Bacterial Overgrowth Associated With Chronic Multisymptom Illness Complex

Gulf War Syndrome Clinical Trial

Official title:

Bacterial Overgrowth Associated With Chronic Multisymptom Illness Complex

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00956150
• Other study ID #: HRRC 07-155
• Status: Recruiting
• Phase: Phase 1
• First received: August 10, 2009
• Last updated: April 30, 2013
• Start date: April 2009

Study information

• Verified date: April 2013
• Source: New Mexico VA Healthcare System
• Contact: Natalie R Mills, BS
• Phone: 505-265-1711
• Email: Natalie.Mills[@]va.gov
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Stated: Department of Defense (DoD)United States: Central Data Monitoring Committee (CDMC)United States: VA Merit ReviewUnited States: Human Research Review CommitteeUnited States: VA Research and Development Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gulf War Syndrome
• Persian Gulf Syndrome

Intervention

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
Placebo TID PO x 10 days

Locations

Country	Name	City	State
United States	New Mexico VA Healthcare System	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
Henry C. Lin, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the pattern of bacterial gas excretion in breath among Veterans with Gulf War Syndrome vs. Controls using Lactulose Breath Test		every 15 minutes for 180 minutes	No
Primary	To determine the response to antibiotic treatment in Gulf War Syndrome patients.		Two weeks	No