NCT00956150

Bacterial Overgrowth Associated With Chronic Multisymptom Illness Complex

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Henry C. Lin, MD · Federal
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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.

Detailed description

The investigator will assess the prevalence and role of abnormal gut microbial fermentation among Veterans with GWS and investigate the efficacy of diagnostic and treatment strategies directed at indigenous gut microbes in the management of GWS.

Conditions

• Gulf War Syndrome

Interventions

Type	Name	Description
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	Placebo TID PO x 10 days

Timeline

• Start date: 2009-04-01
• Primary completion: 2014-03-01
• First posted: 2009-08-11
• Last updated: 2013-05-01

Locations

1 site across 1 country: United States