Glutamine for the Treatment of Patients With Irritable Bowel Syndrome

Tulane University106 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

106

Conditions

Diarrhea-Predominant Irritable Bowel Syndrome

Interventions

GlutamineDRUG

Drug

Eligibility

Sex: ALLMin age: 18 YearsMax age: 72 Years

Medical Language ↔ Plain English

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

Locations (1)

Tulane University School of Medicine

New Orleans, Louisiana, United States

Outcomes

Primary Outcomes

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.

Time frame: baseline and 8 weeks following therapy

Secondary Outcomes

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.

Time frame: baseline and 8 weeks following therapy

Stool Frequency

Baseline and 8 week at the conclusion of therapy

Time frame: 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.

Time frame: Baseline and 8 weeks following therapy

Data from ClinicalTrials.gov

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