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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 60 GWS Rifaximin | Active Comparator |
| |
| 60 GWS Placebo | Placebo Comparator |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactulose Breath Test | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natalie R Mills, BS | Contact | 505-265-1711 | 2286 | Natalie.Mills@va.gov |
| Henry C Lin, MD | Contact | 505-265-1711 | 4511 | helin@salud.unm.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Mexico VA Healthcare System | Recruiting | Albuquerque | New Mexico | 87108 | United States |
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| ID | Term |
|---|---|
| D018923 | Persian Gulf Syndrome |
| ID | Term |
|---|---|
| D009784 | Occupational Diseases |
| D000067398 | War-Related Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D000078262 | Rifaximin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Rifaximin | Drug | Rifaximin 600 mg three times a day by mouth (TID PO) x 10 days |
|
| Placebo | Drug | Placebo TID PO x 10 days |
|
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |