Gulf War Digestive Health Study
The purposes of this study are to estimate the burden of disease due to chronic gastrointestinal illness in PG veterans, to evaluate whether SBBO is associated with chronic diarrhea in PG veterans, and to determine whether eradication of SBBO reduces symptoms of chronic diarrhea, abdominal pain and bloating in PG veterans.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Diarrhea-Predominant Irritable Bowel Syndrome in Persian Gulf Veterans|
- Improvement in IBS Global Improvement Scale. [ Time Frame: once a month for the 6 months following completion of medication ] [ Designated as safety issue: No ]
- Change in Symptom Severity [ Time Frame: 6 months after medication regimen is completed ] [ Designated as safety issue: No ]
- Change in IBS-QOL Questionnaire [ Time Frame: 1 week after starting the medication, 2 weeks after starting the medication, 1 month after finishing medication, 6 months after finishing medication ] [ Designated as safety issue: No ]
- Change in LBT [ Time Frame: 6 months after completion of medication ] [ Designated as safety issue: No ]
|Study Start Date:||October 2007|
|Estimated Study Completion Date:||December 2013|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
No Intervention: Arm 1
These patients do not have IBS. They may be deployed or non-deployed veterans.
Active Comparator: Arm 2
These patients have IBS and are receiving the rifaximin.
550 mg orally two times per day for 14 days
Placebo Comparator: Arm 3
These patients have IBS and are receiving the placebo.
orally two times per day for 14 days
Show Detailed Description
|United States, Utah|
|Division of Epidemiology|
|Salt Lake City, Utah, United States, 84132|
|Principal Investigator:||Ashok K Tuteja, MD MPH||Division of Epidemiology|