Resistant Potato Starch to Alleviate GWI

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Apr 6, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a special type of dietary fiber called resistant potato starch to help improve the health and quality of life for veterans suffering from Gulf War Illness (GWI). GWI affects many veterans, causing a mix of symptoms like pain, fatigue, and gastrointestinal issues. Researchers believe that the bacteria in our gut, known as the microbiome, may play a role in these health problems. By giving participants a fiber supplement, the study aims to see if it can positively change their gut health and reduce GWI symptoms.

To join the study, participants need to be between 45 and 80 years old and have been experiencing moderate to severe GWI symptoms for at least six months. They should be able to provide consent, take oral supplements, and provide blood and stool samples. Participants will be closely monitored throughout the study and can expect to take the fiber supplement while sharing their experiences. However, certain conditions, such as recent COVID-19 infection or specific gastrointestinal diseases, may prevent someone from participating. This trial is currently recruiting, and it offers a potential new approach to help improve the lives of those affected by GWI.

Gender

ALL

Eligibility 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.
• • 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)
• 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. 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.