Using resistant potato starch to help veterans with Gulf War Illness
BCCMA: Targeting Gut-Microbiome in Veterans Deployment Related Gastrointestinal and Liver Diseases; CMA5- Functional Metagenomics in GWI-related Gut Dysfunction
This study is testing if a special type of potato starch can help improve the gut health and overall quality of life for veterans dealing with Gulf War Illness.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT05820893 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a dietary fiber prebiotic supplement, specifically resistant potato starch, in improving the quality of life for veterans suffering from Gulf War Illness (GWI). GWI affects a significant portion of veterans, leading to various debilitating symptoms, particularly gastrointestinal issues. The study will involve participants who meet specific criteria, including having gut-related symptoms associated with GWI, and will require them to provide blood and stool samples. The intervention seeks to restore gut microbiota balance, which may alleviate some of the symptoms experienced by these veterans.
Who should consider this trial
Good fit: Ideal candidates for this study are veterans aged 45-80 who have been diagnosed with Gulf War Illness and experience gastrointestinal symptoms.
Not a fit: Patients who have had a known SARS-CoV-2 infection in the last 60 days or are experiencing post-acute sequelae of COVID-19 may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life for veterans suffering from Gulf War Illness by alleviating gastrointestinal and other related symptoms.
How similar studies have performed: While there is limited research specifically targeting GWI with prebiotics, studies on gut microbiota and dietary interventions have shown promise in other gastrointestinal conditions, suggesting potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Madison, Wisconsin
- William S. Middleton Memorial Veterans Hospital, Madison, WI — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Nasia Safdar, MD PhD — William S. Middleton Memorial Veterans Hospital, Madison, WI
- Study coordinator: Nasia Safdar, MD PhD
- Email: Nasia.Safdar@va.gov
- Phone: (608) 280-7007
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.