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RECRUITING
NCT05367245
PHASE2

Ca-Mg Butyrate in GWI

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

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 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.

Official title: Microbiome Targeted Oral Butyrate Therapy in Gulf War Multisymptom Illness

Key Details

Gender

All

Age Range

40 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-01-15

Completion Date

2027-03-31

Last Updated

2025-10-31

Healthy Volunteers

No

Interventions

DRUG

Cal-Mag Butyrate

Supplements

DRUG

Placebo

Only Cal-Mag but no Butyric acid

Locations (3)

VA Long Beach Healthcare System, Long Beach, CA

Long Beach, California, United States

Miami VA Healthcare System, Miami, FL

Miami, Florida, United States

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, United States