RecruitingPhase 2NCT05367245

Ca-Mg Butyrate in GWI

Microbiome Targeted Oral Butyrate Therapy in Gulf War Multisymptom Illness

Sponsor

VA Office of Research and Development

Enrollment

120 participants

Start Date

Jan 15, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic fatigue Neurocognitive Dysfunction Gulf War Illness

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.

Eligibility

Min Age: 40 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Cal-Mag Butyrate and a drug called Placebo for people with chronic fatigue, gulf war illness, and other related conditions. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 40 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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