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

• ClinicalTrials.gov Identifier: NCT01414244
• Recruitment Status: Completed
• First Posted: August 11, 2011
• Results First Posted: August 9, 2017
• Last Update Posted: August 9, 2017
• Sponsor: Tulane University
• Information provided by (Responsible Party): Nicholas Verne, Tulane University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diarrhea-Predominant Irritable Bowel Syndrome	Drug: Glutamine	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 106 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Randomized, Placebo-Controlled Trial of Glutamine for the Treatment of Patients With Irritable Bowel Syndrome
• Study Start Date: November 2010
• Actual Primary Completion Date: December 30, 2015
• Actual Study Completion Date: December 30, 2015

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Glutamine supplementation; Glutamine	Drug: Glutamine; Drug; Other Name: L-Glutamine
Placebo Comparator: Placebo; Whey protein powder	Drug: Glutamine; Drug; Other Name: L-Glutamine

Outcome Measures

Primary Outcome Measures :

1. Change in the Irritable Bowel Symptom Severity Scale [ Time Frame: baseline and 8 weeks following therapy ]
   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.

Secondary Outcome Measures :

1. Intestinal Permeability [ Time Frame: baseline and 8 weeks following therapy ]
   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.
2. Stool Frequency [ Time Frame: Baseline and 8 weeks following therapy ]
   Baseline and 8 week at the conclusion of therapy
3. Stool Consistency [ Time Frame: Baseline and 8 weeks following therapy ]
   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.

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Louisiana

Tulane University School of Medicine

New Orleans, Louisiana, United States, 70112

Sponsors and Collaborators

Tulane University

Investigators

• Principal Investigator: QiQi Zhou; Tulane University School of Medicine

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Nicholas Verne, Principal Investigator, Tulane University
• ClinicalTrials.gov Identifier: NCT01414244
• Other Study ID Numbers: 11-271
• First Posted: August 11, 2011
• Results First Posted: August 9, 2017
• Last Update Posted: August 9, 2017
• Last Verified: August 2017

Individual Participant Data (IPD) Sharing Statement:

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

Keywords provided by Nicholas Verne, Tulane University:

Irritable Bowel Syndrome; Glutamine; Intestinal Permeability

Additional relevant MeSH terms:

Irritable Bowel Syndrome; Syndrome; Diarrhea; Disease; Pathologic Processes; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive