💬In plain words
What the trial is, and whether it could suit you
Gulf War Illness (GWI) affects an estimated 25-32% of the over 700,000 coalition troops deployed to the Persian Gulf as part of the First Gulf War. GWI causes a range of pain, fatigue, gastrointestinal, skin, neurologic, and respiratory symptoms. New treatments to reduce GWI-associated morbidity are critically needed. Research suggests a role for the gastrointestinal microbiome in mediating health, including through impacting metabolism and immunity. The disruption of this microbiome plays a role in multiple diseases, and preliminary data suggest that Veterans with GWI have altered gut microbiota. The investigators will evaluate the effectiveness of a dietary fiber prebiotic supplement intervention on improving the quality of life of Veterans with GWI.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1. Ability to provide informed written consent
2. Willing to comply with all study procedures and be available for the duration of the study (including providing stool samples)
3. Meeting the modified Kansas GWI case definition\* with gut symptoms endorsed
4. Deployed to Persian Gulf during Operations Desert Storm or Desert Shield56.Aged 50-85 years old
* Moderate to severe GWI symptoms lasting at least 6 months in a minimum of three of the six symptom domains (one of which must be fatigue). The symptom domains are:
* Pain (joint pain, muscle pain)
* Gastrointestinal (diarrhea, nausea, vomiting, cramping)
* Respiratory (persistent cough, wheezing)
* Skin (rashes)
* Fatigue (sleep problems, fatigue)
* Neurologic (memory problems, headaches, dizziness, mood changes)
Exclusion Criteria:
1. A Known SARS-CoV-2 infection in the last 60 days and/or with a diagnosis of post-acute sequelae of COVID-19 (PASC, sometimes called long COVID) defined as COVID-19 symptoms lasting for greater than 6 months.
2. Subjects identified as, or appearing to, lack consent capacity
3. Alcohol abuse (greater than 14 drinks per week for men and 7 drinks per week for women)
4. Use of investigational drugs, biologics, or devices within 30 days prior to randomization.
5. Individuals who are pregnant, lactating or planning on becoming pregnant during the study.
6. Diagnosed inflammatory bowel disease, Crohn's disease, or Celiac's disease
7. Uncontrolled/untreated hypothyroidism
8. Previous gastrointestinal surgery (colorectal surgery, gastric bypass, intestinal resection)
9. Systemic antibiotics in the last 30 days
10. Fecal microbiota transplant in the last 30 days
11. Active dysphagia
12. Allergies to any of the ingredients in MSPrebiotic
13. Use of immunomodulatory medications in the last 30 days
14. Any other factor, condition, or medication not listed above the Investigators believe will affect the response in the gut or the interpretation of results.
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