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SCFA Prodrug

tributyrin for Parkinson's Disease (BUTTER Trial)

Phase 1
Waitlist Available
Led By Nicolaas I Bohnen, MD, PhD
Research Sponsored by Nicolaas Bohnen, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after approximately 30 days of intervention
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing tributyrin, a substance that turns into a helpful fatty acid in the body. It aims to see if it can improve brain function and metabolism in people with Parkinson's disease and normal older adults. If successful, it could lead to further studies on using this fatty acid for health benefits. Sodium butyrate, a similar compound to tributyrin, has shown potential in improving motor and cognitive deficits in Parkinson's disease models.

Eligible Conditions
  • Parkinson's Disease
  • Overactive Bladder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after approximately 30 days of intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and after approximately 30 days of intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
glucose metabolism
Secondary study objectives
FDG glucose PET brain
Montreal Cognitive Assessment cognitive rating scale (MoCa)
Brain

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Parkinson's Disease Tributyrin InterventionExperimental Treatment1 Intervention
Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.
Group II: Healthy Control Tributyrin InterventionExperimental Treatment1 Intervention
Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tributyrin
Not yet FDA approved

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Nicolaas Bohnen, MD, PhDLead Sponsor
1 Previous Clinical Trials
34 Total Patients Enrolled
Nicolaas I Bohnen, MD, PhDPrincipal InvestigatorUniversity of Michigan
2 Previous Clinical Trials
70 Total Patients Enrolled

Media Library

Tributyrin (SCFA Prodrug) Clinical Trial Eligibility Overview. Trial Name: NCT05446168 — Phase 1
Parkinson's Disease Research Study Groups: Healthy Control Tributyrin Intervention, Parkinson's Disease Tributyrin Intervention
Parkinson's Disease Clinical Trial 2023: Tributyrin Highlights & Side Effects. Trial Name: NCT05446168 — Phase 1
Tributyrin (SCFA Prodrug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05446168 — Phase 1
Parkinson's Disease Patient Testimony for trial: Trial Name: NCT05446168 — Phase 1
~5 spots leftby Nov 2025