RECRUITING

Resistant Potato Starch to Alleviate GWI

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-02-03
Study Completion:2026-08-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05820893

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.

Ages Eligible for Study:45 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Ability to provide informed written consent
  2. 2. Willing to comply with all study procedures and be available for the duration of the study.
  3. 3. Ability to take oral medication.
  4. 4. Willing to provide blood and stool samples
  5. 5. Meeting the modified Kansas GWI case definition\* with gut symptoms endorsed
  6. 6. Aged 45-80 years old
  7. * 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:
  8. * Pain (joint pain, muscle pain)
  9. * Gastrointestinal (diarrhea, nausea, vomiting, cramping)
  10. * Respiratory (persistent cough, wheezing)
  11. * Skin (rashes)
  12. * Fatigue (sleep problems, fatigue)
  13. * Neurologic (memory problems, headaches, dizziness, mood changes)
  1. 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. 2. Subjects identified as, or appearing to, lack consent capacity
  3. 3. Current smokers
  4. 4. Alcohol abuse (greater than 14 drinks per week for men and 7 drinks per week for women)
  5. 5. Use of investigational drugs, biologics, or devices within 30 days prior to randomization.
  6. 6. Individuals who are pregnant, lactating or planning on becoming pregnant during the study.
  7. 7. Diagnosed inflammatory bowel disease, Crohn's disease, or Celiac's disease
  8. 8. Hypothyroidism
  9. 9. Unstable psychiatric illness
  10. 10. Involvement in another clinical trial
  11. 11. Previous gastrointestinal surgery (colorectal surgery, gastric bypass, intestinal resection)
  12. 12. Use of other prebiotics, probiotics (including yogurt containing live probiotics), postbiotics, or other fiber supplements in the last 30 days
  13. 13. Systemic antibiotics in the last 30 days
  14. 14. Fecal microbiota transplant in the last 30 days
  15. 15. Active dysphagia
  16. 16. Allergies to any of the ingredients in MSPrebiotic
  17. 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. 18. Use of anti-diarrheal agents, stool softeners, or immunomodulatory medications in the last 30 days.
  19. 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. 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.

Contacts and Locations

Study Contact

Nasia Safdar, MD PhD
CONTACT
(608) 280-7007
Nasia.Safdar@va.gov
Ashley E Kates, PhD
CONTACT
(608) 256-1907
ashley.kates@va.gov

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: VA Office of Research and Development

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-03
Study Completion Date2026-08-03

Study Record Updates

Study Start Date2025-02-03
Study Completion Date2026-08-03

Terms related to this study

Keywords Provided by Researchers

  • Persian Gulf Syndrome
  • Gulf War Illness
  • Veterans
  • Gastrointestinal Microbiome

Additional Relevant MeSH Terms

  • Gulf War Illness