Ignite Creation Date:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2025-12-29 @ 8:38 PM
Study NCT ID:
NCT05446168
Status:
TERMINATED
Last Update Posted:
2025-01-23
First Post:
2022-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Brain Small Chain Fatty Acid Metabolism in Parkinson Disease: Tributyrin Supplementation
Sponsor:
Nicolaas Bohnen, MD, PhD
Organization:
Study Overview
Official Title:
Brain Small Chain Fatty Acid Metabolism in Parkinson Disease: Tributyrin Supplementation
Status:
TERMINATED
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawal of funding
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BUTTER
Brief Summary:
Small exploratory open-label pilot study to assess the short-chain fatty acid (SCFA) prodrug tributyrin as a potential therapy for persons with Parkinson disease
Detailed Description:
The overarching goal of this small exploratory open-label pilot study is to explore metabolic (glucose metabolism, butyrate) and cognition (MoCa) before and after open-label treatment with the short-chain fatty acid (SCFA) prodrug tributyrin in a small pilot study in PD and normal control older adults. Positive findings in this small exploratory pilot trial may support target engagement study of SCFA supplementation in normal adults and PD.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: