A clinical study or trial is a research study to answer specific questions about new therapies or new ways of using known treatments. Clinical studies/trials test potential treatments in human volunteers to see if they should be approved for wider use in the general population.

Why Participate in a Clinical Trial?
Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research. (Find out more including answers to frequently asked questions in this Guide to Randomized Clinical Trials.)


Irritable Bowel Syndrome (IBS)

Participants Sought for a Multicenter, Randomized, Double-blind, Placebo-controlled Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7 to 17 Years, with Irritable Bowel Syndrome with Constipation (IBS-C)


Purpose of Study
: The purpose of this study is to evaluate the safety and efficacy of linaclotide for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C), in children ages 7-17 years.

This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Patients age 7-11 will receive oral liquid or oral solid capsule and patients 12-17 will receive solid oral capsule formulation. Children ages 7-11 years meeting the entry criteria will be randomized to 1 of 3 doses of linaclotide or placebo for 4 weeks. Children ages 12-17 years meeting the entry criteria will be randomized to 1 of 4 doses of linaclotide or placebo for 4 weeks.

This 4-week study will assess the effects of linaclotide on bowel movement frequency, as well as other bowel symptoms of IBS-C.

Sponsor: Forest Laboratories

Study Population: Male and female patients ages 7 years to 17 years who meet inclusion criteria, including Rome III symptom criteria for child/adolescent IBS and for modified Rome III criteria for child/adolescent functional constipation.

Phase: Phase 2

Contact: For more information visit www.marco-polostudies.com or phone 888-609-3456.

Verified June 2016

Participants Sought for a Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 6 to 17 Years, Who Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation (FC)


Purpose of study
:The purpose of this study is to evaluate the safety and efficacy of linaclotide for the treatment of functional constipation (FC), in children, ages 6-17 years. This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Patients age 6-11 will receive oral liquid formulation and patients 12-17 will receive solid oral capsule or liquid oral solution.

Children ages 6-11 years meeting the entry criteria will be randomized to 1 of 3 doses of linaclotide or placebo for 4 weeks. Children ages 12-17 years meeting the entry criteria will be randomized to 1 of 4 doses of linaclotide or placebo for 4 weeks. This 4-week study will assess the effects of linaclotide on bowel movement frequency, as well as other bowel symptoms of FC.

Sponsor: Forest Laboratories

Study Population: Male and female patients ages 6 years to 17 years who meet inclusion criteria, including Rome III symptom criteria for child/adolescent functional constipation (FC).

Phase: Phase 2

Contact: For more information visit www.marco-polostudies.com or phone 888-609-3456.

Verified June 2016

Seeking Women Who are Breastfeeding or Pumping and are Taking Linaclotide for IBS-C or CIC

Purpose of study: This study will determine the amount of linaclotide in breast milk after once daily doses of the drug over 4 consecutive days.

Sponsor: Forest Laboratories

Participation: Eligible female patients currently taking linaclotide for constipation predominant irritable bowel syndrome (IBS-C) or chronic idiopathic constipation (CIC) who have been actively breastfeeding or pumping for at least 4 weeks.

Phase: Phase 1

Location: Iowa City, Iowa

Contacts: Sandra Beaird, Pharm.D. Phone: 1-800-678-1605, ext 66297; Be sure to refer to this study by its ClinicalTrials.gov identifier: NCT02220348

Verified June 2016

 

Short Bowel Syndrome (SBS)

Participants Sought for a SBS Research Study for Children Up To 17 Years of Age on Parenteral Nutrition

Purpose of Study: Short bowel syndrome (SBS) is a rare disorder. This 24-week, double-blind study is evaluating the safety and effectiveness of teduglutide in children up to the age of 17 with SBS. Teduglutide is currently an approved medicine for adults with SBS. The aim of the study is to increase absorption of nutrients which may result in decreased parenteral support.

Sponsor: Shire

Study Population: The study is in a pediatric patient population of males and females with SBS dependent on Parenteral Support - the upper age limit is 17 years of age. The study will take place in the US, Canada, Finland, Italy, Belgium, UK, France, and Germany.

Phase: Phase 3

Contact: Email: This email address is being protected from spambots. You need JavaScript enabled to view it.; be sure to refer to this study by its ClinicalTrials.gov identifier: NCT02682381

Verified November 2016

Patients with SBS Sought for Long-term Study

Purpose of Study: This global clinical study has begun enrolling patients with short bowel syndrome (SBS) in order to provide additional long-term data on safety of teduglutide and on the natural history of SBS in patients in routine, real world settings. The information gathered is intended to assist health care providers in optimizing their clinical decisionmaking in managing SBS patients.

Enrollment will include SBS patients treated and not treated with teduglutide.

