Actively Recruiting

Phase 2
Age: 50Years - 85Years
All Genders
NCT05820893

Resistant Potato Starch to Alleviate GWI

Led by VA Office of Research and Development · Updated on 2026-05-06

52

Participants Needed

1

Research Sites

177 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

Resistant Potato Starch to Alleviate GWI

Who Can Participate

Age: 50Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to provide informed written consent
  • Willingness to comply with all study procedures and provide stool samples
  • Meeting the modified Kansas Gulf War Illness case definition with gut symptoms
  • Deployed to the Persian Gulf during Operations Desert Storm or Desert Shield
  • Aged between 50 and 85 years old
Not Eligible

You will not qualify if you...

  • Known COVID-19 infection in the last 60 days or long COVID symptoms lasting more than 6 months
  • Unable or unwilling to provide consent
  • Alcohol abuse (more than 14 drinks per week for men, 7 drinks per week for women)
  • Use of investigational drugs, biologics, or devices within 30 days before randomization
  • Pregnant, lactating, or planning pregnancy during the study
  • Diagnosed inflammatory bowel disease, Crohn's disease, or Celiac's disease
  • Uncontrolled or untreated hypothyroidism
  • Previous gastrointestinal surgery (colorectal surgery, gastric bypass, intestinal resection)
  • Systemic antibiotics within 30 days
  • Fecal microbiota transplant within 30 days
  • Active difficulty swallowing (dysphagia)
  • Allergies to any ingredients in MSPrebiotic
  • Use of immunomodulatory medications within 30 days
  • Any condition or medication that could affect gut response or study results as judged by investigators

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, United States, 53705-2254

Actively Recruiting

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Research Team

N

Nasia Safdar, MD PhD

CONTACT

J

Julie A Keating, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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