Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06578637
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Investigation of β-hydroxybutyrate Supplementation as Chemoprevention in Familial Adenomatous Polyposis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Investigation of β-hydroxybutyrate Supplementation as Chemoprevention in Familial Adenomatous Polyposis
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BHB-FAP
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 reducing the need for frequent upper endoscopies and colonoscopies and potentially preventing the need for risk-reducing surgical intervention
Detailed Description:
We plan to undertake both an initial absorption study Part A in up to 9 individuals with FAP followed by a longitudinal randomized placebo-controlled study Part B in 30 individuals with FAP who will receive R-13-butanediol HVMN Ketone-IQ an orally administered BHB precursor Participants with FAP in Part A will have a blood sample collected and then take R-13-butanediol at one of three different doses for 2 weeks which will be followed by another blood sample collection In Part B participants with FAP who undergo their scheduled colonoscopysigmoidoscopy along with an upper endoscopy will be consented and subsequently randomized to receive either placebo 10 individuals or R-13-butanediol at one of two doses 20 individuals The participants then return every 4 weeks for a blood draw and at that time will also provide a stool sample which will allow us to monitor the levels of BHB in their systemic circulation and stool After 12 weeks of R-13-butanediol consumption an upper endoscopy and colonoscopysigmoidoscopy will be performed which will be the same as the procedure performed on study entry
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None