Bacterial Overgrowth Associated With Chronic Multisymptom Illness Complex
Information source: New Mexico VA Healthcare System
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gulf War Syndrome
Intervention: Lactulose Breath Test (Procedure); Rifaximin (Drug); Placebo (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Henry C. Lin, MD Overall contact: Natalie R Mills, BS, Phone: 505-265-1711, Ext: 2286, Email: Natalie.Mills@va.gov
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.
Clinical Details
Official title: Bacterial Overgrowth Associated With Chronic Multisymptom Illness Complex
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: To compare the pattern of bacterial gas excretion in breath among Veterans with Gulf War Syndrome vs. Controls using Lactulose Breath TestTo determine the response to antibiotic treatment in Gulf War Syndrome patients.
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.
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Locations and Contacts
Natalie R Mills, BS, Phone: 505-265-1711, Ext: 2286, Email: Natalie.Mills@va.gov
New Mexico VA Healthcare System, Albuquerque, New Mexico 87108, United States; Recruiting Natalie R Mills, BS, Phone: 505-265-1711, Ext: 2286, Email: Natalie.Mills@va.gov Henry C Lin, MD, Phone: 505-265-1711, Ext: 4511, Email: helin@salud.unm.edu Henry C Lin, MD, Principal Investigator
Additional Information
Starting date: April 2009
Last updated: April 30, 2013
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