Using resistant potato starch to help veterans with Gulf War Illness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Exploring treatments for Gulf War Illness-related gastrointestinal symptoms

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• Identifying blood biomarkers for Gulf War Illness

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• Investigating Gulf War Illness in Veterans

  This study is trying to understand how Gulf War Illness affects veterans by comparing those who have it with those who don’t through a two-week health evaluation.

  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT05375812

• Butyrate treatment for Gulf War Illness

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• Testing Nicotinamide Riboside for Gulf War Illness

  This study is testing if taking Nicotinamide Riboside can help veterans with Gulf War Illness feel better by boosting their energy levels and improving symptoms like fatigue and memory problems.

  Recruiting at 2 sites Roskamp Institute Inc. · Fort Lauderdale, Florida and 1 other locations · NCT05243290

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.