Glutamine for the Treatment of Patients With Irritable Bowel Syndrome (AT005291)
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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.
Condition or disease
Diarrhea-Predominant Irritable Bowel Syndrome
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).
Change in the Irritable Bowel Symptom Severity Scale [ Time Frame: 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
Intestinal Permeability [ Time Frame: 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 [ Time Frame: Baseline and 8 weeks following therapy ]
Baseline and 8 week at the conclusion of therapy
Stool Consistency [ Time Frame: 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.
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Ages Eligible for Study:
18 Years to 72 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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