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New treatment option for Gulf War Illness
Official title Resistant Potato Starch to Alleviate GWI
ClinicalTrials.gov ID: NCT05820893
What this study is testing
What is Resistant Potato Starch?
Resistant Potato Starch is an investigational medicine, given as an once-daily, being studied as a potential treatment for gulf war illness.
Also referred to as MSPrebiotic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 85
You may be able to join 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...
You likely can't join 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)...
- people 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
See the full eligibility criteria
- 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)
- 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.
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madison, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.