Your session is about to expire
← Back to Search
Short Chain Fatty Acid
Ca-Mg Butyrate for Gulf War Syndrome (Butyrate Trial)
Phase 2
Recruiting
Led By Saurabh Chatterjee, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Defined rheumatologic inflammatory disorders
Immunosuppressive drugs or biologic response modifiers within 3 months of study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at 3, 6, 9, 12, 18 and 20 weeks
Summary
This trial is looking to see if a treatment consisting of butyric acid calcium and magnesium derivatives (Ca-Mg Butyrate) can improve the physical function of Veterans suffering from Gulf War Illness (GWI), as measured by the Short Form Health Survey 36-item (VSF-36). The trial will also focus on the drug's role in restoring gut microbiome and virome, decreasing gastrointestinal disturbances, chronic fatigue, systemic inflammation, and cognitive deficits.
Who is the study for?
This trial is for Gulf War era veterans aged between 40 and 70 who suffer from moderate to severe GWI, as defined by CDC and Kansas criteria. Participants must score less than 30 on the VSF36 physical domain, with no other health conditions that could explain their symptoms.
What is being tested?
The trial tests if Ca-Mg Butyrate improves physical function in those with GWI. It measures changes in physical functioning via the VSF-36 survey and examines effects on gut microbiome, gastrointestinal issues, chronic fatigue, inflammation, and cognitive deficits.
What are the potential side effects?
Potential side effects are not explicitly listed but may include digestive disturbances or allergic reactions related to butyrate supplements or their derivatives.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a diagnosed inflammatory disorder.
Select...
I haven't taken immunosuppressive drugs or biologics in the last 3 months.
Select...
I have bipolar disorder and have not received treatment for it.
Select...
My organs are functioning properly.
Select...
I have had an organ transplant.
Select...
I haven't taken medications affecting my gut, pain, or immune system in the last 3 months.
Select...
I have schizophrenia that has not been treated.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline at 3, 6, 9, 12, 18 and 20 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at 3, 6, 9, 12, 18 and 20 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Veterans Short Form 36-Item Health Survey Physical Component Summary
Secondary study objectives
California Verbal Learning Test (CVLT-II)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cal-Mag-ButyrateExperimental Treatment1 Intervention
Take oral capsule as directed (600 mg, twice a day for 18 weeks) with or without food.
Group II: Placebo for Cal-Mag-ButyratePlacebo Group1 Intervention
Take oral capsule as directed (600 mg, twice a day for 18 weeks) with or without food.
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,663 Total Patients Enrolled
Miami VA Healthcare SystemFED
17 Previous Clinical Trials
2,287 Total Patients Enrolled
VA Salt Lake City Health Care SystemFED
24 Previous Clinical Trials
261,943 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a diagnosed inflammatory disorder.I am taking supplements for gut health or immune support.I have celiac disease, late-stage liver cirrhosis, or recent gastrointestinal changes due to medication or infection.I haven't taken calcium or magnesium butyrate supplements for 3 months.I have a severe fatigue illness that can't be explained by other diagnoses.I haven't taken immunosuppressive drugs or biologics in the last 3 months.I have bipolar disorder and have not received treatment for it.My organs are functioning properly.I have had an organ transplant.I haven't taken medications affecting my gut, pain, or immune system in the last 3 months.I haven't taken drugs for GI movement or antibiotics in the last 2 months.I have schizophrenia that has not been treated.I haven't used Butyrate in any form in the last 3 months.I am a Gulf War veteran aged 40-70, in good health before 1990, with symptoms fitting GWI without other explanations.I haven't taken steroids, antibiotics, or immunosuppressives in the last month.I am a Gulf War veteran between 40 and 70, healthy before 1990, and meet the GWI criteria.
Research Study Groups:
This trial has the following groups:- Group 1: Cal-Mag-Butyrate
- Group 2: Placebo for Cal-Mag-Butyrate
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Learn More About These Treatments
Share this study with friends
Copy Link
Messenger