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New treatment option for Gulf War Illness
Official title Ca-Mg Butyrate in GWI
ClinicalTrials.gov ID: NCT05367245
What this study is testing
What is Cal-Mag Butyrate?
Cal-Mag Butyrate is an investigational medicine, given as a twice-daily pill taken by mouth, being studied as a potential treatment for gulf war illness.
Also referred to as Bodybio Calcium Magnesium Butyrate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 70
You may be able to join if
- 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...
- currently have no exclusionary diagnoses (self- reported) that could reasonably explain the symptoms of their fatiguing illness. The severity of...
You likely can't join if
- 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.
See the full eligibility 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Long Beach, California, United States
- Miami, Florida, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Long Beach, California, United States; Miami, Florida, United States; Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.