Sponsor: Shire

Study Population: Male and female patients of any age with a diagnosis of SBS, including those who have never taken teduglutide, as well those who have or are using teduglutide.

Study Follow-up Duration: 10 years

Contact: Email: This email address is being protected from spambots. You need JavaScript enabled to view it.; be sure to refer to this study by its ClinicalTrials.gov identifier: NCT01990040

Verified June 2016

Study of Oral Budesonide for Treatment of EoE

Purpose of Study: A Phase 3, randomized, double-blind, placebo-controlled trial to study safety and efficacy of the drug oral budesonide suspension (OBS) in adolescent and adult subjects (11 to 55 years of age, inclusive) with eosinophilic esophagitis (EoE), which involves a planned 3-6 week screening period, a 16 week treatment period, and a 4 week follow-up period.

Sponsor: Shire

Study Population: Male and female patients with EoE aged 11 to 55 who meet inclusion criteria.

Phase: Phase 3

Contact: Email: This email address is being protected from spambots. You need JavaScript enabled to view it.; be sure to refer to this study by its ClinicalTrials.gov identifier: NCT02605837

Verified November 2016

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Research Awards
2013 Award Recipients
Enrico Corazziari, MD
Jan Tack, MD, PhD
Gary Mawe, PhD
Ashley Blackshaw, PhD
Carlo Di Lorenzo, MD
Niranga Manjuri Devanarayana, MD
Report from Lukas Van Oudenhove, PhD: Solving the Biopsychosocial Puzzle in Functional Dyspepsia
Muriel Larauche, PhD
2011 Award Recipients
Report from Ronnie Fass, MD: Sleep and Gastroesophageal Reflux Disease (GERD)
Million Mulugeta, PhD
Adrian Miranda, MD
Samuel Nurko, MD
Sudarshan Jadcherla, MD
Shaman Rajindrajith, MD
2009 Award Recipients
Satish Rao, MD
Emeran Mayer, MD
Javier Santos, MD
Report from Martin Storr, MD, PhD: Functional Gastrointestinal Disorders: New Insights in Enteric Regulation
Report From Miguel Saps, MD: Functional Abdominal Pain in Children and Adolescents
2007 Award Recipients
Report from Bruce D. Naliboff, PhD: Symptom Based Psychology for Functional Gastrointestinal Disorders
Report from Magnus Simrén, MD, PhD: Irritable Bowel Syndrome: Searching for Underlying Causes
Report from Brennan M. R. Spiegel, MD, MSHS: Diagnostic Testing in Irritable Bowel Syndrome: Theory vs. Reality
Report from Sylvie Bradesi, PhD: Role of the Central Immune System in Functional Disorders
Paul E. Hyman, MD
Report from Miranda A. L. van Tilburg, PhD: Home Based Guided Imagery to Treat Pediatric Functional Abdominal Pain
Report from Fernando Azpiroz, MD, PhD: Understanding Intestinal Gas
2005 Award Recipients
Report from Yvette Tache, PhD: Stress and Irritable Bowel Syndrome: Unraveling the Code
Report from Shaheen Hamdy, MRCP, PhD: Adult Neurogenic Dysphagia -- Disorders and Conditions that Disrupt Swallowing
Report from Michael A. Pezzone, MD, PhD: Chronic Pelvic Pain and the Overlap of Pelvic Pain Disorders
Report from Bridget R. Southwell, PhD: Research into Treatment-Resistant Constipation in Children
Report from Rachel Rosen, MD, MPH: Symptoms Arising from Non-Acid Reflux in Children
2003 Award Recipients
Report from William E. Whitehead, PhD: Summary of Clinical Research Activities
Jyoti N. Sengupta, PhD
Report from Caroline Elder Danda, PhD: Biopsychosocial Perspectives on Assessment and Treatment
Report from Terry Buchmiller-Crair, MD: Using the Fetal Gastrointestinal Tract to Overcome Neonatal Disease
Report from Dan L. Dumitrascu, MD, PhD: The Psychosocial Adjustment to Illness in Irritable Bowel Syndrome
Report from Klaus Bielefeldt, MD, PhD: Understanding Pain and Discomfort in Functional GI Disorders
Research Grants
IFFGD Competitive Grants
2014 IFFGD Idiopathic Gastroparesis Research Grants
Leo Cheng, PhD
Braden Kuo, MD, MSc
Richard McCallum, MD
2008 IFFGD Competitive Research Grants
IFFGD Noncompetitive Grants
Other Research Grant Opportunities
Funding Research
Need for Funding Research
How to Make a Difference
The State of Research at NIH & NIDDK
Clinical Trials & Studies
IBS Studies
Guide to Randomized Clinical Trials
Industry Sponsored Clinical Trials and Studies
NIH/Other Sponsored Clinical Trials and Studies

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