Gulf War SyndromePhase 1NCT00956150
Bacterial Overgrowth Associated With Chronic Multisymptom Illness Complex
A Phase 1 study testing Lactulose Breath Test and Rifaximin in people with Gulf War Syndrome, run by Henry C. Lin, MD at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gulf War Syndrome
- What is being tested?
- Lactulose Breath Test and Rifaximin
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Mar 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
New Mexico VA Healthcare System
Albuquerque, New Mexico, 87108
Natalie R Mills, BS, 505-265-1711 ext. 2286, Natalie.Mills@va.gov
Henry C Lin, MD, 505-265-1711 ext. 4511, helin@salud.unm.edu
About this study
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.
Read the 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.
- Conditions
- Gulf War Syndrome
- Being tested
- Lactulose Breath Test, Rifaximin, Placebo
- Keywords
- Chronic Multisymptom Complex, Small Intestinal Bacterial Overgrowth, Gulf War Syndrome, Chronic Multisymptom Illness Complex
- Medical subject headings
- Persian Gulf Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactulose Breath TestProcedure or surgery
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).
RifaximinDrug
Rifaximin 600 mg three times a day by mouth (TID PO) x 10 days
PlaceboDrug
Placebo TID PO x 10 days
| Study group | Role | What they receive |
|---|---|---|
| 60 GWS Rifaximin | Active comparator | Not described Receives: Procedure: Lactulose Breath Test; Drug: Rifaximin |
| 60 GWS Placebo | Placebo comparator | Not described Receives: Procedure: Lactulose Breath Test; Drug: 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. Receives: Procedure: Lactulose Breath Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the pattern of bacterial gas excretion in breath among Veterans with Gulf War Syndrome vs. Controls using Lactulose Breath Test
Measured: every 15 minutes for 180 minutes
To determine the response to antibiotic treatment in Gulf War Syndrome patients.
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2009 (estimated)
- Study startApr 2009
- Primary completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gulf War SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry C. Lin, MD
- Sponsor type
- US federal agency
- Responsible party
- Sponsor-investigator, Henry C. Lin, MD, New Mexico VA Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00956150
- Sponsor's protocol ID
- HRRC 07-155
- Status last verified
- Apr 2013
- First submitted
- 10 Aug 2009
- Last updated
- 1 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Overgrowth Associated With Chronic Multisymptom Illness Complex
- ClinicalTrials.gov ID
- NCT00956150
- Acronym / sponsor ID
- HRRC 07-155
- Conditions
- Gulf War Syndrome
- Keywords
- Chronic Multisymptom Complex, Small Intestinal Bacterial Overgrowth, Gulf War Syndrome, Chronic Multisymptom Illness Complex
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Henry C. Lin, MDUS federal agency
- Study start
- Apr 2009
- Primary completion
- Mar 2014 (estimated)
- First posted
- 11 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 60 GWS Rifaximin | Active comparator | Procedure: Lactulose Breath Test, Drug: Rifaximin |
| 60 GWS Placebo | Placebo comparator | Procedure: Lactulose Breath Test, Drug: Placebo |
| Healthy Control | Experimental | Procedure: Lactulose Breath TestPatient is a healthy control and will not be on study intervention. Asked to perform Lactulose Breath Test to compare results with GWS patients. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactulose Breath TestTest 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). | Procedure or surgery | 60 GWS Placebo, 60 GWS Rifaximin, Healthy Control |
| RifaximinRifaximin 600 mg three times a day by mouth (TID PO) x 10 days | Drug | 60 GWS Rifaximin |
| PlaceboPlacebo TID PO x 10 days | Drug | 60 GWS Placebo |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lactulose Breath Test and Rifaximin in people with Gulf War Syndrome, run by Henry C. Lin, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natalie R Mills, BS (505-265-1711 ext. 2286, Natalie.Mills@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2013; AzTrials last refreshed its copy on 30 Oct 2026.