Tributyrin for Parkinson's Disease
(BUTTER Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a supplement called tributyrin can help people with Parkinson's disease. Researchers aim to determine if this short-chain fatty acid might improve symptoms or brain health. The trial includes two groups: one with healthy individuals and another with people who have Parkinson's. Participants must be over 45 and either have Parkinson's or be healthy without major health issues. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I need to stop my current medications for the trial?
The trial excludes people who regularly use anti-cholinergic, benzodiazepines, or neuroleptic drugs, so you may need to stop these medications to participate. The protocol does not specify about other medications.
Is there any evidence suggesting that tributyrin is likely to be safe for humans?
Research has shown that tributyrin is generally safe to use. Past studies found it caused slight eye irritation but reported no serious long-term health effects. Tributyrin contains no dangerous materials with specific exposure limits, suggesting it is unlikely to cause significant harm under normal conditions. However, like any substance, it should be handled carefully to avoid minor irritations. Following safety guidelines, such as washing hands after use, reduces any risks.12345
Why do researchers think this study treatment might be promising for Parkinson's disease?
Unlike the standard treatments for Parkinson's disease that mainly aim to manage symptoms through dopamine replacement or modulation, tributyrin offers a fresh approach by targeting brain metabolism. Tributyrin is a small chain fatty acid that can potentially influence brain health by altering metabolic pathways, which is quite different from traditional medications like levodopa or dopamine agonists. Researchers are excited about tributyrin because it may offer neuroprotective benefits, potentially slowing disease progression rather than just addressing symptoms. This novel mechanism of action could represent a significant advancement in how we approach Parkinson's treatment.
What evidence suggests that tributyrin might be an effective treatment for Parkinson's disease?
This trial will evaluate the effects of tributyrin in two different participant groups. Research suggests that tributyrin might help alleviate symptoms of Parkinson's disease. As a type of fatty acid, tributyrin can boost brain health by raising levels of butyrate, which may protect brain cells. Studies have shown that butyrate can improve sleep and might lessen some symptoms of the disease. Additionally, tributyrin can help balance gut bacteria, which is important because gut health is connected to brain health. While these findings are promising, further research is needed to confirm its effectiveness in treating Parkinson's disease.678910
Who Is on the Research Team?
Nicolaas I Bohnen, MD, PhD
Principal Investigator
University of Michigan
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 500mg TID tributyrin supplement for 30 days +/- 7 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Tributyrin
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nicolaas Bohnen, MD, PhD
Lead Sponsor