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Recruiting NCT06578637

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

Trial Parameters

Condition FAP
Sponsor Abramson Cancer Center at Penn Medicine
Study Type INTERVENTIONAL
Phase N/A
Enrollment 20
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-09-20
Completion 2027-10
Interventions
R-1,3-Butanediol (10G-A)R-1,3-Butanediol (20G-A)R-1,3-Butanediol (30G-A)

Brief Summary

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

Part A Inclusion Criteria: 1. 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 2. 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) 3. Can provide informed consent Exclusion Criteria: 1. Subject is pregnant, a prisoner, or is under 18 years of age 2. Prior total proctocolectomy with end ileostomy 3. History of inflammatory bowel disease 4. History of diabetes mellitus and are currently on medical diabetes therapy 5. History of chronic kidney disease with an eGFR \< 60 mL/min/1.73m2 6. Cancer diagnosis where the subject is receiving active therapy 7.

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