Parkinson DiseasePhase 1/2BUTTER2NCT07863180
Tributyrin for Progressive Supranuclear Palsy (PSP): Virtual Trial
A Phase 1/2 study testing Tributyrin in people with Parkinson Disease and Multiple System Atrophy, run by Prabesh Kanel at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Parkinson Disease, Multiple System Atrophy, Progressive Supranuclear Palsy(PSP)
- What is being tested?
- Tributyrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to May 2027
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female, age 45 years and over.
- Diagnosis of PSP-Richardson syndrome (RS) based on Movement Disorder Society (MDS) Criteria, including
- Vertical supranuclear gaze palsy.
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Domino's Farms
Ann Arbor, Michigan, 48105
Nathan Alexander, 734-998-8422, natealex@med.umich.edu
Robert Vangel, BSc, 734-936-1168, rvangel@med.umich.edu
About this study
Official title: 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.
Read the detailed description
This is a sub-study of NCT07154511.
- Being tested
- Tributyrin, Placebo
- Keywords
- short chain fatty acid, fecal microbiota transplantation, Butyric acid, Tributyrin
- Medical subject headings
- Parkinson Disease, Multiple System Atrophy, Supranuclear Palsy, Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TributyrinDrug
Post-biotic short chain fatty acid dietary supplement. Participants will take 500mg TID tributyrin supplement for 90 days +/- 7 days.
PlaceboDrug
Participants will take 500mg TID placebo for 90 days +/- 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Tributyrin | Experimental | Participants will take 500mg three times a day (TID) tributyrin supplement for 90 days +/- 7 days. Receives: Drug: Tributyrin |
| Placebo | Placebo comparator | Participants will take 500mg placebo for 90 days +/- 7 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability of tributyrin
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
Measured: Visit 7 (approximately day 90)
Safety of tributyrin
Safety will be defined as the percent of patients who experienced serious adverse events.
Measured: Up to visit 7 (approximately day 90)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prabesh Kanel
- Sponsor type
- University, hospital or other
- Collaborators
- Farmer Family Foundation
- Responsible party
- Sponsor-investigator, Prabesh Kanel, University of Michigan
- Investigators
- Prabesh Kanel, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863180
- Sponsor's protocol ID
- HUM00270219a
- Acronym
- BUTTER2
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No