Glutamine for the Treatment of Patients With Irritable Bowel Syndrome

Phase 2

Completed

• Conditions: Diarrhea-Predominant Irritable Bowel Syndrome
• Interventions: Drug: Glutamine

• Registration Number: NCT01414244
• Lead Sponsor: Tulane University

Brief Summary

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

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).

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-07-29
• Study First Submitted QC: 2011-08-10
• Study First Posted: 2011-08-11
• Primary Completion: 2015-12-30
• Study Completion: 2015-12-30
• Results First Submitted: 2017-04-10
• Status Verified: 2017-08
• Results First Submitted QC: 2017-08-07
• Last Update Submitted: 2017-08-07
• Results First Posted: 2017-08-09
• Last Update Posted: 2017-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glutamine supplementation	Glutamine	Glutamine
Placebo	Glutamine	Whey protein powder

Primary Outcome Measures

Name	Time	Method
Change in the Irritable Bowel Symptom Severity Scale	baseline and 8 weeks following therapy	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.

Secondary Outcome Measures

Name	Time	Method
Intestinal Permeability	baseline and 8 weeks following therapy	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.
Stool Frequency	Baseline and 8 weeks following therapy	Baseline and 8 week at the conclusion of therapy
Stool Consistency	Baseline and 8 weeks following therapy	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.

Trial Locations

Locations (1)

Tulane University School of Medicine; 🇺🇸 New Orleans, Louisiana, United States