Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: Prebiotic armExperimental treatment 1 intervention
Group B: Standard dietNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Changes from baseline to the end of the study period in the composition of the gut microbiome

The gut microbiome will be assessed using next generation sequencing (shotgun metagenomics)

Time frame
2 years
2

Changes from baseline to the end of the study period in the concentration of short-chain fatty acids and other metabolites identified in the gut microbiome

The metabolites in the gut will be identified through next-generation sequencing technology and both targeted and untargeted metabolomics.

Time frame
2 years

Secondary outcomes

1

Improvement in quality of life

Quality of life will be assessed using the Gastrointestinal Quality of Life Index (GIQLI) questionnaire from baseline to the end of the study period.

Time frame
2 years
2

Changes in GWI symptoms over the study period

A GWI symptoms assessment tool will be used to determine changes in symptoms from baseline to the end of the study period.

Time frame
2 years
3

Changes in overall health over the study period

The Veterans RAND-36 (VR-36) questionnaire will be used to determine changes in overall health and associated quality of life over the study period.

Time frame
2 years
4

Tolerability of the probiotic defined as discontinuation due to adverse events during the study period

Assess the tolerability of orally consuming MSPrebiotic by determining the frequency of withdraws from the study due to the occurrence of adverse events.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

Source ClinicalTrials.gov
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