Bacterial Overgrowth Associated With Chronic Multisymptom Illness Complex - Full Text View

Sponsor:	Department of Defense
Information provided by:	New Mexico VA Healthcare System
ClinicalTrials.gov Identifier:	NCT00956150

Purpose

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.

Condition	Intervention
Gulf War Syndrome	Procedure: Lactulose Breath Test Drug: Rifaximin Drug: Placebo Drug: Erythromycin ethylsuccinate (EES) Drug: Bismuth subsalicylate

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Bacterial Overgrowth Associated With Chronic Multisymptom Illness Complex

Resource links provided by NLM:

Drug Information available for: Dioctyl sulfosuccinic acid Bismuth subsalicylate Erythromycin Gluceptate Rifaximin Erythromycin Docusate calcium Erythromycin stearate Erythromycin ethylsuccinate Erythromycin estolate Lactulose Bismuth Kaopectate

U.S. FDA Resources

Further study details as provided by New Mexico VA Healthcare System:

Primary Outcome Measures:

To compare the pattern of bacterial gas excretion in breath among Veterans with Gulf War Syndrome vs. Controls using Lactulose Breath Test [ Time Frame: every 15 minutes for 180 minutes ] [ Designated as safety issue: No ]
To determine the response to antibiotic treatment in Gulf War Syndrome patients. [ Time Frame: Two weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	210
Study Start Date:	April 2009
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: GWS and Controls	Procedure: Lactulose Breath Test
Active Comparator: 60 GWS Rifaximin	Drug: Rifaximin Rifaximin 600 mg TID PO x 10 days
Placebo Comparator: 20 GWS Placebo	Drug: Placebo Placebo at bedtime PO
Active Comparator: 40 GWS Bismuth	Drug: Bismuth subsalicylate Bismuth subsalicylate 524 mg tablets QID x 7 days
Placebo Comparator: 60 GWS Placebo	Drug: Placebo Placebo TID PO x 10 days
Active Comparator: 20 GWS Eythromycin	Drug: Erythromycin ethylsuccinate (EES) Erythromycin 50 mg PO at bedtime

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00956150

Contacts

Contact: Lisa R Fowles, BS	505-265-1711 ext 2286	LFowles@salud.unm.edu
Contact: Henry C Lin, MD	505-265-1711 ext 4511	helin@salud.unm.edu

Locations

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

Sponsors and Collaborators

Department of Defense

More Information

No publications provided

Responsible Party:	Henry C. Lin, MD, VA Healthcare System
ClinicalTrials.gov Identifier:	NCT00956150 History of Changes
Other Study ID Numbers:	HRRC 07-155
Study First Received:	August 10, 2009
Last Updated:	February 25, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by New Mexico VA Healthcare System:

Chronic Multisymptom Complex
Small Intestinal Bacterial Overgrowth
Gulf War Syndrome
Chronic Multisymptom Illness Complex

Additional relevant MeSH terms:

Persian Gulf Syndrome
Occupational Diseases
Bismuth
Bismuth subsalicylate
Erythromycin stearate
Rifaximin
Erythromycin Ethylsuccinate
Erythromycin
Erythromycin Estolate
Lactulose

Antacids
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antidiarrheals
Gastrointestinal Agents
Therapeutic Uses
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Protein Synthesis Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012