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

Recruiting now · Not applicable

Conditions studied: FAP, Familial Adenomatous Polyposis

In brief

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.

Key facts

Study ID

NCT06578637

Run by

Abramson Cancer Center at Penn Medicine

People needed

20

Starts

2024-09-20

Expected to finish

2027-10-01

Last updated by the study team

2025-09-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• History of chronic kidney disease with an eGFR \< 60 mL/min/1.73m2
• Cancer diagnosis where the subject is receiving active therapy
• Use of either a ketogenic diet or intermittent fasting (defined as a fasting period of 16 hours or more per day that is not associated with a medical procedure) during the 4 weeks prior to enrollment
• Part B
• Inclusion Criteria:
• 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.
• Willing to undergo a colonoscopy or sigmoidoscopy, which may be part of the patient's routine standard care.
• Able to have a concurrent upper endoscopy performed with the colonoscopy/sigmoidoscopy. This upper endoscopy may be part of the patient's routine standard care.
• Have at least two colorectal polyps at enrollment (which can be present anywhere in the colon including the rectal cuff, or in the J-pouch [if applicable]).
• Can provide informed consent.
• Exclusion Criteria:
• Subject is pregnant, a prisoner, or is under 18 years of age
• Patient is not able to undergo colonoscopy/sigmoidoscopy or upper endoscopy
• Prior total proctocolectomy with end ileostomy
• History of inflammatory bowel disease
• History of diabetes mellitus and are currently on medical diabetes therapy
• History of chronic kidney disease with an eGFR < 60 mL/min/1.73m2
• Cancer diagnosis where the subject is receiving active therapy
• Use of either a ketogenic diet or intermittent fasting (defined as a fasting period of 16 hours or more per day that is not associated with a medical procedure) during the 4 weeks prior to enrollment
• Regular use of any FAP-related chemopreventive agent in the 6 weeks prior to enrollment including aspirin (> 81mg daily), NSAIDs, BHB supplementation, or any other medication deemed a chemopreventive agent by the study investigators
• Any colonic or small intestinal polyp observed endoscopically that is > 1 cm in size and is not removed (excluding ampullary adenomas)

Where it is running

• Abramson Cancer Center of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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