Tributyrin for Progressive Supranuclear Palsy (PSP): Virtual Trial (BUTTER2)

November 3, 2026 updated by: Prabesh Kanel

Tributyrin for PSP: Phase 1b Virtual Trial - Feasibility Study

This research is studying a supplement called tributyrin in people with Progressive Supranuclear Palsy (PSP) to learn about its safety and tolerability as a potential treatment. The goal of this research study is to see if a similar supplementation regimen and virtual testing is feasible for people with PSP.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a sub-study of NCT07154511.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Recruiting
        • Domino's Farms
        • Contact:
        • Principal Investigator:
          • Prabesh Kanel, PhD
        • Sub-Investigator:
          • Nicolaas Bohnen, MD, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or Female, age 45 years and over.

  • Diagnosis of PSP-Richardson syndrome (RS) based on Movement Disorder Society (MDS) Criteria, including

    1. Vertical supranuclear gaze palsy.
    2. Repeated unprovoked falls OR tendency to fall on the pull test within 3 years.

  • Access to the internet and webcam for virtual visits.

  • Presence of a caregiver.

Exclusion Criteria:

  • Recent history of significant, uncontrolled GI disease such as Gastroesophageal reflux disease, colorectal cancer.
  • Significant metabolic or uncontrolled medical comorbidity.
  • Regular use of typical anti-cholinergic drugs.
  • Women of child-bearing potential, or who are pregnant and/or nursing.
  • Suicidal ideation, as indicated by a response of 2 or 3 on question 9 of the Beck Depression Inventory.
  • Any other condition or criterion that, in the opinion of the investigators, would preclude safe and meaningful participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tributyrin

Participants will take 500mg three times a day (TID) tributyrin supplement for 90 days +/- 7 days.
Drug: Tributyrin

Post-biotic short chain fatty acid dietary supplement. Participants will take 500mg TID tributyrin supplement for 90 days +/- 7 days.
Placebo Comparator: Placebo

Participants will take 500mg placebo for 90 days +/- 7 days.
Drug: Placebo

Participants will take 500mg TID placebo for 90 days +/- 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerability of tributyrin
Time Frame: Visit 7 (approximately day 90)

Tolerability will be defined as the percent of patients that dropped out of the study. (# enrolled at baseline-# enrolled on visit 7)/# enrolled at baseline
Visit 7 (approximately day 90)
Safety of tributyrin
Time Frame: Up to visit 7 (approximately day 90)

Safety will be defined as the percent of patients who experienced serious adverse events.
Up to visit 7 (approximately day 90)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prabesh Kanel

Collaborators

Farmer Family Foundation

Investigators

  • Principal Investigator: Prabesh Kanel, PhD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

October 1, 2026

First Submitted That Met QC Criteria

October 1, 2026

First Posted (Actual)

October 7, 2026

Study Record Updates

Last Update Posted (Actual)

November 5, 2026

Last Update Submitted That Met QC Criteria

November 3, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00270219a

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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