Here is a sampling of research 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.
Topics – Newest Postings Listed First
- FDA authorizes marketing of new device designed to remove dead pancreatic tissue
- FDA Takes Further Steps to Confront Opioid Crisis Through Risk Evaluation and Mitigation Strategy Programs
- FDA Encourages Manufacturers to Clearly Declare All Uses of Sesame in Ingredient List on Food Labels
- FDA Offers Guidance to Enhance Diversity in Clinical Trials, Encourage Inclusivity in Medical Product Development
- FDA awards six grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases
- FDA Recommends Health Care Professionals Discuss Naloxone with All Patients when Prescribing
- FDA Approves First Liquid Biopsy Next-Generation Sequencing Companion Diagnostic Test
- FDA Finalizes Rule Related to Gluten-Free Labeling for Foods Containing Fermented, Hydrolyzed Ingredients
- European Consensus Statement Published on OIC
- Wireless motility capsule (WMC) has been proposed as an alternative method for diagnosis of gastroparesis
- Center for Pediatric Research Added to Gastroparesis Clinical Research Consortium (GpCRC)
- New Study Finds Home-Based CBT Treatment Program Provides Enduring Symptom Relief for IBS Patients
- Symptoms Typical in GERD May Delay Diagnosis in People with Untreated Achalasia
- Healthcare Utilization and Costs Associated with Gastroparesis
- Conclusions of the AGA Drug Development Conference on Upper GI Disorders
- Patient Perspectives on Most Important Study Endpoints for Fecal Incontinence
- Nasal Symptoms of Laryngopharyngeal Reflux (LPR) Improve with Antireflux Medication
- Barriers to Seeking Care for Fecal Incontinence
- Many with IBS-Related Symptoms Go Undiagnosed
- Class of Drugs Concluded to be Effective in the Treatment of Non-Constipated IBS and IBS-D
- News Updates from DDW 2017
- FDA Advisory Panel Warns Against Analgesic-Antacid Combination for Upper GI Symptoms
- Eluxadoline Approved in Canada
- Brain-Gut Microbiome Interactions in People with IBS
- Taste and Smell Abnormalities in Gastroparesis and GERD
- Dyspepsia Symptoms Associated with Reduced PPI Response in People with GERD
- Caution Associated with Gluten-Free Diet
- Gut Microbiota Signature Associated with IBS Severity
- FDA Warns of Serious Risk in Patients without a Gallbladder taking IBS drug Viberzi
- Do Children Grow Out of IBS?
- Red Meat Consumption Linked to Diverticulitis Risk in Men
- FDA Approves New Dose of Linaclotide for Constipation
- Diagnostic Language Affects Care in Functional GI Disorders
- Gastroparesis in the Community Research Survey Published
- FDA Approves Plecanatide for Treatment of Chronic Idiopathic Constipation in Adults
- Current Evidence Not Enough to Support Medical Marijuana for IBS Treatment
- Abnormal Sensation Linked to Carbohydrate-Related Symptoms in IBS
- NIH Task Force Develops First Strategic Plan for Nutrition Research
- Overlap of Functional Abdominal Pain Syndrome and IBD in Children
- Migraine Associated with Certain Functional GI Disorders in Children
- Genetic Variants in Digestion of Certain Carbohydrates Associated with Risk of IBS
- Acid Blockers Risk Factor for Iron Deficiency
- Positive Early Data Reported for Investigational Linaclotide CR2 and CR1 Formulations
- Linaclotide (Linzess) for Treatment of IBS-C Approved in Japan
- Medical News Reported at the 2016 FNM Meeting
- New Drug Study Reports Improvement of Symptoms of IBS-C
- Medical News Reported at the 2016 ACG Meeting
- Drug Development Conference Addresses Current Challenges and Emerging Solutions in the Upper GI Disorders
- Swallowed Flonase Effective for Long-Term Management of EoE in Children
- An Association Observed Between the Inflammatory Condition, Rosacea, and Certain GI Disorders
- Relamorelin Found to Reduce Symptoms in Adults with Diabetic Gastroparesis
- C. difficile Infection May Be a Risk Factor for IBS
- New Breath Test for Gastroparesis
- Nausea and Vomiting in Gastroparesis
- Environmental Roles in Disease
- Rome IV Released at DDW
- Medical News Reported at the 2016 DDW Meeting
- Mirtazapine Found to Reduce Some Symptoms of Functional Dyspepsia
- High Prevalence of Functional GI Disorder Diagnoses in Pediatric Outpatient Clinic
- Preliminary Results Announced for OIC Treatment
- IBS Associated with Vitamin D Deficiency
- Eluxadoline (Viberzi) Effective in the Relief of IBS-D Symptoms
- Nutrition Research Roadmap Released
- Patient Experiences of Foods on Gastroparesis Symptoms
- Psychological Therapies Found to Reduce Symptoms of IBS
- Treatment Approved by FDA for Fecal Incontinence
- National Survey Finds GI Disorders Continue to be Source of Substantial Burden and Cost
- IBS Treatment More Cost Effective in Primary Care Settings
- Transoral Incisionless Fundoplication for GERD
- NIH Releases Strategic Plan through Year 2020
- Funding Support for Digestive Conditions Research in the US FY 2016 Budget
- Assessment of Long-Term GES in Children with Gastroparesis
December 23, 2020 – Today, the U.S. Food and Drug Administration authorized marketing of the EndoRotor System to resect (cut out) and remove necrotic (dead) tissue for patients with walled-off pancreatic necrosis (WOPN), a potentially deadly condition which can occur several weeks after an episode of severe acute pancreatitis, often requiring tissue removal.
