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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
July 29, 2011
August 7, 2017
November 2010
December 30, 2015   (Final data collection date for primary outcome measure)
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.
Change in the Irritable Bowel Symptom Severity Scale [ Time Frame: baseline and at 2, 4, 6, and 8 weeks following therapy ]
The primary outcome measure will be a change in the Irritable Bowel Symptom Severity Scale from baseline to 2, 4, 6, and 8 weeks following therapy.
Complete list of historical versions of study NCT01414244 on ClinicalTrials.gov Archive Site
  • 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.
Change in Intestinal Permeability [ Time Frame: baseline and 2, 4, 6, and 8 weeks following therapy ]
The secondary outcome measure will be a change in intestinal permeability from base to 2, 4, 6, and 8 weeks following therapy.
Not Provided
Not Provided
 
Glutamine for the Treatment of Patients With Irritable Bowel Syndrome
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.
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).
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Diarrhea-Predominant Irritable Bowel Syndrome
Drug: Glutamine
Drug
Other Name: L-Glutamine
  • Active Comparator: Glutamine supplementation
    Glutamine
    Intervention: Drug: Glutamine
  • Placebo Comparator: Placebo
    Whey protein powder
    Intervention: Drug: Glutamine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
December 30, 2015
December 30, 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 72 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01414244
11-271
Yes
Not Provided
Plan to Share IPD: Undecided
Plan Description: Some data will be available through publications, however further plans to make all IPD available is unknown.
Nicholas Verne, Tulane University
Tulane University
Not Provided
Principal Investigator: QiQi Zhou Tulane University School of Medicine
Tulane University
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP