Resistant Potato Starch to Alleviate GWI

Description

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.

Conditions

Gulf War Illness

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Study Overview

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Study Details

Study overview

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.

BCCMA: Targeting Gut-Microbiome in Veterans Deployment Related Gastrointestinal and Liver Diseases; CMA5- Functional Metagenomics in GWI-related Gut Dysfunction

Resistant Potato Starch to Alleviate GWI

Condition
Gulf War Illness
Intervention / Treatment

-

Contacts and Locations

Madison

William S. Middleton Memorial Veterans Hospital, Madison, WI, Madison, Wisconsin, United States, 53705-2254

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 3. Ability to take oral medication.
  • 4. Willing to provide blood and stool samples
  • 5. Meeting the modified Kansas GWI case definition\* with gut symptoms endorsed
  • 6. Aged 45-80 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)
  • 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. Current smokers
  • 4. Alcohol abuse (greater than 14 drinks per week for men and 7 drinks per week for women)
  • 5. Use of investigational drugs, biologics, or devices within 30 days prior to randomization.
  • 6. Individuals who are pregnant, lactating or planning on becoming pregnant during the study.
  • 7. Diagnosed inflammatory bowel disease, Crohn's disease, or Celiac's disease
  • 8. Hypothyroidism
  • 9. Unstable psychiatric illness
  • 10. Involvement in another clinical trial
  • 11. Previous gastrointestinal surgery (colorectal surgery, gastric bypass, intestinal resection)
  • 12. Use of other prebiotics, probiotics (including yogurt containing live probiotics), postbiotics, or other fiber supplements in the last 30 days
  • 13. Systemic antibiotics in the last 30 days
  • 14. Fecal microbiota transplant in the last 30 days
  • 15. Active dysphagia
  • 16. Allergies to any of the ingredients in MSPrebiotic
  • 17. Individuals with a Kansas criteria exclusionary condition: lupus, multiple sclerosis, schizophrenia, active cancer treatment, physical impairment related to a stroke, uncontrolled Diabetes Mellitus
  • 18. Use of anti-diarrheal agents, stool softeners, or immunomodulatory medications in the last 30 days.
  • 19. The use of proton pump inhibitors, H2 receptor blockers or any other medication known to suppress gastric acid in the last 30 days.
  • 20. Any other factor, condition, or medication not listed above the Investigators believe will affect the response in the gut or the interpretation of results.

Ages Eligible for Study

45 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

VA Office of Research and Development,

Nasia Safdar, MD PhD, PRINCIPAL_INVESTIGATOR, William S. Middleton Memorial Veterans Hospital, Madison, WI

Study Record Dates

2026-08-03