“This device has shown its potential to provide a minimally invasive way to remove harmful necrotic pancreatic tissue in patients with walled-off pancreatic necrosis, which occurs in about 15 percent of patients with severe pancreatitis,” said Charles Viviano, M.D., Ph.D., acting director of the Reproductive, Gastro-Renal, Urological, General Hospital Device and Human Factors Office in the FDA’s Center for Devices and Radiological Health. “Currently, in order to remove dead tissue from a patient’s necrotic pancreatic cavity, health care providers need to perform an invasive surgery or use other endoscopic tools not specifically indicated to treat this condition. With today’s marketing authorization, patients with walled-off pancreatic necrosis now have a new treatment option.”
You can read more here.
FDA Takes Further Steps to Confront Opioid Crisis Through Risk Evaluation and Mitigation Strategy Programs
December 23, 2020 – The FDA remains committed to using all facets of our regulatory authority to lessen the impact of opioid addiction, misuse, and abuse while also striking a careful balance between patient access and safety to ensure that patients suffering from significant pain have access to appropriate medication.
To that end, the FDA has been and continues to address this public health crisis on a number of fronts, including efforts to:
Decrease unnecessary exposure to prescription opioids and prevent new addiction;
Support the treatment of those with opioid use disorder;
Foster the development of new and effective pain therapies; and
Take action against those who contribute to the illegal importation and sale of opioid products.
Part of our regulatory authority efforts include requiring Risk Evaluation and Mitigation Strategies (REMS) for various opioid analgesics to help mitigate the serious risks associated with their use.
You can read more here.
FDA Encourages Manufacturers to Clearly Declare All Uses of Sesame in Ingredient List on Food Labels
November 10, 2020 – The U.S. Food and Drug Administration today issued a draft guidance encouraging food manufacturers to voluntarily declare sesame in the ingredient list on food labels.
“Many Americans are allergic or sensitive to sesame, and they need the ability to quickly identify products that might contain sesame,” said Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition. “While most products containing sesame declare it as an ingredient, there are times when sesame is not required to be declared by name on the label, such as when it is used as a ‘flavor’ or ‘spice.’ Other ingredients, like ‘tahini,’ are made by grinding sesame into a paste, but not all consumers are aware that tahini is made from sesame. In these instances, sesame may not be declared by name in the ingredient list on a product’s label. We are encouraging food manufacturers to voluntarily list sesame as an ingredient whenever a product has been made with sesame.” You can read more here.
FDA Offers Guidance to Enhance Diversity in Clinical Trials, Encourage Inclusivity in Medical Product Development
November 9, 2020 – The final guidance issued today, “Enhancing the Diversity of Clinical Trial Populations–Eligibility Criteria, Enrollment Practices, and Trial Designs,” which was first issued as a draft in 2019, provides the agency’s current thinking on steps to broaden eligibility criteria in clinical trials through inclusive trial practices, trial designs, and methodological approaches. The guidance aims to provide recommendations for how sponsors can increase enrollment of underrepresented populations in their clinical trials.
This guidance offers recommendations on how product sponsors can improve clinical trial diversity by accounting for logistical and other participant-related factors that could limit participation. For example, clinical trials requiring frequent visits to specific sites may place an added burden on participants. Sponsors are encouraged to think about reducing visit frequency, when appropriate, in addition to considering whether flexibility in visit windows is possible and whether electronic communications, such as phone, email, social media platforms, or other digital health technology tools can replace site visits and provide investigators with real-time data. You can read more here.
FDA awards six grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases
October 8, 2020 – Today, the U.S. Food and Drug Administration announced that it has awarded six new clinical trial research grants to principal investigators from academia and industry totaling over $16 million over the next four years. These trial research grants, awarded through the Congressionally-funded Orphan Products Grants Program, enhance the development of medical products for patients with rare diseases.
“Now, more than ever, we see the important role of these FDA grants to support clinical trials of potentially life-changing treatments for patients with rare diseases,” said FDA Commissioner Stephen M. Hahn, M.D. “As interest in the program has grown, so has the hope for promising approved therapies for patients with rare diseases that currently have no treatment options. These important clinical trials are at a critical time where additional resources are needed to support rare disease research during the COVID-19 pandemic.”
Two of the rare diseases selected are pancreatic cancer and cystic fibrosis. You can read more here: https://www.fda.gov/news
July 23, 2020 – FDA is requiring drug manufacturers for all opioid pain relievers and medicines to treat opioid use disorder (OUD) to add new recommendations about naloxone to the prescribing information. This will help ensure that health care professionals discuss the availability of naloxone and assess each patient’s need for a naloxone prescription when opioid pain relievers or medicines to treat OUD are being prescribed or renewed. The patient Medication Guides will also be updated.
Opioid pain relievers are medicines that can help manage pain when other treatments and medicines are not able to provide enough pain relief. Certain opioids are also used to treat OUD. Opioids have serious risks, including misuse and abuse, addiction, overdose, and death. Naloxone can help reverse opioid overdose to prevent death.
The misuse and abuse of illicit and prescription opioids and the risks of addiction, overdose, and death are a public health crisis in the United States. As a result, FDA is committed to encouraging health care professionals to raise awareness of the availability of naloxone when they are prescribing and dispensing opioid pain relievers or medicines to treat OUD. FDA held discussions about naloxone availability with the Anesthetic and Analgesic Drug Products and the Drug Safety and Risk Management Advisory Committees, which recommended that all patients being prescribed opioids for use in the outpatient setting would benefit from a conversation with their health care professional about the availability of naloxone.
