Bacterial Overgrowth Associated With Chronic Multisymptom Illness Complex
NCT ID: NCT00956150
Last Updated: 2013-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
210 participants
INTERVENTIONAL
2009-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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60 GWS Rifaximin
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).
Rifaximin
Rifaximin 600 mg three times a day by mouth (TID PO) x 10 days
60 GWS Placebo
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).
Placebo
Placebo TID PO x 10 days
Healthy Control
Patient is a healthy control and will not be on study intervention. Asked to perform Lactulose Breath Test to compare results with GWS patients.
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).
Interventions
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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).
Rifaximin
Rifaximin 600 mg three times a day by mouth (TID PO) x 10 days
Placebo
Placebo TID PO x 10 days
Eligibility Criteria
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Inclusion Criteria
* Must be under the care of a primary physician and have had a previous diagnosis of Gulf War-related illness or GWS and have medical records documenting investigations to rule out other causes of fatigue
* Minimum of the following laboratory screening tests: complete blood count with leukocyte differential, erythrocyte sedimentation rate, serum electrolytes, calcium, glucose, blood urea nitrogen, creatinine,urinalysis, and thyroid function tests
* Subjects must also have a GI consult first as part of routine care to confirm eligibility and availability
* Patients with Irritable Bowel Syndrome (IBS), fibromyalgia (FM), anxiety or depression will not be excluded, but will be identified for subgroup analysis
* Healthy controls will be screened with complete blood count (CBC) and comprehensive metabolic panel to confirm eligibility
Exclusion Criteria
* Pregnant or breast-feeding, psychotic depression, bipolar disorder, schizophrenia, eating disorders
* Healthy subjects will be excluded if their questionnaire indicated abnormal symptom profile
21 Years
ALL
Yes
Sponsors
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Henry C. Lin, MD
FED
Responsible Party
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Henry C. Lin, MD
Henry C. Lin, MD
Locations
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New Mexico VA Healthcare System
Albuquerque, New Mexico, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HRRC 07-155
Identifier Type: -
Identifier Source: org_study_id
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