RECRUITING

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

Conditions

FAP Familial Adenomatous Polyposis Chemoprevention Polyps BHB Beta-hydroxybutyrate

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2024-09-20

Study Completion:2027-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06578637

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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. 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

Inclusion Criteria

Exclusion 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

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. 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

Contacts and Locations

Study Contact

Bryson W Katona, MD, PhD

CONTACT

215-349-8222

bryson.katona@pennmedicine.upenn.edu

Principal Investigator

Bryson W Katona, MD, PhD

PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Study Locations (Sites)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: Abramson Cancer Center at Penn Medicine

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-20

Study Completion Date2027-10

Study Record Updates

Study Start Date2024-09-20

Study Completion Date2027-10

Terms related to this study

Keywords Provided by Researchers

FAP
Familial adenomatous polyposis
Chemoprevention
Polyps
BHB
Beta-hydroxybutyrate

Additional Relevant MeSH Terms

FAP
Familial Adenomatous Polyposis