Glutamine for the Treatment of Patients With Irritable Bowel Syndrome

Diarrhea-Predominant Irritable Bowel Syndrome Clinical Trial

— AT005291  

Official title:

Randomized, Placebo-Controlled Trial of Glutamine for the Treatment of Patients With Irritable Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01414244
• Other study ID #: 11-271
• Status: Completed
• Phase: Phase 2
• First received: July 29, 2011
• Last updated: August 7, 2017
• Start date: November 2010
• Est. completion date: December 30, 2015

Study information

• Verified date: August 2017
• Source: Tulane University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: December 30, 2015
• Est. primary completion date: December 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 72 Years

Eligibility

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

Related Conditions & MeSH terms

• Diarrhea
• Diarrhea-Predominant Irritable Bowel Syndrome
• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Glutamine
Drug

Locations

Country	Name	City	State
United States	Tulane University School of Medicine	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Tulane University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Irritable Bowel Symptom Severity Scale	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.	baseline and 8 weeks following therapy
Secondary	Intestinal Permeability	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.	baseline and 8 weeks following therapy
Secondary	Stool Frequency	Baseline and 8 week at the conclusion of therapy	Baseline and 8 weeks following therapy
Secondary	Stool Consistency	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.	Baseline and 8 weeks following therapy