August 11, 2020 -Today, the U.S. Food and Drug Administration approved the first liquid biopsy companion diagnostic that also uses next-generation sequencing (NGS) technology to identify patients with specific types of mutations of the epidermal growth factor receptor (EGFR) gene in a deadly form of metastatic non-small cell lung cancer (NSCLC). This is the first approval to combine two technologies — NGS and liquid biopsy — in one diagnostic test in order to guide treatment decisions. “Approval of a companion diagnostic that uses a liquid biopsy and leverages next-generation sequencing marks a new era for mutation testing,” said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “In addition to benefitting from less invasive testing, patients are provided with a simultaneous mapping of multiple biomarkers of genomic alterations, rather than one biomarker at a time, which can translate to decreased wait times for starting treatment and provide insight into possible resistance mechanisms.”
FDA Finalizes Rule Related to Gluten-Free Labeling for Foods Containing Fermented, Hydrolyzed Ingredients
August 12, 2020 – The U.S. Food and Drug Administration issued a final rule to establish compliance requirements for fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients, and that bear the “gluten-free” claim. The rule pertains to foods such as soy sauce, yogurt, sauerkraut, pickles, cheese, distilled foods, and green olives. For those with celiac disease, foods that contain gluten trigger production of antibodies that attack and damage the lining of the small intestine. Such damage limits the ability of people with celiac disease to absorb nutrients and puts them at risk of other serious health problems, including nutritional deficiencies, osteoporosis, growth retardation, infertility, miscarriages, short stature and intestinal cancers. This requirement will help further protect individuals living with celiac disease. Read the full report.
May 13, 2019 – Initiated to provide clinical guidance for the identification and management of opioid-induced constipation (OIC), a European consensus statement entitled “Pathophysiology and Management of Opioid-Induced Constipation” was recently published in the United European Gastroenterology (UEG) Journal. Included in this statement was the finding that OIC remains an under-recognized and under-treated health concern, affecting 51-87% of cancer patients receiving opioids and approximately half (41-57%) of patients taking opioids for non-cancer pain.
According to the statement, OIC represents a significant clinical problem that must be approached differently from other types of constipation. Unlike other types of constipation, individuals with OIC may have many, varied symptoms and do not always associate their symptoms with medically-significant constipation. This presents a barrier to the timely diagnosis and treatment of the condition. Greater awareness of OIC and the availability of new targeted treatments is necessary to improve recognition and management.
Source: Farmer AD, et al. United European Gastroenterol J. February 2019.
Wireless motility capsule (WMC) has been proposed as an alternative method for diagnosis of gastroparesis
February 5, 2019 – Gastric emptying scintigraphy (GES) is the most commonly ordered motility test to diagnose gastroparesis. However, this test may be limited by lack of standardization across centers as well as exposure to radiation. Wireless motility capsule (WMC) has been proposed as an alternative method for diagnosis of gastroparesis. This is a small capsule that is swallowed after ingestion of a protein bar and collects data on transit and pressure information in the stomach, small intestine, and colon. Prior studies have demonstrated good agreement between WMC and GES but these findings have not been validated.
In a multicenter trial, investigators across 10 centers in the US recruited 167 individuals with symptoms suggestive of gastroparesis. They found that WMC detected a significantly higher rate of patients with delayed gastric emptying compared with GES (34.6% vs. 24.5%). In addition, there were important differences between diabetic and non-diabetic patients in this study. In non-diabetic patients, which accounted for approximately 2/3rds of the study population, delayed gastric emptying was more frequently detected by WMC compared to GES (33.3% vs. 17.1%). Meanwhile, diabetic individuals were more likely to have delayed GES when compared with those without diabetes (41.7% vs. 17.1%). Furthermore, nearly half of all patients had small bowel and/or colonic transit abnormalities which would not be detected with GES alone. This was particularly true in non-diabetic patients who showed higher rates of small bowel transit delay and generalized delay compared with diabetic patients.
These results suggest that WMC provides a higher diagnostic yield compared with GES in individuals with suspected gastroparesis, including delayed gastric emptying as well as extra-gastric transit abnormalities. Further studies are currently underway to determine the clinical relevance of these findings.
By: Allen Lee, MD, Michigan Medicine, University of Michigan, MI.
May 9, 2018 – Previously considered rare, there is growing recognition in the medical community of gastroparesis in children and adolescents. To address this, the Children’s Nutrition Research Center at Baylor College of Medicine in Houston, Texas joined the Gastroparesis Clinical Research Consortium (GpCRC) earlier this year.
Sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the branch of the National Institutes of Health (NIH) concerned with digestive diseases and related conditions, the GpCRC was formed to address challenges to gastroparesis research, such as isolated research centers, small study populations, and limited research techniques. By coordinating the research efforts of investigators and centers across the country, the GpCRC provides an infrastructure for the design and conduct of large, multi-center clinical research studies.
The Children’s Nutrition Research Center joins ten other member research centers and will be involved in future research efforts looking into the treatment of gastroparesis in children and teens.
Click to learn more abou the GpCRC.
April 23, 2018 – For the 35 million Americans that suffer from irritable bowel syndrome (IBS), abdominal pain and bowel problems can be a significant source of distress, disability, and quality of life impairment. This is aggravated by the lack of satisfactory medical or dietary treatments for the full range of IBS symptoms.
There is now reason to believe that very real hope is on the horizon. In a groundbreaking multi-site study funded by the National Institute of Health (NIH), Dr. Jeffrey Lackner, Professor of Medicine at the Jacobs School of Medicine at the University of Buffalo, and colleagues found that a home-based treatment called cognitive behavior therapy (CBT) was more effective than an education intervention, and comparable to more resource-intensive clinic-based behavioral treatment for improving gastrointestinal (GI) symptoms that were highly resistant (refractory) to conventional medical treatments. CBT is a psychological treatment that teaches practical skills for changing specific behaviors and thinking styles that dysregulate brain-gut interactions and generate GI symptoms. To evaluate the efficacy of home-based CBT among patients with more severe IBS, 436 adults with moderate-to-severe IBS (86% women; mean age, 41 years) from the University at Buffalo or Northwestern University were randomly assigned to receive standard cognitive behavior therapy (CBT; 10 clinic sessions administered by a clinician), minimal contact CBT or MC-CBT (four clinic sessions), or general IBS education (four sessions). Whether patients reported moderate to substantial improvement of IBS symptoms served as the primary endpoint. Both CBT treatments focused on information on brain-gut interactions, self-monitoring of symptoms, triggers and consequences, worry control, muscle relaxation, flexible problem-solving, and ways to maintain gains. Education emphasized support and information about IBS, its clinical features, epidemiology, diagnostic criteria, medical tests, and treatment options as well as the role of stress in IBS, diet, and physical activity without the behavior changes prescribed in CBT.
In the intent-to-treat analysis, significantly more patients reported global improvement of IBS symptoms with minimal contact CBT vs. IBS education at 2 weeks after the treatment period ended (61% vs. 43%; P < .01), as did patients who received standard CBT (55%; P < .05 vs. IBS education). Board certified gastroenterologists masked to the assigned treatments rated IBS symptom improvements similarly to those reported by patients. Unlike drug treatments whose therapeutic benefits are symptom-specific and typically erode after treatment discontinuation, treatment benefits of CBT generally persisted for at least 6 months after treatment ended. The severity of IBS symptoms was also examined over time using the IBS Symptom Severity Scale.
IBS severity scores decreased dramatically over time in all conditions, particularly MC-CBT. At an aggregate level, the severity of IBS symptoms among MC-CBT patients fell to mild levels in the 3-month follow-up period. Long term follow-up data is forthcoming.
By: Jeffrey Lackner, MD, Jacobs School of Medicine, University of Buffalo, NY.
September 28, 2017 – Findings in a review of the medical records of 64 patients with a diagnosis of achalasia in South Korea suggest that achalasia should be suspected in patients with gastroesophageal reflux disease (GERD) that is resistant to treatment (refractory). Symptoms associated with GERD, such as regurgitation and heartburn, were present in more than 50% of these patients, who experienced symptom onset an average of 2 years before obtaining the appropriate diagnosis.
Source: Jeon HH, et al. J Neurogastroenterol Motil. July 2017.
September 21, 2017 – A study using the National Inpatient Sample Database, which includes approximately 95% of the US population, to estimate the annual number of gastroparesis related hospitalizations during the period 1997-2013, concluded that the number of inpatient admissions for gastroparesis and associated costs have increased significantly over the last 16 years. Inpatient costs associated with gastroparesis contribute significantly to the national healthcare bill. Further research on cost-effective evaluation and management of gastroparesis is required.
Source: Wadhwa V, et al. World J Gastroenterol. June 2017.
September 8, 2017 – In November 2016 IFFGD attended the first Drug Development Conference sponsored by the Center for Diagnostics and Therapeutics (CDT) of the American Gastroenterological Association (AGA), an organization for medical professionals in the field of gastroenterology. The aim of the meeting was to bring together physicians, researchers, representatives from the US Food and Drug Administration (FDA), and patients to discuss current unmet needs and future strategies for treatment in 4 disorders of the upper gastrointestinal (GI) tract: gastroesophageal reflux disease (GERD) that is incompletely responsive to acid inhibition, eosinophilic esophagitis (EoE), gastroparesis, and functional dyspepsia.
The conclusions of this meeting were used to prepare 4 white papers, one for each disease area. In August 2017, these papers were published in the peer-reviewed medical journal Clinical Gastroenterology and Hepatology.
Several major themes were revealed:
- Diagnosis of these conditions may be complicated by overlap with other GI conditions.
- Patient-reported outcomes (PROs) are important measures for determining the symptoms that are most bothersome for patients and should be used as endpoints for clinical trials.
- The clinical features of many of these conditions differ between adults and children. Identifying the characterizing symptoms in children is important to determine enrollment in clinical trials.
- Few effective, disease-specific treatments are available for many of these conditions, especially for severe and refractory cases. Future trials should target patient populations resistant to standard therapies.
- These conditions carry a potentially major financial burden on patients and their families, making identifying new, effective, and affordable treatment options a priority.
Meetings that bring together all stakeholders to evaluate the state of the science and outline future directions for the development of safe and effective treatments are critical to improving the lives of those affected by these conditions. We are grateful to the AGA for sponsoring this important meeting.
August 18, 2017 – Based on accounts from 28 individuals with fecal incontinence (FI) who participated in online focus groups and 186 individuals with FI who completed an online survey, researchers concluded that inclusion criteria for clinical trials should specify a minimum frequency of FI. Most patients would require a 75-80% reduction in FI frequency to call a treatment successful, but young adults and those with more severe FI would accept at least a 50% reduction as meaningful. “Adequate relief” was acceptable to 78% of the survey participants.
