Glutamine for the Treatment of Patients With Irritable Bowel Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 17 December 2012
• Main ID: NCT01414244
• Date of registration: 29/07/2011
• Primary sponsor: The University of Texas, Galveston
• Public title: Glutamine for the Treatment of Patients With Irritable Bowel Syndrome
• Scientific title: Randomized, Placebo-Controlled Trial of Glutamine for the Treatment of Patients With Irritable Bowel Syndrome
• Date of first enrolment: November 2010
• Target sample size: 100
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01414244
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: QiQi Zhou, M.D., Ph.D.

• Name: QiQi Zhou, M.D., Ph.D

• Name: QiQi Zhou
• Affiliation: University of Texas, Galveston

Key inclusion & exclusion criteria

Inclusion Criteria:

- men and women age 18-72 years old that meet the Rome III criteria for
diarrhea-predominant IBS (D-IBS) for at least 1 year prior to study

- increased intestinal membrane permeability on Lactulose/Mannitol permeability test

- score between 37 and 110 on the Functional Bowel Disorder Severity Index (FBDSI)

- able and willing to cooperate with the study

- *absence of alcohol 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 >6 months
prior to entry into the study

- Beck Depression Inventory score of =30, State Trait Anxiety Inventory =53.

- Abnormal blood urea nitrogen(BUN) and/or creatinine



Age minimum: 18 Years
Age maximum: 72 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Irritable Bowel Syndrome

Intervention(s)

Dietary Supplement: Glutamine Supplementation

Dietary Supplement: Placebo

Drug: Glutamine

Primary Outcome(s)

Change in the Irritable Bowel Symptom Severity Scale [Time Frame: baseline and at 2, 4, 6, and 8 weeks following therapy]

Secondary Outcome(s)

Change in Intestinal Permeability [Time Frame: baseline and 2, 4, 6, and 8 weeks following therapy]

Secondary ID(s)

AT005291

Source(s) of Monetary Support

Please refer to primary and secondary sponsors