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Completed

NCT Number: NCT01414244

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.

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Key information

Conditions

Diarrhea-predominant Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome

Age range

18 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

glutamine

Drug

Drug

Other names: L-Glutamine

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Tulane University

Other

Registry information

Official study title

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

Acronym: AT005291

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Aug 11, 2011
Registry last updated
Aug 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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