15 Participants NeededMy employer runs this trial

Tributyrin for Progressive Supranuclear Palsy

(BUTTER2 Trial)

NA
RV
Overseen ByRobert Vangel, BSc

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a supplement called tributyrin to determine its safety and tolerability for people with Progressive Supranuclear Palsy (PSP), a brain disease affecting balance, movement, and eye movement. Researchers aim to discover if taking this supplement and participating in virtual check-ups benefits those with PSP. Participants will take either the tributyrin supplement or a placebo (a harmless pill with no active ingredient) for about three months. The trial seeks individuals diagnosed with PSP-Richardson syndrome who have trouble with eye movement and frequently experience unprovoked falls. Participants must have internet access for virtual visits and a caregiver to assist them. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking PSP research.

Is there any evidence suggesting that tributyrin is likely to be safe for humans?

Research has shown that tributyrin appears safe when tested in people. In a small study for Parkinson's disease, participants tolerated tributyrin well, with no major safety issues. This study was the first to provide data on humans and suggested that tributyrin could be safe to use. Although specific safety studies for Progressive Supranuclear Palsy (PSP) are lacking, the positive results in other conditions are promising. Always consult a healthcare professional to understand the possible risks and benefits.12345

Why do researchers think this study treatment might be promising for PSP?

Unlike the standard treatments for Progressive Supranuclear Palsy, which typically focus on managing symptoms with medications like levodopa, Tributyrin is unique because it targets the condition at a cellular level. Researchers are excited about Tributyrin because it is a derivative of butyrate, a substance thought to have neuroprotective properties that might help slow disease progression. This potential new mechanism of action sets it apart from current therapies that do not alter the underlying disease process.

What evidence suggests that tributyrin might be an effective treatment for Progressive Supranuclear Palsy?

Research suggests that tributyrin might help individuals with Progressive Supranuclear Palsy (PSP). Tributyrin, a form of butyrate, is a fatty acid that may enhance brain health. Some studies have indicated that butyrate can reduce inflammation and protect brain cells, potentially benefiting those with PSP. Although direct evidence on tributyrin specifically for PSP remains limited, its positive effects on brain health warrant further investigation. In this trial, participants will receive either tributyrin or a placebo to assess its effectiveness. Early signs suggest tributyrin might help manage symptoms, but further research is necessary to confirm its efficacy.678910

Who Is on the Research Team?

PK

Prabesh Kanel, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with Progressive Supranuclear Palsy (PSP). Participants should be able to take part in virtual study visits and follow the supplement regimen. People with other serious health issues or who can't safely participate may not be eligible.

Inclusion Criteria

I am 45 years old or older.
Access to the internet and webcam for virtual visits
Presence of a caregiver
See 2 more

Exclusion Criteria

Significant metabolic or uncontrolled medical comorbidity
I am a woman who could become pregnant, is pregnant, or is currently breastfeeding.
Any other condition or criterion that, in the opinion of the investigators, would preclude safe and meaningful participation in the study
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 500mg tributyrin or placebo three times a day for 90 days

13 weeks
7 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Tributyrin

Trial Overview

The study is testing a supplement called tributyrin compared to a placebo (inactive substance) in people with PSP. The main focus is on safety, tolerability, and whether this kind of virtual trial can work well.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: TributyrinExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Prabesh Kanel

Lead Sponsor

Farmer Family Foundation

Collaborator

Trials
1
Recruited
20+

Citations

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7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41271518/

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