Phase 2 N=106 Randomized Triple-blind Treatment

Glutamine for the Treatment of Patients With Irritable Bowel Syndrome

Diarrhea-Predominant Irritable Bowel Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT01414244 ↗

Enrolled (actual)

106

Serious AEs

0.0%

Results posted

Aug 2017

Primary outcome: Primary: Change in the Irritable Bowel Symptom Severity Scale — 181; 301 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Glutamine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Tulane University
Primary completion: Dec 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in the Irritable Bowel Symptom Severity Scale	181; 301	—
SECONDARY Intestinal Permeability	0.05; 0.10	—
SECONDARY Stool Frequency	2.9; 5.3	—
SECONDARY Stool Consistency	3.9; 6.6	—

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 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.

Eligibility Criteria

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

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Data sourced from ClinicalTrials.gov (NCT01414244). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.