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NCT06578637 · ClinicalTrials.gov registry record · NA
Investigation of β-hydroxybutyrate Supplementation as Chemoprevention in Familial Adenomatous Polyposis
A NA study of Familial Adenomatous Polyposis and FAP, sponsored by Abramson Cancer Center at Penn Medicine.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06578637: Recruiting NA study of Familial Adenomatous Polyposis and FAP, sponsored by Abramson Cancer Center at Penn Medicine.
NCT06578637 is a NA study of Familial Adenomatous Polyposis and FAP that is actively recruiting participants, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 20 participants, below the 247-participant average among 10 other Familial Adenomatous Polyposis trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06578637, a NA study of Familial Adenomatous Polyposis and FAP, is actively recruiting participants, sponsored by Abramson Cancer Center at Penn Medicine.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Assessment of FAP patient tolerance of BHB supplements through monitoring of side effects and/or intolerances and patient compliance. We will monitor the percentage of individuals who continue BHB supplementation for the duration of the study, as well as the compliance with taking the BHB supplement.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT R-1,3-Butanediol (10G-A)
- DIETARY_SUPPLEMENT R-1,3-Butanediol (20G-A)
- DIETARY_SUPPLEMENT R-1,3-Butanediol (30G-A)
- DIETARY_SUPPLEMENT R-1,3-Butanediol (30G-B)
Study Locations (1)
Pennsylvania
- Abramson Cancer Center of the University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-09-20 |
| Est. Completion | 2027-10 |
| Phase | NA |
What NCT06578637 shows while recruiting
NCT06578637 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 247-participant average among 10 other Familial Adenomatous Polyposis trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Familial Adenomatous Polyposis appearing as the primary indexed condition, and to 4 interventions - of which R-1,3-Butanediol (10G-A) is the first listed.
NCT06578637 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06578637 about?
NCT06578637 is a clinical study titled "Investigation of β-hydroxybutyrate Supplementation as Chemoprevention in Familial Adenomatous Polyposis". 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...
What is the current status of trial NCT06578637?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2024-09-20. Estimated completion is 2027-10.
What conditions does trial NCT06578637 study?
This clinical trial studies the following conditions: Familial Adenomatous Polyposis, FAP.
What interventions are being tested in trial NCT06578637?
The interventions under investigation include: R-1,3-Butanediol (10G-A) (DIETARY_SUPPLEMENT), R-1,3-Butanediol (20G-A) (DIETARY_SUPPLEMENT), R-1,3-Butanediol (30G-A) (DIETARY_SUPPLEMENT), R-1,3-Butanediol (30G-B) (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT06578637?
This trial is sponsored by Abramson Cancer Center at Penn Medicine, which has 402 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06578637 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06578637's enrollment target sits among peer trials
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