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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at 3, 6, 9, 12, 18 and 20 weeks
Awards & highlights

Butyrate Trial 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.Check my eligibility
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.See study design
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.

Butyrate Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at 3, 6, 9, 12, 18 and 20 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at 3, 6, 9, 12, 18 and 20 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Veterans Short Form 36-Item Health Survey Physical Component Summary
Secondary outcome measures
California Verbal Learning Test (CVLT-II)

Butyrate 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
1,611 Previous Clinical Trials
3,305,164 Total Patients Enrolled
1 Trials studying Gulf War Syndrome
128 Patients Enrolled for Gulf War Syndrome
Miami VA Healthcare SystemFED
17 Previous Clinical Trials
2,281 Total Patients Enrolled
1 Trials studying Gulf War Syndrome
170 Patients Enrolled for Gulf War Syndrome
VA Salt Lake City Health Care SystemFED
24 Previous Clinical Trials
264,811 Total Patients Enrolled

Media Library

Ca-Mg Butyrate (Short Chain Fatty Acid) Clinical Trial Eligibility Overview. Trial Name: NCT05367245 — Phase 2
Gulf War Syndrome Research Study Groups: Cal-Mag-Butyrate, Placebo for Cal-Mag-Butyrate
Gulf War Syndrome Clinical Trial 2023: Ca-Mg Butyrate Highlights & Side Effects. Trial Name: NCT05367245 — Phase 2
Ca-Mg Butyrate (Short Chain Fatty Acid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05367245 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I join this clinical trial, based on my current health status?

"To qualify for this study, potential patients must be veterans of the Gulf War era, between the ages of 40 and 70. They must also be in good health, with no pre-existing conditions that could explain their fatigue. Furthermore, the severity of their illness must be moderate to severe."

Answered by AI

Does the age limit for this research study exclude adults over 65 years old?

"In order to be eligible for this clinical trial, applicants must be aged between 40 and 70. Out of the 581 total trials, this is one of the 26 trials catering to a younger demographic and 555 trials for patients over the age of 65."

Answered by AI

What are the documented side effects of Cal-Mag Butyrate?

"Cal-Mag Butyrate is in Phase 2 of clinical trials, meaning that while there is some evidence supporting its safety, there is no data yet to suggest that it is an effective medication."

Answered by AI

Who else is applying?

What state do they live in?
South Carolina
How old are they?
65+
What site did they apply to?
Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Most responsive sites:
  1. Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC: < 48 hours
Typically responds via
Email
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Ca-Mg Butyrate in GWI
2024. "Ca-Mg Butyrate in GWI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05367245.
All > Me Cfs > Chronic Fatigue Syndrome
~80 spots leftby Jan 2025
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