Resistant Potato Starch to Alleviate GWI

NCT05820893 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: SPLD-004-22SCX002471
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Gulf War Illness

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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)

  2 years

• 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.

  2 years

Secondary Outcomes (4)

• Improvement in quality of life

  2 years

• Changes in GWI symptoms over the study period

  2 years

• Changes in overall health over the study period

  2 years

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

  2 years

Study Arms (2)

Prebiotic arm

EXPERIMENTAL

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.

Drug: Resistant Potato Starch

Standard diet

NO INTERVENTION

Subjects randomized to this arm will be asked to maintain their usual diet.

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.

Also known as: MSPrebiotic

Prebiotic arm

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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:
• Pain (joint pain, muscle pain)
• Gastrointestinal (diarrhea, nausea, vomiting, cramping)
• Respiratory (persistent cough, wheezing)
• Skin (rashes)
• Fatigue (sleep problems, fatigue)
• Neurologic (memory problems, headaches, dizziness, mood changes)

You may not qualify if:

• 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.
• Individuals who are pregnant, lactating or planning on becoming pregnant during the study.
• Diagnosed inflammatory bowel disease, Crohn's disease, or Celiac's disease
• Uncontrolled/untreated hypothyroidism
• Previous gastrointestinal surgery (colorectal surgery, gastric bypass, intestinal resection)
• Systemic antibiotics in the last 30 days
• Fecal microbiota transplant in the last 30 days
• Active dysphagia
• Allergies to any of the ingredients in MSPrebiotic
• Use of immunomodulatory medications in the last 30 days
• Any other factor, condition, or medication not listed above the Investigators believe will affect the response in the gut or the interpretation of results.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, 53705-2254, United States

RECRUITING

MeSH Terms

Conditions

Persian Gulf Syndrome

Condition Hierarchy (Ancestors)

Occupational Diseases; War-Related Injuries; Wounds and Injuries

Study Officials

• Nasia Safdar, MD PhD

  William S. Middleton Memorial Veterans Hospital, Madison, WI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nasia Safdar, MD PhD

CONTACT

(608) 280-7007; Nasia.Safdar@va.gov

Julie A Keating, PhD

CONTACT

(608) 256-1901; julie.keating@va.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized to either maintaining their standard diet or taking the resistant potato starch prebiotic for 4 weeks.

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: April 20, 2023
• Study Start: February 3, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: 3 years
• Access Criteria: Written requests for access to the data will be accepted. Data and documentation will be available under a data use agreement (DUA) that provides a commitment to use data for research purposes only, not to attempt to identify participants, to secure data using appropriate computer technology, and to destroy/return data after analyses are complete.

Locations

US (1)