Glutamine for the Treatment of Patients With Irritable Bowel Syndrome
Completed · Phase 2 · Has a placebo group
Conditions studied: Diarrhea-Predominant Irritable Bowel Syndrome
In brief
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.
Key facts
- Study ID
- NCT01414244
- Run by
- Tulane University
- People needed
- 106
- Starts
- 2010-11-01
- Expected to finish
- 2015-12-30
- Last updated by the study team
- 2017-08-09
Who can join
Age: 18 and older, up to 72. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Tulane University School of Medicine — New Orleans, Louisiana, United States
Full record on ClinicalTrials.gov
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