Resistant Potato Starch to Alleviate GWI

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
VA Office of Research and Development
Study ID
NCT05820893
Phase
PHASE2
Status
Recruiting
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Conditions

  • Gulf War Illness

Eligibility Criteria

Sex
ALL
Age
50 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Resistant Potato Starch — DRUG
    MSPrebiotic (MSPrebiotic Inc, Carberry, Manitoba, Canada). MSPrebiotic is an unmodified resistant starch derived from potatoes (Solanar tuberosum). It consists of 20% amylose and 80% amylopectin forming granules the stomach and small intestine are unable to digest allowing for absorption in the colon. MSPrebiotic is consumed by mixing 10g into cold or room temperature foods or beverages; it is not to be heated. Participants will be instructed to take MSPrebiotic 2 or more hours before or after consuming any medications.

Study Details

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.

Key Dates

Start date
Feb 3, 2025
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Prebiotic arm
    Subjects will consume the RS prebiotic daily for 4 weeks. A dose escalation will be used with subjects taking 4g of the prebiotic for the first 4 days, 7g the next 3 days and the full dose of 10g on day 8.
  • No Intervention: Standard diet
    Subjects randomized to this arm will be asked to maintain their usual diet.

Primary Outcome Measure

Changes from baseline to the end of the study period in the composition of the gut microbiome [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
William S. Middleton Memorial Veterans Hospital, Madison, WIMadisonWisconsin53705-2254
Nasia Safdar, MD PhD
[email protected]
608-280-7007
Nasia Safdar, MD PhD (PRINCIPAL_INVESTIGATOR)

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By research site
William S. Middleton Memorial Veterans Hospital, Madison, WI· Madison, WI

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