Clinical trial NCT01414244: Glutamine for the Treatment of Patients With Irritable Bowel Syndrome
Official title: Randomized, Placebo-Controlled Trial of Glutamine for the Treatment of Patients With Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diarrhea-Predominant Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome
Glutamine
Intestinal Permeability
Lead sponsor: Tulane University
Sponsor class: OTHER
First posted: 2011-08-11
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 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).

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

Primary outcomes:
measure: Change in the Irritable Bowel Symptom Severity Scale
timeFrame: baseline and 8 weeks following therapy
Secondary outcomes:
measure: Intestinal Permeability
timeFrame: baseline and 8 weeks following therapy
measure: Stool Frequency
timeFrame: Baseline and 8 weeks following therapy
measure: Stool Consistency
timeFrame: Baseline and 8 weeks following therapy
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Tulane University School of Medicine
state: Louisiana
Study officials:
affiliation: Tulane University School of Medicine
name: QiQi Zhou
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhou Q, Verne ML, Fields JZ, Lefante JJ, Basra S, Salameh H, Verne GN. Randomised placebo-controlled trial of dietary glutamine supplements for postinfectious irritable bowel syndrome. Gut. 2019 Jun;68(6):996-1002. doi: 10.1136/gutjnl-2017-315136. Epub 2018 Aug 14.