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Ca-Mg Butyrate for Gulf War Illness

This study is testing whether a supplement called Cal-Mag Butyrate can improve the physical health of veterans suffering from Gulf War Illness (GWI). GWI is a chronic illness with multiple symptoms, including chronic fatigue and problems with thinking. Researchers believe that Cal-Mag Butyrate, which is a form of butyric acid, might help by restoring healthy gut bacteria. You may be able to join if you are a Gulf War era veteran between 40 and 70 years old, deployed between 1990-1991, and meet the GWI case definition. The study will measure changes in your physical functioning using a health survey over 20 weeks. The current recruitment status is unclear.

Study design
This is a randomized, double-blind, placebo-controlled Phase II study with two groups, involving 120 participants.
What's involved
Participants will take either Cal-Mag Butyrate capsules or a placebo twice a day for 18 weeks. There will be virtual follow-up visits after 20 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 20 weeks after starting treatment, with virtual visits.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05367245

Ca-Mg Butyrate in GWI

Recruiting
PHASE2Ages 40–70InterventionalTreatment
VA Office of Research and Development
~120 participants
Updated 2025-10-31 on ClinicalTrials.gov
What's tested:Cal-Mag ButyratePlacebo

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Veterans Short Form 36-Item Health Survey Physical Component Summary
Measured over Change from Baseline at 3, 6, 9, 12, 18 and 20 weeks

Conditions

Gulf War Illness
Chronic Fatigue
Neurocognitive Dysfunction

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Gulf war syndrome

NCT05367245

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Miami VA Healthcare System, Miami, FL

    Miami, Floridastudy coordinator listed

    Recruiting

  • VA Long Beach Healthcare System, Long Beach, CA

    Long Beach, Californiastudy coordinator listed

    Recruiting

  • VA Salt Lake City Health Care System, Salt Lake City, UT

    Salt Lake City, Utahstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Saurabh Chatterjee, PhD · PRINCIPAL_INVESTIGATOR · VA Long Beach Healthcare System, Long Beach, CA

Who to contact

Saurabh Chatterjee, PhD
[email protected]
(562) 826-8000
Email the study team

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Eligibility criteria

Inclusion

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

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)
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.

What this trial measures

  • Veterans Short Form 36-Item Health Survey Physical Component SummaryChange from Baseline at 3, 6, 9, 12, 18 and 20 weeks

    Veterans Health Survey contains 36 items to measure health functioning from the patient's point of view. Qualify of life will be determined per Short Form-36 for Veterans' quality of life Physical component (PCS) summary scales, range from 0 to 100 with 100 being better; 50 is expected population average.