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NCT05367245 · ClinicalTrials.gov registry record · Phase 2

Ca-Mg Butyrate in GWI

A Phase 2 study of Gulf War Illness and Neurocognitive Dysfunction, sponsored by VA Office of Research and Development.

Recruiting
Registry status
Phase 2
Development phase
120
Enrollment target
3
Study locations

NCT05367245: Recruiting Phase 2 study of Gulf War Illness and Neurocognitive Dysfunction, sponsored by VA Office of Research and Development.

NCT05367245 is a Phase 2 study of Gulf War Illness and Neurocognitive Dysfunction that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 120 participants, roughly in line with the 121-participant average among 14 other Gulf War Illness trials with a reported enrollment target. The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05367245, a Phase 2 study of Gulf War Illness and Neurocognitive Dysfunction, is actively recruiting participants, sponsored by VA Office of Research and Development.

RECRUITING
Registry status
Phase 2
Development phase
120 participants
Enrollment target
3
Study locations

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.

Primary Outcome

Veterans Health Survey contains 36 items to measure health functioning from the patient's point of view. Qualify of life will be determined per Short Form-36 for Veterans' quality of life Physical component (PCS) summary scales, range from 0 to 100 with 100 being better; 50 is expected population average.

Conditions Studied

Gulf War Illness Neurocognitive Dysfunction Chronic Fatigue

Interventions

  • DRUG Placebo
  • DRUG Cal-Mag Butyrate

Study Locations (3)

California

  • VA Long Beach Healthcare System, Long Beach, CA - Long Beach

Florida

  • Miami VA Healthcare System, Miami, FL - Miami

Utah

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

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2024-01-15
Est. Completion 2027-03-31
Phase Phase 2
VA Office of Research and Development

1,668 total trials

What NCT05367245 shows while recruiting

NCT05367245 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 121-participant average among 14 other Gulf War Illness trials with a reported enrollment target.

The record links to 3 conditions, with Gulf War Illness appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05367245 reports a single indexed study location in California, Florida, Utah.

Frequently Asked Questions

What is clinical trial NCT05367245 about?

NCT05367245 is a clinical study titled "Ca-Mg Butyrate in GWI". 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 ...

What is the current status of trial NCT05367245?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2024-01-15. Estimated completion is 2027-03-31.

What conditions does trial NCT05367245 study?

This clinical trial studies the following conditions: Gulf War Illness, Neurocognitive Dysfunction, Chronic Fatigue.

What interventions are being tested in trial NCT05367245?

The interventions under investigation include: Placebo (DRUG), Cal-Mag Butyrate (DRUG).

Who is sponsoring clinical trial NCT05367245?

This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05367245 being conducted?

This trial has 3 study locations across California, Florida, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Gulf War Illness

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05367245's enrollment target sits among peer trials

120 5th of 14 higher than 10 of 14 other Gulf War Illness trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Gulf War Illness trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT05367245

Source: ClinicalTrials.gov NCT05367245, the US trial registry maintained by the National Library of Medicine. NCT05367245 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.