Glutamine for the Treatment of Patients With Irritable Bowel Syndrome (AT005291)

Tulane University

Status and phase: Completed; Phase 2

Conditions: Diarrhea-Predominant Irritable Bowel Syndrome

Treatments: Drug: Glutamine

Study type: Interventional

Funder types: Other

Identifiers

NCT01414244

11-271

Details and patient eligibility

About

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.

Full 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).

Enrollment: 106 patients

Sex: All

Ages: 18 to 72 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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106 participants in 2 patient groups, including a placebo group

Glutamine supplementation

Active Comparator group

Description:

Glutamine

Treatment:

Drug: Glutamine

Placebo

Placebo Comparator group

Description:

Whey protein powder

Treatment:

Drug: Glutamine