Gulf War IllnessPhase 2NCT05820893
Resistant Potato Starch to Alleviate GWI
A Phase 2 study testing Resistant Potato Starch in people with Gulf War Illness, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Gulf War Illness
- What is being tested?
- Resistant Potato Starch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2025to 30 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- Gastrointestinal (diarrhea, nausea, vomiting, cramping)
- Respiratory (persistent cough, wheezing)
- Skin (rashes)
- Fatigue (sleep problems, fatigue)
- Neurologic (memory problems, headaches, dizziness, mood changes)
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, 53705-2254
Nasia Safdar, MD PhD, 608-280-7007, Nasia.Safdar@va.gov
Nasia Safdar, MD PhD
About this study
Official title: BCCMA: Targeting Gut-Microbiome in Veterans Deployment Related Gastrointestinal and Liver Diseases; CMA5- Functional Metagenomics in GWI-related Gut Dysfunction
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.
Read the detailed description
Background: Despite medical advancements, Gulf War illness (GWI) treatment remains a major challenge. Gulf war veterans with GWI can experience acute or chronic disorders of diarrhea, nausea, joint pain, muscle pain, general fatigue, sleep problems skin rashes, wheezing, persistent cough, dizziness and headaches. It is estimated 25-32% of the over 700,000 coalition troops deployed report symptoms consistent with GWI, 47% of whom experience gut-related symptoms. Longitudinal studies have shown little to no overall improvement in symptoms over time. Currently there are very limited treatment courses for GWI and even fewer for gut-related symptoms leading to the advisory committee on GWIs call for research leading to effective treatments improving the health of GWVs. Studies have shown that the gut is comprised of diverse bacteria that plays a critical role in the health of an individual. Comprised gut microbiota can lead to serious consequences such as GWI. There is thus a critical need to identify a new treatment that is safe, effective with minimal adverse effect to reduce GWI-associated morbidity. Prebiotics are such an example. Prebiotics are natural fibers derived from carbohydrates and can be beneficial to gut microbiota (good bacterial in the gut). Resistant starches (RS) are dietary fiber prebiotics found naturally in many foods including potatoes, plantains, and legumes. In addition to being highly accessible, RS have been shown to be well tolerated with few adverse reactions. While no studies of RS exist in GWI patients, a meta-analysis of RS in IBD has shown RS to be an effective treatment in both animal and clinical studies where improvements in clinical remission and reduced mucosal damage were found. Furthermore, numerous studies have found RS to reduce inflammation in murine models of colonic inflammation and to modify the intestinal microbiota and associated metabolome in mice and swine.
Objectives: The investigators hypothesize those randomized to the RS prebiotic group will experience a reduction in GWI symptoms following the completion of the trial. The investigators also hypothesize the prebiotic group will have increased concentrations of SCFAs and SCFA-producing bacteria in the gut compared to those in the control group.
Methods: This is a phase II randomized clinical trial in Veterans with GWI experiencing gut symptoms. Subjects will be randomized to either taking a RS prebiotic daily for 4 weeks or to the control group (maintenance of normal diet). Subjects will provide stool and serum samples as well as complete a series of health history and dietary questionnaires.
