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Beta-Hydroxybutyrate Feasibility Treating IBD

Study acronym: BHB
StatusUnknown
PhasePhase 1/2
Started
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Record status
This record was last updated September 19, 2024 (before its estimated April 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Secondary endpoints revised (8)v7
  3. Enrollment target: 12 to 20
    • Start date changed from estimate of May 15, 2024 to Aug 28, 2024
    • Secondary endpoints: 7 to 8
    v6
  4. Interventions: Feasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Inflammatory Bowel Disease (Biological) to Feasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Crohn's (Biological)
    • Study title revised
    v5
  5. Secondary endpoints: details revised at 1 of 7 entriesv4
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  1. Secondary endpoints revised (7)v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Apr 1, 2024 to May 15, 2024
    • Secondary endpoints revised (7)
    • Site details revised
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
This clinical trial aims to understand the feasibility of patients taking ketone body supplement beta-hydroxybutyrate (BHB) for 4 weeks with a confirmed diagnosis of Crohn's disease and starting new therapy for active disease. The main questions it aims to answer are: * BHB supplementation will be feasible and acceptable to patients. * BHB supplementation will be associated with a reduction in systemic inflammation. * BHB supplementation will be associated with a reduction in pro-inflammatory bacterial colonies. Participants will: * Take 3 capsules x 3 times per day for 4 weeks. * Document food consumption using a 24-hour food recall questionnaire. * Provide blood and fecal samples twice, at the beginning of the study and the 4-week mark. Researchers will compare the group taking the ketone body supplement and the group not taking the supplement to see if the supplement provides relief of symptoms suffered from Crohn's disease.
Trial Details
NCT Number NCT06351124
Lead Sponsor University of Texas at Austin
Conditions
(from sponsor)		 Crohn's Disease, Inflammatory Bowel Diseases
Related terms Crohn Disease, Inflammation, Inflammatory Bowel Diseases
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov