Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06351124
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-03-26
Brief Title:
Beta-Hydroxybutyrate Feasibility Treating IBD
Sponsor:
University of Texas at Austin
Organization:
University of Texas at Austin
Study Overview
Official Title:
Feasibility of Beta-hydroxybutyrate Supplementation to Reduce Inflammation in Patients with Inflammatory Bowel Disease
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BHB
Brief Summary:
This clinical trial aims to understand the feasibility of patients taking ketone body supplement beta-hydroxybutyrate BHB for 4 weeks with a confirmed diagnosis of Crohns disease and starting new therapy for active disease
The main questions it aims to answer are
BHB supplementation will be feasible and acceptable to patients
BHB supplementation will be associated with a reduction in systemic inflammation
BHB supplementation will be associated with a reduction in pro-inflammatory bacterial colonies
Participants will
Take 3 capsules x 3 times per day for 4 weeks
Document food consumption using a 24-hour food recall questionnaire
Provide blood and fecal samples twice at the beginning of the study and the 4-week mark
Researchers will compare the group taking the ketone body supplement and the group not taking the supplement to see if the supplement provides relief of symptoms suffered from Crohns disease
The main questions it aims to answer are
BHB supplementation will be feasible and acceptable to patients
BHB supplementation will be associated with a reduction in systemic inflammation
BHB supplementation will be associated with a reduction in pro-inflammatory bacterial colonies
Participants will
Take 3 capsules x 3 times per day for 4 weeks
Document food consumption using a 24-hour food recall questionnaire
Provide blood and fecal samples twice at the beginning of the study and the 4-week mark
Researchers will compare the group taking the ketone body supplement and the group not taking the supplement to see if the supplement provides relief of symptoms suffered from Crohns disease
Detailed Description:
A clinical trial designed to determine the feasibility of prebiotic supplementation with beta-hydroxybutyrate BHB in Crohns patients in a prospective open-label pilot trial and to assess the association between BHB supplementation and changes in the microbiome inflammation and markers of disease severity in Crohns patients in a prospective pre-post-study design
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None