drugset / Trial / NCT05367245
Ca-Mg Butyrate in GWI
Phase 2
Recruiting
120 enrolled
VA Office of Research and Development
Miami VA Healthcare System · collabVA Salt Lake City Health Care System · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2024-01-15
- Primary completion
- 2026-10-10
- Completion
- 2027-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cal-Mag Butyrate | Other / unclassified | 600 mg | Oral |