Glutamine for the Treatment of Patients With Irritable Bowel Syndrome (AT005291)

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

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.

Study Overview

• Status: Completed
• Conditions: Diarrhea-Predominant Irritable Bowel Syndrome
• Intervention / Treatment: Drug: Glutamine

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).

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 72 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Glutamine supplementation; Glutamine	Drug: Glutamine; Drug; Other Names: L-Glutamine
Placebo Comparator: Placebo; Whey protein powder	Drug: Glutamine; Drug; Other Names: L-Glutamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Stool Frequency	Baseline and 8 week at the conclusion of therapy	Baseline and 8 weeks following therapy
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

Collaborators and Investigators

• Sponsor: Tulane University
• Investigators: Principal Investigator: QiQi Zhou, Tulane University School of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): December 30, 2015
• Study Completion (Actual): December 30, 2015

Study Registration Dates

• First Submitted: July 29, 2011
• First Submitted That Met QC Criteria: August 10, 2011
• First Posted (Estimate): August 11, 2011

Study Record Updates

• Last Update Posted (Actual): August 9, 2017
• Last Update Submitted That Met QC Criteria: August 7, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Irritable Bowel Syndrome; Glutamine; Intestinal Permeability
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Diarrhea
• Other Study ID Numbers: 11-271

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Some data will be available through publications, however further plans to make all IPD available is unknown.