Recruiting
Phase 1

Observational Study

Sponsor:

Henry C. Lin, MD

Code:

NCT00956150

Conditions

Gulf War Syndrome

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Lactulose Breath Test

Rifaximin

Placebo

Study Details

Brief 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.

Conditions

Gulf War Syndrome

Study ID

NCT00956150

Start date

Apr, 2009

Status verified date

Apr, 2013

Primary completion date

Mar, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

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

Enrollment

210 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 60 GWS Rifaximin

placebo comparator: 60 GWS Placebo

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.

Interventions

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).

Rifaximin

Rifaximin 600 mg three times a day by mouth (TID PO) x 10 days

Placebo

Placebo TID PO x 10 days

Primary outcome measure

  • 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 ]
  • To determine the response to antibiotic treatment in Gulf War Syndrome patients. [ Time Frame: Two weeks ]

Central Contacts and Locations

Central contacts

Natalie R Mills, BS

505-265-1711Natalie.Mills@va.gov

Henry C Lin, MD

505-265-1711helin@salud.unm.edu

Locations

New Mexico VA Healthcare System

Recruiting

Albuquerque, New Mexico, United States, 87108

Contacts

Natalie R Mills, BS

505-265-1711Natalie.Mills@va.gov

Henry C Lin, MD

505-265-1711helin@salud.unm.edu

Principal Investigator:

Henry C Lin, MD

More Information

Sponsor

Henry C. Lin, MD

Last update posted

May 1, 2013

Last verified

Apr, 2013

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Henry C. Lin, MD on 2013-05-01.