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Ca-Mg Butyrate in GWI

NCT05367245 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-10-31

No results posted yet for this study

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.

Conditions

  • Gulf War Illness
  • Chronic Fatigue
  • Neurocognitive Dysfunction

Interventions

DRUG

Cal-Mag Butyrate

Supplements

DRUG

Placebo

Only Cal-Mag but no Butyric acid

Sponsors & Collaborators

  • Miami VA Healthcare System

    collaborator FED

  • VA Salt Lake City Health Care System

    collaborator FED

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Saurabh Chatterjee, PhD · VA Long Beach Healthcare System, Long Beach, CA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-15
Primary Completion
2026-10-10
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05367245 on ClinicalTrials.gov