Clinical Trials Directory

Trials / Completed

CompletedNCT01414244

Glutamine for the Treatment of Patients With Irritable Bowel Syndrome

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
106 (actual)
Sponsor
Tulane University · Academic / Other
Sex
All
Age
18 Years – 72 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
DRUGGlutamineDrug

Timeline

Start date
2010-11-01
Primary completion
2015-12-30
Completion
2015-12-30
First posted
2011-08-11
Last updated
2017-08-09
Results posted
2017-08-09

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01414244. Inclusion in this directory is not an endorsement.