- Conditions
- Gulf War Illness
- Being tested
- Resistant Potato Starch
- Keywords
- Persian Gulf Syndrome, Gulf War Illness, Veterans, Gastrointestinal Microbiome
- Medical subject headings
- Persian Gulf Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistant Potato StarchDrug
Also called MSPrebiotic
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Resistant Potato Starch |
| Standard diet | No intervention | Subjects randomized to this arm will be asked to maintain their usual diet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 2 years
Secondary outcomes (4)
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start3 Feb 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gulf War IllnessStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized to either maintaining their standard diet or taking the resistant potato starch prebiotic for 4 weeks.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Nasia Safdar, MD PhD, Principal investigator, William S. Middleton Memorial Veterans Hospital, Madison, WI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820893
- Sponsor's protocol ID
- SPLD-004-22S
- Other IDs
- CX002471
- Status last verified
- May 2026
- First submitted
- 10 Mar 2023
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: A BioProject will be created with NCBI and sequencing data will be shared there with a limited, deidentified set of metadata from participants. Additional data can be obtained from the research team with permissions.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BCCMA: Targeting Gut-Microbiome in Veterans Deployment Related Gastrointestinal and Liver Diseases; CMA5- Functional Metagenomics in GWI-related Gut Dysfunction
- ClinicalTrials.gov ID
- NCT05820893
- Acronym / sponsor ID
- SPLD-004-22S
- Conditions
- Gulf War Illness
- Keywords
- Persian Gulf Syndrome, Gulf War Illness, Veterans, Gastrointestinal Microbiome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: Despite medical advancements, Gulf War illness (GWI) treatment remains a major challenge. Gulf war veterans with GWI can experience acute or chronic disorders of diarrhea, nausea, joint pain, muscle pain, general fatigue, sleep problems skin rashes, wheezing, persistent cough, dizziness and headaches. It is estimated 25-32% of the over 700,000 coalition troops deployed report symptoms consistent with GWI, 47% of whom experience gut-related symptoms. Longitudinal studies have shown little to no overall improvement in symptoms over time. Currently there are very limited treatment courses for GWI and even fewer for gut-related symptoms leading to the advisory committee on GWIs call for research leading to effective treatments improving the health of GWVs. Studies have shown that the gut is comprised of diverse bacteria that plays a critical role in the health of an individual. Comprised gut microbiota can lead to serious consequences such as GWI. There is thus a critical need to identify a new treatment that is safe, effective with minimal adverse effect to reduce GWI-associated morbidity. Prebiotics are such an example. Prebiotics are natural fibers derived from carbohydrates and can be beneficial to gut microbiota (good bacterial in the gut). Resistant starches (RS) are dietary fiber prebiotics found naturally in many foods including potatoes, plantains, and legumes. In addition to being highly accessible, RS have been shown to be well tolerated with few adverse reactions. While no studies of RS exist in GWI patients, a meta-analysis of RS in IBD has shown RS to be an effective treatment in both animal and clinical studies where improvements in clinical remission and reduced mucosal damage were found. Furthermore, numerous studies have found RS to reduce inflammation in murine models of colonic inflammation and to modify the intestinal microbiota and associated metabolome in mice and swine.
Objectives: The investigators hypothesize those randomized to the RS prebiotic group will experience a reduction in GWI symptoms following the completion of the trial. The investigators also hypothesize the prebiotic group will have increased concentrations of SCFAs and SCFA-producing bacteria in the gut compared to those in the control group.
Methods: This is a phase II randomized clinical trial in Veterans with GWI experiencing gut symptoms. Subjects will be randomized to either taking a RS prebiotic daily for 4 weeks or to the control group (maintenance of normal diet). Subjects will provide stool and serum samples as well as complete a series of health history and dietary questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized to either maintaining their standard diet or taking the resistant potato starch prebiotic for 4 weeks.
| Arm | Type | Receives |
|---|---|---|
| Prebiotic arm | Experimental | Drug: Resistant Potato StarchSubjects 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. |
| Standard diet | No intervention | –Subjects randomized to this arm will be asked to maintain their usual diet. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistant Potato StarchAlso: MSPrebioticMSPrebiotic (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. | Drug | Prebiotic arm |
Primary outcome
Changes from baseline to the end of the study period in the composition of the gut microbiome
Time frame: 2 years
The gut microbiome will be assessed using next generation sequencing (shotgun metagenomics)
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
The metabolites in the gut will be identified through next-generation sequencing technology and both targeted and untargeted metabolomics.
4 secondary outcomes
Improvement in quality of life
Time frame: 2 years
Changes in GWI symptoms over the study period
Time frame: 2 years
Changes in overall health over the study period
Time frame: 2 years
Tolerability of the probiotic defined as discontinuation due to adverse events during the study period
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Yes. A BioProject will be created with NCBI and sequencing data will be shared there with a limited, deidentified set of metadata from participants. Additional data can be obtained from the research team with permissions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nasia Safdar, MD PhD principal investigator
William S. Middleton Memorial Veterans Hospital, Madison, WI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Resistant Potato Starch in people with Gulf War Illness, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nasia Safdar, MD PhD ((608) 280-7007, Nasia.Safdar@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline to the end of the study period in the composition of the gut microbiome (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026; AzTrials last refreshed its copy on 31 Oct 2026.