Gulf War Digestive Health Study
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|ClinicalTrials.gov Identifier: NCT00680836|
Recruitment Status : Completed
First Posted : May 20, 2008
Results First Posted : August 29, 2014
Last Update Posted : August 29, 2014
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome Small Intestinal Bacterial Overgrowth||Drug: Placebo Drug: Rifaximin||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Diarrhea-Predominant Irritable Bowel Syndrome in Persian Gulf Veterans|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||December 2013|
Active Comparator: Treatment Group
These patients have IBS and are receiving the rifaximin.
550 mg orally two times per day for 14 days
Other Name: Xifaxan
Placebo Comparator: Placebo group
These patients have IBS and are receiving the placebo.
orally two times per day for 14 days
Other Name: Inactive pill
- Global Improvement Scale [ Time Frame: Measured for seven days at the end of 2 weeks treatment and average score is calculated ]Improvement in Irritable Bowel Syndrome symptoms post treatment is measured. This scale is not measured at baseline. Participants are asked if their symptoms improved or got worse and to rate it on a scale of 1- 7 for seven days. Average score for 7 days is calculated. The Global improvement scale ranges from 1- 7. Score of 1-3 means the IBS symptoms got worse, 4 means no change and 5-7 means improvement in the IBS symptoms.
- Change in Stool Frequency (Number of Bowel Movements Per Day) [ Time Frame: 2 weeks ]Change in stool frequency (number of bowel movements per day) compared from baseline to post treatment is measured. Number of bowel movements per day before treatment is subtracted from the number of bowel movements per day after treatment. The change in frequency has been reported in the outcomes table.
- Change in Stool Consistency [ Time Frame: 2 weeks ]Change in Stool consistency from baseline to post treatment is measured. Bristol stool scale is used for this purpose. The scale ranges from a value of 1- 7; 1 being very hard stool to 7 being liquid stools. The change is measured for 1 week post-treatment and the average consistency is used for the purpose of measuring change from baseline.
- Change in Bowel Urgency [ Time Frame: 2 weeks ]Urgency in a bowel movements compared from baseline to post treatment was measured. Participants were asked to note if they had urgency at bowel movements (meaning if they had to rush to the restroom). They marked either 'yes' or 'no'. The percentage of the time they said yes was calculated for 7 days. The difference between baseline and post treatment urgency was calculated.
- Change in Abdominal Pain With Bowel Movement [ Time Frame: 2 weeks ]Severity of abdominal pain on a scale of 0 to 4 was measured; 0 meaning no pain to 4 meaning severe pain. Change in abdominal pain from baseline to post treatment was calculated.
- Change in Bloating [ Time Frame: 2 weeks ]Bloating is measured on a scale from 0 to 4; 0 = no bloating to 4 = severe bloating. Change in bloating is calculated from baseline to post treatment.
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): NCT00680836
|United States, Utah|
|Division of Epidemiology|
|Salt Lake City, Utah, United States, 84132|
|Principal Investigator:||Ashok K Tuteja, MD MPH||Division of Epidemiology|