Randomized controlled trials for treatments of FI are difficult to compare because case definitions and study endpoints often vary. Input from patients about the desired outcomes of potential treatments helps researchers standardize the necessary endpoints of clinical trials and design future studies that will adequately address patient needs.
Source: Heymen S, et al. Neurogastroenterol Motil. May 2017.
August 2, 2017 – A study of 50 patients with laryngopharyngeal reflux (LPR) and 50 controls with no history of LPR and nasal disease concluded that LPR has a negative effect on nasal resistance and nasal congestion in affected individuals. However, treatment over 12 weeks with oral antireflux medication was associated with improved nasal findings.
Source: Dagli E, et al. JAMA Otolaryngol Head Neck Surg. March 2017.
July 20, 2017 – Fewer than 30% of women with fecal incontinence (FI) seek care for their condition. In order to better understand factors that may prevent or delay care seeking, researchers recruited 39 women with FI to participate in focus groups and interviews. A total of 12 barriers to seeking care for FI were identified encompassing three overarching themes: understanding of FI and its treatments, the relationship between perceptions of self and FI, and interactions with the healthcare system.
Care-seeking barriers in FI are similar to those described for urinary incontinence, including lack of knowledge about treatment; feelings of embarrassment, isolation, and stigma; and access limitations, with the notable addition of lack of knowledge that FI is a medical condition experienced by others. The authors argue that information about FI prevalence and treatability should be included in any efforts to promote access to effective treatments.
Source: Brown HW, et al. Int Urogynecol J. April 2017.
July 7, 2017 – Results of an online survey of 1,924 individuals with a history of gastrointestinal (GI) symptoms found that more than one third (43%) had no medical diagnosis of irritable bowel syndrome (IBS) despite meeting diagnostic criteria for the condition.
Of those that had previously been diagnosed with IBS, 45% had been diagnosed by a gastroenterologist while 42% obtained their diagnosis from their primary care physician. Over one quarter (26%) and one third (43%) of diagnosed and undiagnosed individuals, respectively, were not receiving any treatment for their GI symptoms. Among those who were receiving treatment, 40% received IBS-related treatment from their primary care physician.
Source: Sayuk GS, et al. Am J Gastroenterol. January 2017.
June 21, 2017 – A systematic review of existing data from 21 randomized controlled clinical trials assessing the efficacy and safety of a particular class of drugs (5-hydroxytryptamine 3 receptor antagonists) in adults with non-constipated irritable bowel syndrome (IBS) or diarrhea predominant IBS (IBS-D) against placebo or other conventional treatment concluded that this class of drugs is effective in improving symptoms of non-constipated IBS and IBS-D, including abdominal pain and stool consistency. Drugs of this class include ramosetron, cilansetron, odansetron, and alosetron.
The most common adverse effect was constipation, which was likelier in those with non-constipated IBS after treatment than in those with IBS-D only. The systematic review found rare serious adverse events.
Source: Zheng Y, et al. PLOS One. March 2017.
June 12, 2017 – In May, IFFGD joined with clinicians, scientists, and others at the 2017 Digestive Disease Week (DDW) international meeting in Chicago, IL where the latest research findings in the field of digestive health were presented. Here are brief summaries from the meeting of findings relevant to the functional gastrointestinal and motility disorders (FGIMDs) community. Research presented at the meeting is considered preliminary until published in a peer-reviewed journal.
Positive results were presented about a number of therapies for treating FGIMDs, including: the injectable drug relamorelin was better than placebo for treating adult patients with diabetic gastroparesis; gastric electrical stimulation (GES) therapy improved symptoms of gastroparesis; a medical food containing caraway oil and L-menthol used in addition to standard drug therapies improved symptoms of functional dyspepsia; magnetic sphincter augmentation was more effective than PPI therapy for treating troublesome regurgitation in patients with gastroesophageal reflux disease (GERD);a low FODMAP diet approach was effective for some individuals with irritable bowel syndrome (IBS) when administered and carried out under the guidance of an expert nutritionist; pelvic floor physical therapy helped to reduce episodes of fecal incontinence in children with pelvic floor dyssynergia; diaphragmatic breathing exercises helped improve belching severity in GERD patients with belching symptoms.
Studies looked at factors influencing quality of life, symptom severity, and economic impact of FGIMDs, including: functional dyspepsia is associated with significant economic costs among patients in Japan; greater severity of nausea, vomiting, and abdominal pain symptoms is associated with gastric retention in gastroparesis patients; sex differences exist in how fecal incontinence is experienced by individuals; sleep disorders, and sleep related anxiety and depression contributed to the severity of symptoms in patients with chronic constipation in China; IBS patients in Canada suffer from multiple symptoms that they do not feel are under control; diarrhea predominant IBS (IBS-D) poses a significant impact on patient quality of life, medication use, and the desire for more and better treatments in patients who participated in a multi-country survey.
Through innovative research the FGIMD community can achieve better understanding, faster and more accurate diagnoses, better treatment options, and ultimately, better health outcomes and improved quality of life. You can help support these efforts with a tax-deductible donation to IFFGD at ffgd.org/make-a-donation.
