Ca-Mg Butyrate in Gulf War Illness

Study acronym: Butyrate
StatusRecruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 2 months later Oct 10, 2026 → Dec 31, 2027
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Record History

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  1. Primary completion pushed from Oct 10, 2026 to Dec 31, 2027 Show 5 more changesShow less
    • Study completion pushed from Mar 31, 2027 to Dec 31, 2028
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site contacts updated at 1 of 3 sites
    • Study title expanded, about 2 words
  2. Site contacts updated at 3 of 3 sitesv12
  3. Primary completion date: Oct 10, 2025 to Oct 10, 2026
    • Study completion date: Mar 31, 2026 to Mar 31, 2027
    v11
  4. Primary completion date: Jan 10, 2025 to Oct 10, 2025
    • Site details revised at 2 of 3 sites
    v10
  5. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 3 of 3 sites
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Start date: Jan 1, 2024 to Jan 15, 2024v8
  2. Re-verified, no change to tracked fieldsv7
  3. Start date: Dec 1, 2023 to Jan 1, 2024v6
  4. Start date: Nov 1, 2023 to Dec 1, 2023v5
  5. Start date: Sep 1, 2023 to Nov 1, 2023v4
  6. Start date: Mar 1, 2023 to Sep 1, 2023
    • Study sites revised (3)
    v3
  7. Start date: Sep 1, 2022 to Mar 1, 2023v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05367245
Lead Sponsor VA Office of Research and Development
Collaborators: Miami VA Healthcare System, VA Salt Lake City Health Care System
Conditions
(from sponsor)		 Gulf War Illness, Chronic Fatigue, Neurocognitive Dysfunction
Related terms Cognition Disorders
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov