Glutamine for the Treatment of Patients With Irritable Bowel Syndrome (AT005291)
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|ClinicalTrials.gov Identifier: NCT01414244|
Recruitment Status : Completed
First Posted : August 11, 2011
Results First Posted : August 9, 2017
Last Update Posted : August 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diarrhea-Predominant Irritable Bowel Syndrome||Drug: Glutamine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Randomized, Placebo-Controlled Trial of Glutamine for the Treatment of Patients With Irritable Bowel Syndrome|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||December 30, 2015|
|Actual Study Completion Date :||December 30, 2015|
Active Comparator: Glutamine supplementation
Other Name: L-Glutamine
Placebo Comparator: Placebo
Whey protein powder
Other Name: L-Glutamine
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01414244
|United States, Louisiana|
|Tulane University School of Medicine|
|New Orleans, Louisiana, United States, 70112|
|Principal Investigator:||QiQi Zhou||Tulane University School of Medicine|