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Prebiotic Supplement

Resistant Potato Starch for Gulf War Syndrome

Phase 2

Waitlist Available

Led By Nasia Safdar, MD PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial will study the effects of a dietary fiber supplement on Gulf War illness, which affects 25-32% of veterans from the First Gulf War. It will look at how the supplement impacts pain, fatigue, skin & respiratory issues.

Who is the study for?

This trial is for Veterans aged 45-80 with moderate to severe Gulf War Illness (GWI) symptoms, including pain, gastrointestinal issues, and fatigue. Participants must be able to consent, take oral medication, provide samples, and comply with study procedures for the duration of the study. Smokers, heavy drinkers, pregnant women or those planning pregnancy are excluded.Check my eligibility

What is being tested?

The trial is testing Resistant Potato Starch as a dietary fiber prebiotic supplement to improve life quality in Veterans by targeting gut microbiota alterations associated with GWI. The effectiveness will be measured through changes in health-related quality of life indicators.See study design

What are the potential side effects?

While not explicitly stated here, potential side effects may include digestive discomfort such as bloating or gas due to increased fiber intake from the Resistant Potato Starch.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Secondary outcome measures

Changes in GWI symptoms over the study period

Changes in overall health over the study period

Improvement in quality of life

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Prebiotic armExperimental Treatment1 Intervention

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.

Group II: Standard dietActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Resistant Potato Starch

2019

N/A

~80

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,551 Total Patients Enrolled

1 Trials studying Gulf War Syndrome

128 Patients Enrolled for Gulf War Syndrome

Nasia Safdar, MD PhDPrincipal InvestigatorWilliam S. Middleton Memorial Veterans Hospital, Madison, WI

5 Previous Clinical Trials

11,200 Total Patients Enrolled

Media Library

Resistant Potato Starch (Prebiotic Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05820893 — Phase 2

Gulf War Syndrome Research Study Groups: Prebiotic arm, Standard diet

Gulf War Syndrome Clinical Trial 2023: Resistant Potato Starch Highlights & Side Effects. Trial Name: NCT05820893 — Phase 2

Resistant Potato Starch (Prebiotic Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05820893 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial permit enrollment from individuals below the age of 35?

"According to the eligibility criteria, individuals must be between 45 and 80 years of age in order to take part in this research."

Answered by AI

Has the Prebiotic arm drug been sanctioned by the FDA?

"From our research, the Prebiotic arm was rated a 2 due to a lack of clinical evidence establishing its efficacy but some data pointing towards safety."

Answered by AI

Are there still opportunities for individuals to participate in this trial?

"Per clinicaltrials.gov, this medical trial is not currently accepting participants. The original posting date was August 1st 2023 and the last update occured on April 6th 2023. Nonetheless, 11 other trials are actively searching for patients at this moment in time."

Answered by AI

Who is most qualified to join this medical research experiment?

"This medical trial seeks to enrol 52 individuals aged 45-80 with Gulf War Syndrome. To be considered, patients must have experienced moderate to grave symptoms within at least three of the following six categories: joint/muscle pain, gastrointestional issues, respiratory ailments, skin conditions, fatigue and cognitive impairments for a minimum period of 6 months."

Answered by AI

What are the main goals of this experiment?

"The primary aim of this two-year clinical trial is to record changes in the levels of short-chain fatty acids and other gut microbiome metabolites. Further, it will assess alterations in GWI symptoms using a specified assessment tool, people's overall health by utilizing the VR-36 questionnaire, as well as determining how tolerable MSPrebiotic orally administered probiotics are via monitoring discontinuations due to adverse events."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Resistant Potato Starch to Alleviate GWI

2024. "Resistant Potato Starch to Alleviate GWI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05820893.