Resistant Potato Starch to Alleviate GWI
ConditionGulf War Illness
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50-85
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
Qualifiers
Ability to provide informed written consent
Willing to comply with all study procedures and be available for the duration of the study (including providing stool samples)
Meeting the modified Kansas GWI case definition* with gut symptoms endorsed
Deployed to Persian Gulf during Operations Desert Storm or Desert Shield56.Aged 50-85 years old
Disqualifiers
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.
Subjects identified as, or appearing to, lack consent capacity
Alcohol abuse (greater than 14 drinks per week for men and 7 drinks per week for women)
Use of investigational drugs, biologics, or devices within 30 days prior to randomization.
Trial design
Treatments tested in this trial
- Resistant Potato Starch
Treatment groups
52 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov