Investigation of β-hydroxybutyrate Supplementation as Chemoprevention in Familial Adenomatous Polyposis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbramson Cancer Center at Penn Medicine
About this trial
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.
Eligibility criteria
Qualifiers
Have a diagnosis of FAP with genetic testing demonstrating a pathogenic or likely pathogenic germline variant in APC, must have a clinical FAP phenotype with at least one member of the family who has a pathogenic or likely pathogenic germline variant in APC, or must have a clinical diagnosis of FAP as agreed by two gastrointestinal cancer genetics experts
Must have an extensive colonic resection with either a subtotal colectomy with ileorectal anastomosis (STC-IRA) or total proctocolectomy with ileal pouch anal anastomosis (TPC-IPAA)
Can provide informed consent
Disqualifiers
Subject is pregnant, a prisoner, or is under 18 years of age
Prior total proctocolectomy with end ileostomy
History of inflammatory bowel disease
History of diabetes mellitus and are currently on medical diabetes therapy
Trial design
Treatments tested in this trial
- R-1,3-Butanediol (10G-A)
- R-1,3-Butanediol (20G-A)
- R-1,3-Butanediol (30G-A)
- R-1,3-Butanediol (30G-B)
Treatment groups
20 Participants
are divided into 4 treatment groupsSponsors and collaborators
Abramson Cancer Center at Penn Medicine
Lead sponsor
The V Foundation for Cancer Research
Collaborator
Source ClinicalTrials.gov