June 2, 2017 – An advisory panel from the US Food and Drug Administration (FDA) warned against the use of over-the-counter (OTC) products combining an analgesic (specifically, aspirin and acetaminophen) with antacids for the relief of “minor aches and pains associated with heartburn, sour stomach, acid indigestion, fullness, belching, gas, or nausea.” In response to reports of serious bleeding events associated with the use of aspirin-antacid combination products, the FDA released a Drug Safety Communication in 2016 warning about the risk of bleeding and added the risk to all OTC product labels containing aspirin or other nonsteroidal anti-inflammatory drugs.
Source: FDA Briefing Document. (Accessed 4/14/2017)
May 17, 2017 – Health Canada, the Federal department of Canada responsible for helping Canadians maintain and improve their health, approved eluxadoline (Viberzi) for the treatment of adults with diarrhea predominant irritable bowel syndrome (IBS-D).
Eluxadoline is also available as Viberzi in the US and is approved in Europe as Truberzi.
May 13, 2017 – Results from a study by researchers at UCLA of 29 adults with irritable bowel syndrome (IBS) and 23 healthy control subjects confirm previous reports of gut microbiome-based IBS subgroups and identify for the first time brain structural alterations associated with these subgroups. The findings provide preliminary evidence for the involvement of specific microbes and their predicted metabolites in correlations between gut microbial measures and structural brain signatures in IBS.
The results suggest that identifying IBS subgroups based on gut microbiota, their related metabolomics profiles, and corresponding brain signatures is likely to play an important role in optimizing therapies in IBS.
Source: Labus JS, et al. Microbiome. May 2017.
May 12, 2017 – A study of 76 adults seen in a GI motility clinic found that taste and smell disturbances were higher in patients with gastroparesis and/or gastroesophageal reflux disease (GERD) compared to healthy controls. While no causal relationship was assessed, taste and smell abnormalities were associated with increasing symptom severity, and may contribute to the food intolerances that many of these patients experience. Further investigations are needed to better understand this association and its possible impact on quality of life among patients with these GI disorders.
Source: Kabadi A, et al. J Neurogastroenterol Motil. February 2017.
April 25, 2017 – Among 132 individuals diagnosed with gastroesophageal reflux disease (GERD), those experiencing the functional dyspepsia symptoms of early satiation (feeling of fullness) and vomiting were found to have reduced responsiveness to standard therapy with proton pump inhibitors (PPIs). Results of this study may help clinicians better identify PPI-resistance in patients with GERD.
Source: D’Alessandro A, et al. UEG Journal. February 2017.
April 13, 2017 – Researchers at the University of Chicago caution that people who adhere to a gluten-free diet may be at risk for increased exposure to toxic metals due to changes in their diet. In a small study examining existing data from the US National Health and Nutrition Examination Survey, the researchers detected an increase in heavy-metal blood or urine levels among people following a gluten-free diet compared with people not following it. Many gluten-free diets include foods that have high concentrations of metals, such as fish and rice. While the levels found in the study were generally below toxic thresholds, further research is necessary to determine the long-term effects of accumulation of these elements in persons on the diet.
Source: Bulka CM, et al. Epidemiology. May 2017.
March 23, 2017 – By using a novel technique to evaluate the gut microbiota (intestinal microorganisms) present in 139 adult patients with irritable bowel syndrome (IBS) and 56 healthy controls, researchers were able to identify a distinct microbiota signature associated with severity of IBS symptoms. Notably, patients with severe IBS also had reduced microbiome species richness compared with healthy individuals and IBS patients with mild/moderate symptoms.
This microbiome signature may be used to explore other clinically relevant features of IBS and help researchers and clinicians develop new treatment pathways.
Source: Tap J, et al. Gastroenterology. January 2017.
FDA Warns about Increased Risk of Serious Pancreatitis with IBS drug eluxadoline (Viberzi) in Patients Without a Gallbladder
March 15, 2017 – The U.S. Food and Drug Administration (FDA) has issued a warning that eluxadoline (Viberzi), a medicine used to treat irritable bowel syndrome with diarrhea (IBS-D), should not be used in patients who do not have a gallbladder. An FDA review found these patients have an increased risk of developing serious pancreatitis that could result in hospitalization or death. Read more»
Source: FDA.gov Drug Safety News (Accessed 03/15/17)
March 10, 2017 – More than half of children in an observational study of 83 children newly diagnosed with irritable bowel syndrome (IBS) were found to show spontaneous symptom resolution over a period of 24 months regardless of sex, age, effect of symptoms on daily activities, and IBS subtype.
Very little is currently known about the natural history of IBS in children. Additional studies looking at IBS prevalence, symptom burden, and the safety and efficacy of treatments in children are needed.
Source: Giannetti E, et al. J Pediatr. [Epub ahead of print].
February 27, 2017 – Consumption of red meat, particularly when unprocessed, was associated with an increased risk of diverticulitis in a research study involving 46,461 adult men. The risk of diverticulitis progressively increased after just one serving of unprocessed red meat per week but plateaued after six servings per week. Higher consumption of poultry or fish was not associated with risk for diverticulitis, and substituting fish or poultry for one serving of unprocessed red meat per day resulted in a decrease in the risk for diverticulitis.
While the mechanisms behind this association are not entirely understood, the relationship between unprocessed red meat and diverticulitis in men found here may provide practical guidance for individuals at risk for the condition.
Source: Cao Y, et al. Gut. 2017 [Epub ahead of print].
February 20, 2017 – The US Food and Drug Administration (FDA) approved a new, lower dose of linaclotide (Linzess) for the treatment of chronic idiopathic constipation (CIC) in adults, which will offer clinicians more flexibility to prescribe based on individual patient need and tolerability. A range of FDA approved doses available to clinicians is important in the treatment of diverse patient populations.
