findings suggest that symptoms existing outside the intestinal tract, such as reflux, joint pain, skin abnormalities, and psychological dysfunction, in association with childhood functional abdominal pain are significant predictors of the development of functional gastrointestinal disorders, particularly irritable bowel syndrome (IBS), in adulthood.

Source: Horst S, et al. Clin Castroenterol Hepatol. April 2014.

Foods that Worsen GI Symptoms

August 8, 2014 – A study of 25 children with functional gastrointestinal (GI) disorders revealed that specific foods are perceived by children to worsen their GI symptoms. These most often included spicy foods, cow’s milk, and pizza. Common coping strategies identified were consuming smaller portions, modifying foods, and avoiding problem foods.

Source: Carlson M, et al. J Acad Nutr Diet. March 2014.

New Guidance on Treatments for Sphincter of Oddi Dysfunction

August 8, 2014 – Results of a new study indicate that ERCP and surgery (sphincterotomy) are not reliably effective treatments of pain resulting from sphincter of Oddi dysfunction (SOD). Because these procedures carry substantial risk, the authors do not recommend the continued use of ERCP and sphincterotomy for abdominal pain following cholecystectomy – removal of the gallbladder.

SOD describes a condition in which the sphincter does not relax at the appropriate time, most often due to scarring or muscle spasm. The back-up of digestive juices that results can cause episodes of severe abdominal pain.

Source: Cotton PB, et al. JAMA. May 2014.

Home Parenteral Nutrition for Infants with Ultra-Short Bowel Syndrome

August 8, 2014 – Because of the long-term complications associated with intestinal transplantation, the authors in a new study for the treatment of infants with ultra-short bowel syndrome (U-SBS) recommend a non-transplant home parenteral nutrition approach (in the absence of liver disease).

Parenteral nutrition is an intravenous feeding technique that delivers nutrition directly into the blood stream.

Source: Diamanti A, et al. J Ped Gastroenterol Nutr. April 2014.

Restrictive Eating and Abnormal Gut Function

August 8, 2014 – Results from a preliminary study of adolescents with irritable bowel syndrome (IBS) suggest that frequent bouts of restrictive eating – such as not eating when hungry or eliminating certain foods – are associated with abnormalities in gastric sensation and gut motility. These gastrointestinal symptoms have been noted in association with other conditions characterized by restrictive eating. Results of this study warrant further investigation.

Source: Van Tilburg MAL, et al. J Ped Gastroenterol Nutr. April 2014.

Guidance Issued in UK for Amitiza in Treating Chronic Idiopathic Constipation

July 23, 2014 – The National Institute for Health and Care Excellence (NICE) has issued guidance on the use of lubiprostone (Amitiza) for treating chronic idiopathic constipation in the United Kingdom. The guidelines stipulate that the drug should only be considered in adults who have tried at least 2 laxatives at the highest tolerated recommended doses for at least 6 months, but who have not seen an improvement in their symptoms. 

NICE clinical guidelines are recommendations on the appropriate treatment and care of people with specific diseases and conditions within the National Health Service (NHS) in the UK. 

Results Positive in Study of Rifaximin Repeat Treatment for IBS-D

July 1, 2014Salix Pharmaceuticals reported positive results from the TARGET 3 – Phase 3 study to evaluate the efficacy and safety of repeat 14 day treatment with rifaximin for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in people who responded to an initial 14 day treatment course with rifaximin. Compared to placebo, subjects treated with rifaximin showed statistically significant improvement in IBS-related abdominal pain and stool consistency during the 4 week treatment-free follow-up period in the double blind repeat treatment phase.

Study Underway to Evaluate new GERD Treatment

June 30, 2014 – A phase 2 study is underway on a new drug to treat gastroesophageal reflux disease (GERD) in patients not adequately helped by proton pump inhibitors (PPIs). The study will assess the effect of the drug (IW-3718) compared to placebo as an added treatment in GERD patients who will continue to also take a once-daily PPI. Ironwood Pharmaceuticals is developing the drug.  

Prevalence of Fructose Malabsorption in Irritable Bowel Syndrome (IBS)

May 28, 2014 – Fructose can trigger or worsen symptoms in irritable bowel syndrome (IBS). A new study investigated the prevalence of symptomatic fructose malabsorption in those with IBS and tested whether any patient characteristics can help to detect fructose malabsorption.

After ingesting 25g of fructose, fructose malabsorption was found in 22% of those studied. Symptoms indicating intolerance to fructose were found in 28% of sampled individuals, not all of whom demonstrated malabsorption. There were no differences in IBS subtype or clinical symptoms between those who did or did not have malabsorption. However, young males had a greater incidence of malabsorption.

The authors recommend further studies to determine whether a low-fructose diet would help IBS patients who are intolerant to fructose, with and without malabsorption.

Chronic Constipation Associated with Increased Risk for Colorectal Tumors

May 20, 2014 – A retrospective database study of existing records has found that people with diagnoses of severe chronic constipation (CC) have a potentially higher risk of developing colorectal cancer and non-cancerous (benign) colorectal tumors over time, compared to people without CC.

The study, which looked at medical record databases, reviewed data from over 100,000 patients (28,854 patients with CC and 86,562 without) for 2–5 years. In those with CC, 2.7% developed colorectal cancer vs. 1.7% of those without. For non-cancerous colorectal tumors, the proportion was 24.8% for those with CC and 11.9% for those without. The risks increased with the severity of the chronic constipation.

These findings demonstrate an association only – not a causation – between chronic constipation and the development of colorectal cancer and/or benign tumor. While further studies are needed to determine whether there is an underlying causal link, the authors recommend that doctors be aware of this potential association in order to monitor and treat their patients appropriately.

Bowel Disease A-To-Z Guide Launched In UK

May 09, 2014 – The Association of Coloproctology of Great Britain and Ireland has launched a guide on their website to help patients find expert surgeons. The guide classifies surgeons by location as well as by their interest a large variety of different bowel conditions.

UK residents who need surgery as part of their treatment can use the guide to find a surgeon who specializes in their condition.

The guide can be found here: http://www.acpgbi.org.uk/specialists/

Industry Treatment News
Eluxadoline (Viberzi)
Eosinophilic Esophagitis Study
Linaclotide (Linzess)
Linaclotide Study for IBS in Children
Linaclotide Study for FC in Children
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2016-1115 GERD is More Than Simple Heartburn
2014-1119 Persistent Heartburn May Be a Sign of GERD
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