Glutamine for the Treatment of Patients With Irritable Bowel Syndrome (AT005291)
Recruitment status was: Recruiting
Irritable bowel syndrome (IBS) is a common gastrointestinal disorder that is estimated to affect 20% of the US population. IBS patients have significantly decreased quality of life and utilize large amounts of health care resources. IBS patients suffer from chronic abdominal pain associated with diarrhea, constipation, and/or bloating. Several recent studies have shown that diarrhea-predominant IBS (D-IBS) patients have increased intestinal permeability that may lead to chronic gastrointestinal symptoms.
Previously, it has been well established that deficiencies in glutamine may lead to increased membrane permeability and supplementation with glutamine can restore intestinal membrane permeability. The investigators hypothesize that oral glutamine supplementation will improve the IBS Symptom Severity Scale and restore intestinal membrane permeability in diarrhea-predominant IBS patients. The investigators propose to conduct a randomized, double-blind, placebo-controlled clinical trial studying glutamine compared to placebo for 8 weeks in 100 diarrhea-predominant IBS patients. This will lead to the following specific aims: Specific Aim 1: To determine if oral glutamine supplementation will improve the IBS Symptom Severity Scale in IBS patients. To accomplish this aim, the investigators will measure the change in the IBS Symptom Severity Scale following treatment with either oral glutamine supplementation or placebo. The primary outcome measure will be an improvement or clinically significant response to treatment of ≥50 from the baseline score on the IBS Symptom Severity Scale. Specific Aim 2: To determine if oral glutamine supplementation will restore intestinal permeability in IBS patients. To accomplish this aim, the investigators will measure the change in the intestinal permeability following treatment with either oral glutamine supplementation or placebo.
|Irritable Bowel Syndrome||Dietary Supplement: Glutamine Supplementation Dietary Supplement: Placebo Drug: Glutamine||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||Randomized, Placebo-Controlled Trial of Glutamine for the Treatment of Patients With Irritable Bowel Syndrome|
- Change in the Irritable Bowel Symptom Severity Scale [ Time Frame: baseline and at 2, 4, 6, and 8 weeks following therapy ]The primary outcome measure will be a change in the Irritable Bowel Symptom Severity Scale from baseline to 2, 4, 6, and 8 weeks following therapy.
- Change in Intestinal Permeability [ Time Frame: baseline and 2, 4, 6, and 8 weeks following therapy ]The secondary outcome measure will be a change in intestinal permeability from base to 2, 4, 6, and 8 weeks following therapy.
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Glutamine supplementation
Dietary Supplement: Glutamine Supplementation
Other Name: L-GlutamineDrug: Glutamine
Placebo Comparator: Placebo
Whey protein powder
Dietary Supplement: Placebo
Other Name: sugar pill
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01414244
|Contact: QiQi Zhou, M.D., Ph.Demail@example.com|
|United States, Texas|
|University of Texas Medical Branch||Recruiting|
|Galveston, Texas, United States, 77550|
|Contact: QiQi Zhou, M.D., Ph.D. 614-271-7118 firstname.lastname@example.org|
|Principal Investigator:||QiQi Zhou||University of Texas, Galveston|