Recruiting
Phase 2

Ca-Mg Butyrate

Sponsor:

VA Office of Research and Development

Code:

NCT05367245

Conditions

Gulf War Illness

Chronic Fatigue

Neurocognitive Dysfunction

Eligibility Criteria

Sex: All

Age: 40 - 70

Healthy Volunteers: Not accepted

Interventions

Cal-Mag Butyrate

Placebo

Study Details

Brief summary:

The primary objective of this clinical trial is to determine if treatment with Butyrate formulation that consists of butyric acid as calcium and magnesium derivatives (Ca-Mg Butyrate) improves the physical function of men and women Veterans suffering from Gulf War Illness (GWI). The primary outcome measure is a change from baseline on the Short Form Health Survey 36-item (VSF-36), with respect to physical functioning and symptoms. The secondary outcome will focus on the drug's role in (a) restoring gut microbiome and virome, (b) decreasing gastrointestinal disturbances (constipation, diarrhea, pain), (c) decreasing chronic fatigue, (d) decreasing systemic inflammation, and (e) a decrease in cognitive deficits.

Conditions

Gulf War Illness

Chronic Fatigue

Neurocognitive Dysfunction

Study ID

NCT05367245

Start date

Jan 15, 2024

Status verified date

Oct, 2025

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Oct 10, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cal-Mag-Butyrate

Take oral capsule as directed (600 mg, twice a day for 18 weeks) with or without food.

placebo comparator: Placebo for Cal-Mag-Butyrate

Take oral capsule as directed (600 mg, twice a day for 18 weeks) with or without food.

Interventions

Cal-Mag Butyrate

Supplements

Placebo

Only Cal-Mag but no Butyric acid

Primary outcome measure

  • Veterans Short Form 36-Item Health Survey Physical Component Summary [ Time Frame: Change from Baseline at 3, 6, 9, 12, 18 and 20 weeks ]

Central Contacts and Locations

Central contacts

Saurabh Chatterjee, PhD

(562) 826-8000saurabhc@hs.uci.edu

Jonathan Skupsky

(562) 826-8000Jonathan.Skupsky@va.gov

Locations

VA Long Beach Healthcare System, Long Beach, CA

Recruiting

Long Beach, California, United States, 90822

Contacts

Saurabh Chatterjee, PhD

(562) 826-8000saurabhc@hs.uci.edu

Principal Investigator:

Saurabh Chatterjee, PhD

Miami VA Healthcare System, Miami, FL

Recruiting

Miami, Florida, United States, 33125

Contacts

Nancy Klimas, MD

305-575-7000nancy.klimas@va.gov

Devra Cohen, MPH

3055757648Devra.cohen@va.gov

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

Recruiting

Salt Lake City, Utah, United States, 84148-0001

Contacts

Ashok Tuteja, MD

801-582-1565ashok.tuteja@va.gov

More Information

Sponsor

VA Office of Research and Development

Last update posted

Oct 31, 2025

Last verified

Oct, 2025

Keywords

  • SCFA
  • Gulf War Illness
  • GWI
  • Microbiome
  • Butyric acid
  • Butyrate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2025-10-31.