Could a gut supplement ease gulf war illness symptoms?
NCT ID NCT05367245
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial is testing whether a butyrate supplement (Cal-Mag Butyrate) can improve physical function in 120 veterans with Gulf War Illness. The study also looks at effects on fatigue, memory, gut health, and inflammation. Participants take the supplement or a placebo for several weeks, and researchers measure changes using health surveys and cognitive tests.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Calcium-Magnesium Butyrate (a dietary supplement)
- What this could lead to
- If it works, this could point toward a treatment that improves physical function and reduces fatigue, gut issues, and cognitive problems in veterans with Gulf War Illness.
- What could go wrong
- This is a mid-stage trial with only 120 participants, so results may not apply to all veterans. The supplement may not work better than a placebo, and side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Gulf war era veteran deployed 40 and 70 years old, in good health by medical history prior to 1990 meeting GWI case definition of CDC and Kansas criteria and * currently have no exclusionary diagnoses (self- reported) that could reasonably explain the symptoms of their fatiguing illness. The severity of illness is moderate to severe, scoring less than 30 of 100 on the physical domain of VSF36 . Exclusion Criteria: * Untreated schizophrenia, * Untreated bipolar disorder, * Untreated delusional disorders, * Untreated dementias of any type and * active alcoholism or drug abuse. * Medical conditions excluded include (i) organ failure, (ii) defined rheumatologic inflammatory disorders, and (iii) transplant. * Use of Butyrate in any form in the 3 months prior to study drug, medications that would impact gut motility, diarrhea, chronic pain, and immune function e.g., steroids, (Last 3 months) * immunosuppressive drugs or biologic response modifiers within 3 months of study entry will be used as exclusion criteria. * Pregnancy, or planned pregnancy in the next 6 months, * Body mass index more than 35 * Specific diets that may have enhanced or enriched fiber or butyrogenic formulations (FODMAP) * Medications that could potentially impact immune function in the past one month will be excluded (e.g., steroids, antibiotics, immunosuppressives; * Medications containing supplement calcium or magnesium butyrate should not be taken for at least 3 months before study entry. * Nutraceuticals that are formulated to impact gut microbiome or immune health) and use of drugs that affect GI motility and use of any antibiotic in the last 2 months. * Known allergy to butyrate supplements or their derivatives such as sodium salts or hydroxy derivatives of butyrate and/or inactive ingredients of active and placebo soft gelatin will also be excluded. * Current evidence of celiac disease or late-stage cirrhosis of the liver, Giardia antigen presence, Clostridium difficile toxin in stool, tissue transglutaminase antibody, recent change in gastrointestinal medications, use of drugs that affects gastrointestinal motility, and use of any antibiotic in the last two months also will be excluded.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Miami VA Healthcare System, Miami, FL
RECRUITINGMiami, Florida, 33125, United States
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VA Long Beach Healthcare System, Long Beach, CA
RECRUITINGLong Beach, California, 90822, United States
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VA Salt Lake City Health Care System, Salt Lake City, UT
RECRUITINGSalt Lake City, Utah, 84148-0001, United States
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Other studies related to the condition(s) this trial covers.
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- Gulf war Veterans' brain blood flow under the microscope
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