Glutamine for the Treatment of Patients With Irritable Bowel Syndrome

Study Overview
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Brief Summary
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New and effective treatments are needed for patients with post-infectious irritable bowel syndrome (PI-IBS). We conducted a randomized, placebo-controlled trial to assess the efficacy and safety of glutamine, an abundant amino acid in the body and the principal fuel for enterocytes, in patients who developed diarrhea-predominant irritable bowel syndrome with increased intestinal permeability following an enteric infection.

Detailed Description
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In a double-blind trial, eligible adults with post-infectious IBS with increased intestinal permeability were randomly assigned to receive either glutamine (5 g three times daily) or placebo for eight weeks. The primary end point was the proportion of patients who had a reduction of ≥50 on the Irritable Bowel Severity Scoring System (IBS-SS).

Official Title
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Randomized, Placebo-Controlled Trial of Glutamine for the Treatment of Patients With Irritable Bowel Syndrome

Conditions
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Diarrhea-Predominant Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: Glutamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: men and women age 18-72 years old who developed post-infectious diarrhea-predominant IBS (D-IBS) increased intestinal permeability on Lactulose/Mannitol permeability test able and willing to cooperate with the study *absence of alcohol or NSAIDs ingestion for 2 weeks prior to inclusion into study and throughout the study duration Exclusion Criteria: current participation in another research protocol or unable to give informed consent women with a positive urine pregnancy test or breastfeeding history of inflammatory bowel disease, lactose intolerance, and/or celiac sprue + hydrogen breath test for bacterial overgrowth + antiendomysial antibody titer use of nonsteroidal antinflammatory drug(NSAIDs) 2 weeks before or during the study known allergy to glutamine abdominal surgery except for removal of gallbladder, uterus, or appendix Abnormal blood urea nitrogen(BUN) and/or creatinine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glutamine supplementation<br>Glutamine | Drug: Glutamine<br>* Drug<br>* Other names: L-Glutamine;|
| Placebo Comparator: Placebo<br>Whey protein powder | Drug: Glutamine<br>* Drug<br>* Other names: L-Glutamine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Irritable Bowel Symptom Severity Scale | The primary outcome measure will be a change in the Irritable Bowel Symptom Severity Scale (IBS-SS) from baseline to 8 weeks at the conclusion of therapy. The IBS-SS scale ranges from 0 to 500 (worst). A decrease in 50 or greater in the IBS-SS is considered a positive response. | baseline and 8 weeks following therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intestinal Permeability | The secondary outcome measure will be a change in intestinal permeability from baseline to 8 weeks at the conclusion of therapy. Intestinal permeability is measured by the urinary lactulose/mannitol ratio following ingestion of a solution of lactulose and mannitol. | baseline and 8 weeks following therapy | 
| Stool Frequency | Baseline and 8 week at the conclusion of therapy | Baseline and 8 weeks following therapy | 
| Stool Consistency | Bristol Stool Scale The Bristol Stool Scale characterizes stool characteristics and ranges from a minimum score of 1 with depicts hard or constipated stool to a maximum score of 7 which is watery or diarrheal stools. In this trial, stool that is less than 7 is better and depicts a good outcome. | Baseline and 8 weeks following therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Irritable Bowel Syndrome, Glutamine, Intestinal Permeability