Status:
RECRUITING
Ca-Mg Butyrate in GWI
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
Miami VA Healthcare System
VA Salt Lake City Health Care System
Conditions:
Gulf War Illness
Chronic Fatigue
Eligibility:
All Genders
40-70 years
Phase:
PHASE2
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 phy...
Detailed Description
Nearly one third of 700,000 military personnel deployed during Desert Shield and Desert Storm (Aug 2, 1990 to July 31, 1991) in the Kuwaiti War Theater are suffering from Gulf War Illness (GWI), an un...
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)
- 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.
Key Trial Info
Start Date :
January 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05367245
Start Date
January 15 2024
End Date
March 31 2027
Last Update
October 31 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, United States, 90822
2
Miami VA Healthcare System, Miami, FL
Miami, Florida, United States, 33125
3
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, United States, 84148-0001