Actively Recruiting
Ca-Mg Butyrate in GWI
Led by VA Office of Research and Development · Updated on 2025-10-31
120
Participants Needed
3
Research Sites
167 weeks
Total Duration
On this page
Sponsors
V
VA Office of Research and Development
Lead Sponsor
M
Miami VA Healthcare System
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Ca-Mg Butyrate in GWI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Gulf War era veteran deployed and between 40 and 70 years old
- Good health before 1990 based on medical history
- Meet Gulf War Illness case definitions of CDC and Kansas criteria
- No exclusionary diagnoses explaining fatiguing illness symptoms
- Moderate to severe illness with a physical function score below 30 on the Veterans Short Form 36
You will not qualify if you...
- Untreated schizophrenia, bipolar disorder, delusional disorders, or dementias
- Active alcoholism or drug abuse
- Organ failure, defined rheumatologic inflammatory disorders, or organ transplant
- Use of butyrate supplements within 3 months before the study
- Use of medications affecting gut motility, diarrhea, chronic pain, or immune function in last 1-3 months
- Use of immunosuppressive drugs or biologic response modifiers within 3 months
- Pregnancy or planning pregnancy within 6 months
- Body mass index over 35
- Special diets enriched with fiber or butyrogenic formulations
- Allergy to butyrate supplements or related ingredients
- Evidence of celiac disease, late-stage liver cirrhosis, Giardia antigen, or Clostridium difficile toxin
- Recent changes in gastrointestinal medications
- Use of antibiotics in the last 2 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, United States, 90822
Actively Recruiting
2
Miami VA Healthcare System, Miami, FL
Miami, Florida, United States, 33125
Actively Recruiting
3
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, United States, 84148-0001
Actively Recruiting
Research Team
S
Saurabh Chatterjee, PhD
CONTACT
J
Jonathan Skupsky
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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