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Antibiotic

Rifaximin for Gulf War Syndrome

Phase 1
Waitlist Available
Research Sponsored by Henry C. Lin, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Gulf War Veterans meeting the 1994 CDC criteria for the diagnosis of Chronic Fatigue Syndrome (CFS)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two weeks
Awards & highlights

Study Summary

This trial will study whether gut bacteria may be responsible for symptoms associated with Gulf War Syndrome.

Who is the study for?
This trial is for Gulf War Veterans who've had symptoms like fatigue, mood/cognitive issues, or musculoskeletal pain for over six months. They must have been screened to rule out other illnesses and be under a doctor's care with a previous diagnosis of GWS. Healthy controls are also needed but must not show abnormal symptoms.Check my eligibility
What is being tested?
The study aims to see if gut bacteria cause Gulf War Syndrome by testing the Lactulose Breath Test and Rifaximin (an antibiotic) against a placebo in veterans with GWS compared to healthy individuals.See study design
What are the potential side effects?
Rifaximin may cause side effects such as digestive upset, headaches, dizziness, and an increased risk of infection. The Lactulose Breath Test is generally safe but can sometimes result in bloating or stomach discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a Gulf War Veteran diagnosed with Chronic Fatigue Syndrome.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 15 minutes for 180 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 15 minutes for 180 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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
To determine the response to antibiotic treatment in Gulf War Syndrome patients.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Healthy ControlExperimental Treatment1 Intervention
Patient is a healthy control and will not be on study intervention. Asked to perform Lactulose Breath Test to compare results with GWS patients.
Group II: 60 GWS RifaximinActive Control2 Interventions
Group III: 60 GWS PlaceboPlacebo Group2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lactulose Breath Test
2007
N/A
~200

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Henry C. Lin, MDLead Sponsor
1 Previous Clinical Trials
55 Total Patients Enrolled

Media Library

Rifaximin (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT00956150 — Phase 1
Gulf War Syndrome Research Study Groups: 60 GWS Rifaximin, 60 GWS Placebo, Healthy Control
Gulf War Syndrome Clinical Trial 2023: Rifaximin Highlights & Side Effects. Trial Name: NCT00956150 — Phase 1
Rifaximin (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00956150 — Phase 1
~13 spots leftby May 2025
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