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Investigation of β-hydroxybutyrate Supplementation as Chemoprevention in Familial Adenomatous Polyposis

Study acronym: BHB-FAP
StatusEnrolling by Invitation
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status changed: Recruiting → Enrolling by Invitation Eligibility criteria expanded, about 25 words · Site details revised · Publications: details revised at 1 of 1 entry Show 3 more changesShow less
    • Eligibility criteria expanded, about 25 words
    • Site details revised
    • Publications: details revised at 1 of 1 entry
  2. Interventions: R-1,3-Butanediol (10MG-A) (Dietary Supplement), R-1,3-Butanediol (20MG-A) (Dietary Supplement), R-1,3-Butanediol (30MG-A) (Dietary… to R-1,3-Butanediol (10G-A) (Dietary Supplement), R-1,3-Butanediol (20G-A) (Dietary Supplement), R-1,3-Butanediol (30G-A) (Dietary… Publications: details revised at 1 of 1 entryv4 Show 1 more changeShow less
    • Publications: details revised at 1 of 1 entry
  3. Enrollment target: 30 to 20 Interventions: Placebo (Dietary Supplement), R-1,3-Butanediol (10MG-A) (Dietary Supplement), R-1,3-Butanediol (10MG-B) (Dietary Supplement)… to R-1,3-Butanediol (10MG-A) (Dietary Supplement), R-1,3-Butanediol (20MG-A) (Dietary Supplement), R-1,3-Butanediol (30MG-A) (Dietary… · Eligibility criteria expanded, about 15 words · Study description expanded, about 18 words · 2 morev3 Show 5 more changesShow less
    • Interventions: Placebo (Dietary Supplement), R-1,3-Butanediol (10MG-A) (Dietary Supplement), R-1,3-Butanediol (10MG-B) (Dietary Supplement)… to R-1,3-Butanediol (10MG-A) (Dietary Supplement), R-1,3-Butanediol (20MG-A) (Dietary Supplement), R-1,3-Butanediol (30MG-A) (Dietary…
    • Eligibility criteria expanded, about 15 words
    • Study description expanded, about 18 words
    • Publications: details revised at 1 of 1 entry
    • Study arms: 6 to 4

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Oct 2024 to Sep 20, 2024 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Oct 2024 to Sep 20, 2024
    • Site details revised
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The aim of this study is to evaluate the potential of BHB supplementation as a novel strategy to impede the development and progression of intestinal adenomas in individuals with FAP, thus potentially reducing the need for frequent upper endoscopies and colonoscopies and preventing the need for risk-reducing surgical intervention.
Trial Details
NCT Number NCT06578637
Lead Sponsor Abramson Cancer Center at Penn Medicine
Collaborators: The V Foundation for Cancer Research
Conditions FAP, Familial Adenomatous Polyposis
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov