Back to resultsGlutamine for the Treatment of Patients With Irritable Bowel Syndrome (AT005291)
Primary Purpose
Diarrhea-Predominant Irritable Bowel Syndrome
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Glutamine
Sponsored by
About this trial
This is an interventional treatment trial for Diarrhea-Predominant Irritable Bowel Syndrome focused on measuring Irritable Bowel Syndrome, Glutamine, Intestinal Permeability
Eligibility 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
Sites / Locations
- Tulane University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Glutamine supplementation
Placebo
Arm Description
Glutamine
Whey protein powder
Outcomes
Primary Outcome Measures
Change in the Irritable Bowel Symptom Severity Scale
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
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
Baseline and 8 week at the conclusion of therapy
Stool Consistency
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01414244
Brief Title
Glutamine for the Treatment of Patients With Irritable Bowel Syndrome
Acronym
AT005291
Official Title
Randomized, Placebo-Controlled Trial of Glutamine for the Treatment of Patients With Irritable Bowel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 30, 2015 (Actual)
Study Completion Date
December 30, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tulane University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea-Predominant Irritable Bowel Syndrome
Keywords
Irritable Bowel Syndrome, Glutamine, Intestinal Permeability
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glutamine supplementation
Arm Type
Active Comparator
Arm Description
Glutamine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Whey protein powder
Intervention Type
Drug
Intervention Name(s)
Glutamine
Other Intervention Name(s)
L-Glutamine
Intervention Description
Drug
Primary Outcome Measure Information:
Title
Change in the Irritable Bowel Symptom Severity Scale
Description
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.
Time Frame
baseline and 8 weeks following therapy
Secondary Outcome Measure Information:
Title
Intestinal Permeability
Description
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.
Time Frame
baseline and 8 weeks following therapy
Title
Stool Frequency
Description
Baseline and 8 week at the conclusion of therapy
Time Frame
Baseline and 8 weeks following therapy
Title
Stool Consistency
Description
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.
Time Frame
Baseline and 8 weeks following therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
QiQi Zhou
Organizational Affiliation
Tulane University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tulane University School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Some data will be available through publications, however further plans to make all IPD available is unknown.
Citations:
PubMed Identifier
30108163
Citation
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.
Results Reference
derived
Learn more about this trial
Glutamine for the Treatment of Patients With Irritable Bowel Syndrome
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