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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
Results First Received: April 10, 2017  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Glutamine Oral Glutamine Powder
Placebo Oral Whey Protein Powder

Participant Flow:   Overall Study
    Glutamine   Placebo
STARTED   54   52 
COMPLETED   54   52 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Glutamine Oral Glutamine Powder
Placebo Oral Whey Protein Powder
Total Total of all reporting groups

Baseline Measures
   Glutamine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 54   52   106 
Age 
[Units: Years]
Mean (Standard Deviation)
 32.4  (9.5)   30.9  (7.1)   31.7  (8.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      37  68.5%      37  71.2%      74  69.8% 
Male      17  31.5%      15  28.8%      32  30.2% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   54   52   106 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in the Irritable Bowel Symptom Severity Scale   [ Time Frame: baseline and 8 weeks following therapy ]

2.  Secondary:   Intestinal Permeability   [ Time Frame: baseline and 8 weeks following therapy ]

3.  Secondary:   Stool Frequency   [ Time Frame: Baseline and 8 weeks following therapy ]

4.  Secondary:   Stool Consistency   [ Time Frame: Baseline and 8 weeks following therapy ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: QiQi Zhou
Organization: Tulane University
phone: 988-7800
e-mail: qiqi06@gmail.com



Responsible Party: Nicholas Verne, Tulane University
ClinicalTrials.gov Identifier: NCT01414244     History of Changes
Other Study ID Numbers: 11-271
Study First Received: July 29, 2011
Results First Received: April 10, 2017
Last Updated: August 7, 2017