Bacterial Overgrowth Associated With Chronic Multisymptom Illness Complex
NCT00956150 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 210
Last updated 2013-05-01
Summary
The adverse impact of Gulf War Syndrome (GWS) on the health of veterans and on the resources of the VA Healthcare System underscores the need to resolve its underlying cause. In response, the investigators propose to investigate the central hypothesis that gut bacteria may be responsible for symptoms associated with GWS. The investigators will enroll a total of 120 patients with GWS and 90 healthy controls.
Conditions
- Gulf War Syndrome
Interventions
- PROCEDURE
-
Lactulose Breath Test
Test will begin with a baseline breath sample followed by ingestion of 10g of lactulose (Xactdose, South Beloit, IL) in 100ml of water. Breath samples will be collected every 15 min for 180 min. Gas samples will be analyzed for hydrogen and methane using a gas chromatograph (Model SC, Quintron Instruments, Milwaukee, WI).
- DRUG
-
Rifaximin
Rifaximin 600 mg three times a day by mouth (TID PO) x 10 days
- DRUG
-
Placebo TID PO x 10 days
Sponsors & Collaborators
-
Henry C. Lin, MD
lead FED
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2009-04-30
- Primary Completion
- 2014-03-31
Countries
- United States
Study Locations
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