Bacterial Overgrowth Associated With Chronic Multisymptom Illness Complex

Condition(s) targeted: Gulf War Syndrome

Intervention: Lactulose Breath Test (Procedure); Rifaximin (Drug); Placebo (Drug); Erythromycin ethylsuccinate (EES) (Drug); Placebo (Drug); Bismuth subsalicylate (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: VA Merit Review, DOD (Department of Defense)

Overall contact:
Lisa R Fowles, BS, Phone: 505-265-1711, Ext: 2286, Email: LFowles@salud.unm.edu

The adverse impact of 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 160 patients with GWS and 90 healthy controls. The investigators 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.

Official title: Bacterial Overgrowth Associated With Chronic Multisymptom Illness Complex

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Primary outcome:

To compare the pattern of bacterial gas excretion in breath among Veterans with Gulf War Syndrome vs. Controls using Lactulose Breath Test

To determine the response to antibiotic treatment in Gulf War Syndrome patients.

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Gulf War Veterans meeting the 1994 CDC criteria for the diagnosis of 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 IBS, FM, anxiety or depression will not be excluded, but will be

identified for subgroup analysis

- Healthy controls will be screened with 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

Lisa R Fowles, BS, Phone: 505-265-1711, Ext: 2286, Email: LFowles@salud.unm.edu

New Mexico VA Healthcare System, Albuquerque, New Mexico 87108, United States; Recruiting
Lisa R Fowles, BS, Phone: 505-265-1711, Ext: 2286, Email: LFowles@salud.unm.edu
Henry C Lin, MD, Phone: 505-265-1711, Ext: 4511, Email: helin@salud.unm.edu
Henry C Lin, MD, Principal Investigator

Starting date: April 2009
Last updated: August 10, 2009