NCT00956150

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 11, 2009

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Last Updated

May 1, 2013

Status Verified

April 1, 2013

Enrollment Period

4.9 years

First QC Date

August 10, 2009

Last Update Submit

April 30, 2013

Conditions

Gulf War Syndrome

Keywords

Chronic Multisymptom ComplexSmall Intestinal Bacterial OvergrowthGulf War SyndromeChronic Multisymptom Illness Complex

Outcome Measures

Primary Outcomes (2)

  • 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

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

    Two weeks

Study Arms (3)

60 GWS Rifaximin

ACTIVE COMPARATOR
Procedure: Lactulose Breath TestDrug: Rifaximin

60 GWS Placebo

PLACEBO COMPARATOR
Procedure: Lactulose Breath TestDrug: Placebo

Healthy Control

EXPERIMENTAL

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

Interventions

Lactulose Breath TestPROCEDURE

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).

60 GWS Placebo60 GWS RifaximinHealthy Control
RifaximinDRUG

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

60 GWS Rifaximin
PlaceboDRUG

Placebo TID PO x 10 days

60 GWS Placebo

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New Mexico VA Healthcare System

Albuquerque, New Mexico, 87108, United States

RECRUITING

MeSH Terms

Conditions

Persian Gulf Syndrome

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Occupational DiseasesWar-Related InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

RifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Central Study Contacts

Natalie R Mills, BS

CONTACT

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

Henry C Lin, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Henry C. Lin, MD

Study Record Dates

First Submitted

August 10, 2009

First Posted

August 11, 2009

Study Start

April 1, 2009

Primary Completion

March 1, 2014

Last Updated

May 1, 2013

Record last verified: 2013-04

Locations

US(1)