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

Purpose

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.

Condition	Intervention	Phase
Gulf War Syndrome	Procedure: Lactulose Breath Test Drug: Rifaximin Drug: Placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment 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: Lactulose Rifaximin

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 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 60 GWS Rifaximin	Procedure: 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). Drug: Rifaximin Rifaximin 600 mg three times a day by mouth (TID PO) x 10 days
Placebo Comparator: 60 GWS Placebo	Procedure: 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). Drug: Placebo Placebo TID PO x 10 days
Experimental: 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.	Procedure: 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).

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

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 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

Contacts and Locations

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

Contacts

Contact: Natalie R Mills, BS	505-265-1711 ext 2286	Natalie.Mills@va.gov
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: Natalie R Mills, BS 505-265-1711 ext 2286 Natalie.Mills@va.gov
Contact: Henry C Lin, MD 505-265-1711 ext 4511 helin@salud.unm.edu
Principal Investigator: Henry C Lin, MD

Sponsors and Collaborators

Henry C. Lin, MD

More Information

No publications provided

Responsible Party:	Henry C. Lin, MD, New Mexico 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:	April 30, 2013
Health Authority:	United States: Food and Drug Administration United Stated: Department of Defense (DoD) United States: Central Data Monitoring Committee (CDMC) United States: VA Merit Review United States: Human Research Review Committee United States: VA Research and Development Committee

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
Rifaximin
Lactulose

Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents

ClinicalTrials.gov processed this record on June 17, 2013