Recruiting
Phase 2

Dietary Fiber

Sponsor:

VA Office of Research and Development

Code:

NCT05820893

Conditions

Gulf War Illness

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Resistant Potato Starch

Study Details

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

Study ID

NCT05820893

Start date

Feb 3, 2025

Status verified date

May, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Ability to provide informed written consent
2. Willing to comply with all study procedures and be available for the duration of the study (including providing stool samples)
3. Meeting the modified Kansas GWI case definition\* with gut symptoms endorsed
4. 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)

Exclusion Criteria:

1. 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.
2. Subjects identified as, or appearing to, lack consent capacity
3. Alcohol abuse (greater than 14 drinks per week for men and 7 drinks per week for women)
4. Use of investigational drugs, biologics, or devices within 30 days prior to randomization.
5. Individuals who are pregnant, lactating or planning on becoming pregnant during the study.
6. Diagnosed inflammatory bowel disease, Crohn's disease, or Celiac's disease
7. Uncontrolled/untreated hypothyroidism
8. Previous gastrointestinal surgery (colorectal surgery, gastric bypass, intestinal resection)
9. Systemic antibiotics in the last 30 days
10. Fecal microbiota transplant in the last 30 days
11. Active dysphagia
12. Allergies to any of the ingredients in MSPrebiotic
13. Use of immunomodulatory medications in the last 30 days
14. Any other factor, condition, or medication not listed above the Investigators believe will affect the response in the gut or the interpretation of results.

Study Design

Enrollment

52 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Resistant Potato Starch

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Nasia Safdar, MD PhD

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

Julie A Keating, PhD

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

Locations

William S. Middleton Memorial Veterans Hospital, Madison, WI

Recruiting

Madison, Wisconsin, United States, 53705-2254

Contacts

Nasia Safdar, MD PhD

608-280-7007Nasia.Safdar@va.gov

Principal Investigator:

Nasia Safdar, MD PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

May 6, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-05-06.