Bacterial Overgrowth Associated With Chronic Multisymptom Illness Complex

Status unconfirmed · Phase 1 · Has a placebo group

Conditions studied: Gulf War Syndrome

In brief

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.

Key facts

Study ID

NCT00956150

Run by

Henry C. Lin, MD

People needed

210

Starts

2009-04-01

Last updated by the study team

2013-05-01

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Gulf War Veterans meeting the 1994 Centers for Disease Control and Prevention (CDC) criteria for the diagnosis of Chronic Fatigue Syndrome(CFS), i.e > six months of one or more symptoms from at least two of the following three clusters: general fatigue, mood and cognitive abnormalities, and musculoskeletal pain
• 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

You may not qualify if…

• History of peptic ulcer, inflammatory bowel disease, diabetes, cirrhosis, rheumatoid arthritis, lupus, narcotic dependence,celiac disease, tropical sprue, bowel resection(including gastric, small bowel or colon; but gallbladder surgery or appendectomy are NOT exclusion criteria)
• Patients with chronic illness (HIV, tuberculosis)
• Pregnant or breast-feeding, psychotic depression, bipolar disorder, schizophrenia, eating disorders
• Healthy subjects will be excluded if their questionnaire indicated abnormal symptom profile

Where it is running

• New Mexico VA Healthcare System — Albuquerque, New Mexico, United States (enrolling)

Full record on ClinicalTrials.gov

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