Gulf War Digestive Health Study
This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00680836
First received: May 16, 2008
Last updated: January 4, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Irritable Bowel Syndrome |
Drug: Placebo Drug: Rifaximin |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by Department of Veterans Affairs:
Primary Outcome Measures:
- Improvement in IBS Global Improvement Scale. [ Time Frame: once a month for the 6 months following completion of medication ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 140 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | December 2013 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: Rifaximin
550 mg orally two times per day for 14 days
|
|
Placebo Comparator: Arm 3
These patients have IBS and are receiving the placebo.
|
Drug: Placebo
orally two times per day for 14 days
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 35 Years to 72 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Men and women age 32-75 years
- Rome III criteria for diarrhea-predominant IBS
- Symptom onset after an apparent episode of acute gastroenteritis
- Symptoms of > 3 months duration
- Normal endoscopic appearance of the colonic mucosa
- Negative markers for celiac disease and inflammatory bowel disease.
- Normal thyroid function and serum calcium levels.
- Must have served in the military or reserves during the time of Operation Desert Storm (August 1990 to May 1991)
Exclusion Criteria:
- Clinically significant cardiac, pulmonary, hepatic or renal dysfunction
- History of/or presence of systemic malignancy
- Current evidence of any gastrointestinal disorder such as celiac disease or inflammatory bowel disease (i.e. Crohns disease or ulcerative colitis)
- Current effects of drug or alcohol abuse
- Investigator perception of patients inability to comply with study protocol
- Unstable psychiatric disease
- Recent change in gastrointestinal medications
- Subjects with a positive pregnancy test
- Subject is currently participating in another research protocol that could interfere or influence the outcome measures of the present study
Contacts and Locations More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00680836 History of Changes |
| Other Study ID Numbers: | GWRA-014-05F |
| Study First Received: | May 16, 2008 |
| Last Updated: | January 4, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Irritable Bowel Syndrome Diarrhea |
Additional relevant MeSH terms:
|
Irritable Bowel Syndrome Colonic Diseases, Functional Colonic Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
Rifaximin Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 23, 2013