Status:
COMPLETED
Glutamine for the Treatment of Patients With Irritable Bowel Syndrome
Lead Sponsor:
Tulane University
Conditions:
Diarrhea-Predominant Irritable Bowel Syndrome
Eligibility:
All Genders
18-72 years
Phase:
PHASE2
Brief 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 gl...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2015
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT01414244
Start Date
November 1 2010
End Date
December 30 2015
Last Update
August 9 2017
Active Locations (1)
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1
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112