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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nicholas Verne, Tulane University
ClinicalTrials.gov Identifier:
NCT01414244
First received: July 29, 2011
Last updated: August 7, 2017
Last verified: August 2017
  Purpose
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 Intervention Phase
Diarrhea-Predominant Irritable Bowel Syndrome Drug: Glutamine Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Nicholas Verne, Tulane University:

Primary Outcome Measures:
  • 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:
  • 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.

  • Stool Frequency [ Time Frame: Baseline and 8 weeks following therapy ]
    Baseline and 8 week at the conclusion of therapy

  • 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.


Enrollment: 106
Study Start Date: November 2010
Study Completion Date: December 30, 2015
Primary Completion Date: December 30, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 72 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01414244

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

Responsible Party: Nicholas Verne, Principal Investigator, Tulane University
ClinicalTrials.gov Identifier: NCT01414244     History of Changes
Other Study ID Numbers: 11-271
Study First Received: July 29, 2011
Results First Received: April 10, 2017
Last Updated: August 7, 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:
Syndrome
Diarrhea
Irritable Bowel Syndrome
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 19, 2017