Source: FDA Approvals. Medscape.com. (Accessed January 28, 2017).
February 20, 2017 – A clinical research study found that uncertain diagnoses and vague explanations to patients could contribute to unnecessary invasive tests as well as suboptimal care in patients with functional gastrointestinal (GI) disorders, suggesting that patient care benefits from clear explanations of functional GI disorders and their chronic recurrent nature, as well as a clear explanation for why further testing may or may not be needed.
The study reviewed medical file documentation from 207 patients with either a “functional” GI disorder (such as irritable bowel syndrome) or an “organic” GI disease (such as inflammatory bowel disease) that were referred to a highly specialized (tertiary) medical center GI unit in Australia.
Source: Linedale EC, et al. Clin Gastroenterol Hepatol. December 2016.
January 27, 2017 – A research survey of 1,423 adults diagnosed with gastroparesis describes the burdens, concerns, and effects on quality of life imposed on people living with the chronic condition. The peer-reviewed journal, Digestive Diseases and Sciences, published results of the Gastroparesis Community Survey conducted by the International Foundation for Functional Gastrointestinal Disorders (IFFGD) in collaboration with clinical researchers from Temple University School of Medicine. View a survey report on this IFFGD web page»
Source: Daohai Y, et al. Dig Dis Sci. January 2017.
January 19, 2017 – The U.S. Food and Drug Administration (FDA) today approved the drug plecanatide (Trulance) for the treatment of chronic idiopathic constipation (CIC) in adult patients aged 18 and over. In two 12-week clinical trials involving 1,775 adults with CIC to establish safety and efficacy, participants receiving plecanatide were more likely to experience improvement in the frequency of complete spontaneous bowel movements than those receiving placebo, and also had improvements in stool frequency and consistency and straining. The most serious and severe side-effect was diarrhea. The drug should not be used in children less than 6 years of age due to the risk of serious dehydration, and should be avoided in patients 6 to 18 years of age as the safety and effectiveness of plecanatide (Trulance) have not been established in patients less than 18 years of age. Trulance should not be used in patients with known or suspected mechanical gastrointestinal obstruction.
Source: FDA News Release. (Accessed January 19, 2017).
January 12, 2017 – Based on an in-depth review of published research, a committee report from the National Academies of Sciences, Engineering, and Medicine (National Academies) found that evidence on the effectiveness of marijuana and/or its constituents for the treatment of irritable bowel syndrome (IBS) is insufficient. The committee concluded that trials that evaluate patient-reported outcomes are needed to further understand the clinical effects in patients with IBS. The full report looked at health effects in many conditions and issues.
December 29, 2016 – Findings from a study of 29 adults with irritable bowel syndrome (IBS) and 29 healthy controls suggest that an increased sensitivity (visceral hypersensitivity) of the colon to the sensation of distension – rather than excessive gas production – produces symptoms related to ingestion of poorly absorbed, fermentable carbohydrates (e.g., FODMAPs) in patients with IBS. The authors conclude that this may help explain the reason some IBS patients report symptoms after eating FODMAP-containing foods, and relief of symptoms when following a low FODMAP diet. The study patients experiencing symptoms did not have greater gas production or distension than healthy controls. They were, however, more sensitive to stimulation of the bowel and their symptoms correlated to the amount of gas produced.
Source: Major G, et al. Gastroenterology. 2016 [Epub ahead of print].
December 28, 2016 – The National Institutes of Health (NIH), the center of all federally-funded biomedical research in the US, has established a Nutrition Research Task Force to accelerate progress in nutrition research across all NIH agencies, including the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and guide the development of the first NIH-wide strategic plan for nutrition research for the next 10 years. This multidisciplinary task force is intended to complement and enhance ongoing research efforts across the NIH on diseases and conditions affected by nutrition, including diabetes, cancer, obesity, heart disease, and digestive disorders, as well as general health, and spearhead new research initiatives.
Source: National Institutes of Health (NIH.gov). News Releases. (Accessed December 28, 2016)
December 28, 2016 – Among 81 children 8 to 18 years-of-age with a diagnosis of inflammatory bowel disease (62 Crohn’s disease, 19 ulcerative colitis), 26% were found to have concurrent functional abdominal pain syndrome (FAPS). Children in this overlap IBD-FAPS population had significantly higher anxiety and depression scores and were found to have a lower quality of life than individuals with IBD without FAPS. Identification of children predisposed to overlap IBD-FAPS may help clinicians implement strategies to improve their symptoms and quality of life.
Source: Watson KL Jr., et al. J Pediatr Gastroenterol Nutr. 2016 [Epub ahead of print].
December 28, 2016 – In a European study of children and adolescents (ages 6 to 17 years) migraine headache was found to be associated with several functional gastrointestinal (GI) conditions, including irritable bowel syndrome (IBS), functional dyspepsia, and abdominal migraine. No association was found between tension-type headache and functional GI disorders in this population. Observation of a link between these conditions may help doctors better diagnose and manage these conditions in the future.
Source: Le Gal J, et al. Lancet. October 2016.
December 25, 2016 – Researchers in a multicenter study found that genetic variation in the sucrase-isomaltase gene is associated with an increased risk for irritable bowel syndrome (IBS). The gene variants also occur in congenital sucrase-isomaltase deficiency (CSID), a rare condition that affects a person’s ability to digest certain simple sugars (carbohydrates), resulting in symptoms. The gene mutations were found to be more common among individuals with IBS, particularly those with diarrhea predominant IBS (IBS-D), compared to controls or those from the general population. Advances in characterizing genetic variants can help improve understanding of how best to target treatment options individually for patients.
Source: Henström M, et al. Gut. November 2016.
December 25, 2016 – Long-term use of proton pump inhibitors (PPIs) or histamine-2 receptor antagonists (H2RAs) to suppress gastric acid production increases the risk for developing iron deficiency according to a community study. Increased risk was associated with dose and duration (2 years or more) of use. While the risk is not high, the researchers recommend that clinicians be vigilant when prescribing these medications, and use the lowest effective dose.
Source: Lam JR, et al. Gastroenterology. 2016 [Epub ahead of print].
Prescription drug-taking tips from the FDA
- Do not stop taking your prescription drug without talking to your healthcare professional
- Discuss any questions or concerns about your prescription drug with your healthcare professional
- Use the lowest dose and shortest duration of therapy appropriate to the condition being treated
December 22, 2016 – Results from a Phase 2b clinical trial to study an investigational linaclotide colonic release-2 (CR2) formulation in adult patients with irritable bowel syndrome with constipation (IBS-C) showed that CR2 was more effective than placebo in improving abdominal pain and other abdominal symptoms, such as bloating and discomfort, with no apparent effect on bowel movement function. These findings support further investigation of CR2 in specific GI indications where patients experience abdominal pain but are not necessarily constipated, such as IBS-Mixed, IBS with diarrhea, ulcerative colitis and diverticulitis.
In another Phase 2b study, positive results were reported for the investigational linaclotide colonic release-1 (CR1) formulation in adults patients with IBS-C. Linaclotide CR1 is designed to provide targeted delivery of linaclotide to intestinal areas. The new formulation of linaclotide may produce additional relief of abdominal pain in patients with IBS-C.
Additional clinical trials to study the new formulations are required before FDA or other regulatory approval may be requested.
Source: Allergan and Ironwood News Releases. December 22, 2016
December 19, 2016 – The Japanese Ministry of Health, Labor and Welfare approved linaclotide (Linzess) as prescription treatment for adults with irritable bowel syndrome with constipation (IBS-C) in Japan. Ironwood Pharmaceuticals and its partner, Astellas Pharma anticipate that the drug will be available in the first half of 2017.
December 15, 2016 – The following are a selection of research studies presented as abstracts at the August 2016 Federation of Neurogastroenterology and Motility (FNM) meeting in San Francisco, CA, an international conference for medical professionals.
The data and conclusions presented here should be considered preliminary until published in a peer-reviewed journal.
- A double-blind, controlled, cross-over study of 16 patients with clinically suspected rumination syndrome concluded that the drug baclofen—through its effect on lower esophageal sphincter pressure—reduced symptoms more effectively than placebo.
- Motility changes were observed and measured in a study that looked at 41 patients suffering chronic constipation with fecal evacuation disorders whose symptoms improved after biofeedback therapy (two sessions per day for 2 weeks).
- A study of 101 adult patients with cyclic vomiting syndrome (CVS) found that these individuals have poor health related quality of life relative to the general US population. Major factors driving the poor quality of life scores in this population included anxiety and depression. The authors urge a biopsychosocial care model for CVS patients with co-existing factors such as anxiety, depression, and pain.
- A study of 16 patients with irritable bowel syndrome (IBS) and 20 healthy controls given infusions of different FODMAP food components found fructans (a polymer of the frucost molecule) compared to glucose induced higher symptom ratings of cramps and flatulence in healthy controls and especially in individuals with IBS. Fructans are found in foods such as agave, artichokes, asparagus, leeks, garlic, onions, jicama, and wheat.
- A study of 516 patients with gastroparesis and 195 with chronic unexplained nausea and vomiting (CUNV) concluded that abdominal pain and overlapping non-abdominal pain syndromes (migraine headache, endometriosis, fibromyalgia, chronic fatigue syndrome, and interstitial cystitis) were important burdens for patients. Patients with co-existing migraine headaches had the highest disease burden scores. The findings draw attention to the need for a multidisciplinary approach to the management of pain for these patients.
December 12, 2016 – On December 9, 2016 Synergy Pharmaceuticals announced results from the first of two randomized, double-blind, placebo-controlled Phase 3 clinical trials evaluating the efficacy and safety of the new drug, plecanatide, for the treatment of irritable bowel syndrome with constipation (IBS-C). The drug was more effective than placebo in the number of complete spontaneous bowel movements and relieving abdominal pain in patients over a trial period of 12 weeks. The study involved 1,135 adult patients with IBS-C. The most common adverse event was diarrhea, which occurred in less than 4% of patients.
November 29, 2016 – The following are a selection of research studies presented as abstracts at the October 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.
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.
Drug Development Conference Addresses Current Challenges and Emerging Solutions in Upper GI Disorders
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 IFFGD and other 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 meeting focused on 4 disease states: reflux disease (GERD) that is incompletely responsive to acid inhibition, eosinophilic esophagitis (EoE), gastroparesis (Gp), and functional dyspepsia (FD). These disorders cause significant suffering worldwide and limited treatment options are available particularly in the USA. 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.
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.
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.
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.
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.
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.
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.
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.
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.
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 5 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 (51%), 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 dyspepsia 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.
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.
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.
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.
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. They suggest that individuals with IBS might benefit from screening and possible supplementation.
Source: Tazzyman S, et al. BMJ Open Gastroenterol. November 2015.
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.
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)
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.
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.
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.
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.
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.
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.
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.
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.
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.