drugset / Trial / NCT05367245

Ca-Mg Butyrate in GWI

NCT05367245 ↗

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

EvaluationDrugModalityDoseRoute
Subject Cal-Mag Butyrate Other / unclassified 600 mg Oral