N/A
N=54
Gulf War Digestive Health Study
Irritable Bowel Syndrome · Small Intestinal Bacterial Overgrowth
Bottom Line
View on ClinicalTrials.gov: NCT00680836 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Global Improvement Scale — 4.3; 4.3 units on a scale — p=0.26
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Placebo (Drug); Rifaximin (Drug)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Global Improvement Scale |
4.3; 4.3 | 0.26 |
| SECONDARY Change in Stool Frequency (Number of Bowel Movements Per Day) |
-0.3; -0.1 | 0.98 |
| SECONDARY Change in Stool Consistency |
-0.4; -0.3 | 0.78 |
| SECONDARY Change in Bowel Urgency |
0.0; -0.1 | 0.64 |
| SECONDARY Change in Abdominal Pain With Bowel Movement |
-0.3; -0.2 | 0.72 |
| SECONDARY Change in Bloating |
-0.2; -0.2 | 0.86 |
Summary
The purposes of this study are to estimate the burden of disease due to chronic gastrointestinal illness in PG veterans, to evaluate whether Small Bowel Bacterial Overgrowth (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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00680836). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.