Glutamine for the Treatment of Patients With Irritable Bowel Syndrome

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2015-12-30

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.

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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).

Conditions

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Diarrhea-Predominant Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Glutamine supplementation

Glutamine

Group Type ACTIVE_COMPARATOR

Glutamine

Intervention Type DRUG

Drug

Placebo

Whey protein powder

Group Type PLACEBO_COMPARATOR

Glutamine

Intervention Type DRUG

Drug

Interventions

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Glutamine

Drug

Intervention Type DRUG

Other Intervention Names

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L-Glutamine

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No