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

Description

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 reducing the need for frequent upper endoscopies and colonoscopies, and potentially preventing the need for risk-reducing surgical intervention.

Conditions

FAP, Familial Adenomatous Polyposis

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Study Overview

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Study Details

Study overview

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 reducing the need for frequent upper endoscopies and colonoscopies, and potentially preventing the need for risk-reducing surgical intervention.

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

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

Condition
FAP
Intervention / Treatment

-

Contacts and Locations

Philadelphia

Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Abramson Cancer Center at Penn Medicine,

Bryson W Katona, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

2027-10