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Glutamine for the Treatment of Patients With Irritable Bowel Syndrome (AT005291)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01414244
Recruitment Status : Completed
First Posted : August 11, 2011
Results First Posted : August 9, 2017
Last Update Posted : August 9, 2017
Sponsor:
Information provided by (Responsible Party):
Nicholas Verne, Tulane University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Diarrhea-Predominant Irritable Bowel Syndrome
Intervention Drug: Glutamine
Enrollment 106
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Glutamine Placebo
Hide Arm/Group Description Oral Glutamine Powder Oral Whey Protein Powder
Period Title: Overall Study
Started 54 52
Completed 54 52
Not Completed 0 0
Arm/Group Title Glutamine Placebo Total
Hide Arm/Group Description Oral Glutamine Powder Oral Whey Protein Powder Total of all reporting groups
Overall Number of Baseline Participants 54 52 106
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants 52 participants 106 participants
32.4  (9.5) 30.9  (7.1) 31.7  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 52 participants 106 participants
Female
37
  68.5%
37
  71.2%
74
  69.8%
Male
17
  31.5%
15
  28.8%
32
  30.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 54 participants 52 participants 106 participants
54 52 106
1.Primary Outcome
Title Change in the Irritable Bowel Symptom Severity Scale
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glutamine Placebo
Hide Arm/Group Description:
Oral Glutamine Powder
Oral Whey Protein Powder
Overall Number of Participants Analyzed 54 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
181  (48) 301  (57)
2.Secondary Outcome
Title Intestinal Permeability
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glutamine Placebo
Hide Arm/Group Description:
Oral Glutamine Powder
Oral Whey Protein Powder
Overall Number of Participants Analyzed 54 52
Mean (Standard Deviation)
Unit of Measure: lactulose/mannitol (L/M)
0.05  (0.01) 0.10  (0.03)
3.Secondary Outcome
Title Stool Frequency
Hide Description Baseline and 8 week at the conclusion of therapy
Time Frame Baseline and 8 weeks following therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glutamine Placebo
Hide Arm/Group Description:
Oral Glutamine Powder
Oral Whey Protein Powder
Overall Number of Participants Analyzed 54 52
Mean (Standard Deviation)
Unit of Measure: stools per day
2.9  (0.9) 5.3  (2.1)
4.Secondary Outcome
Title Stool Consistency
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glutamine Placebo
Hide Arm/Group Description:
Oral Glutamine Powder
Oral Whey Protein Powder
Overall Number of Participants Analyzed 54 52
Mean (Standard Deviation)
Unit of Measure: units on a scale (1-7)
3.9  (1.2) 6.6  (0.53)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Glutamine Placebo
Hide Arm/Group Description Oral Glutamine Powder Oral Whey Protein Powder
All-Cause Mortality
Glutamine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/54 (0.00%)   0/52 (0.00%) 
Hide Serious Adverse Events
Glutamine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/54 (0.00%)   0/52 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Glutamine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/54 (0.00%)   0/52 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: QiQi Zhou
Organization: Tulane University
Phone: 988-7800
EMail: qiqi06@gmail.com
Layout table for additonal information
Responsible Party: Nicholas Verne, Tulane University
ClinicalTrials.gov Identifier: NCT01414244    
Other Study ID Numbers: 11-271
First Submitted: July 29, 2011
First Posted: August 11, 2011
Results First Submitted: April 10, 2017
Results First Posted: August 9, 2017
Last Update Posted: August 9, 2017