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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tributyrin for PSP: Phase 1b Virtual Trial - Feasibility Study
- ClinicalTrials.gov ID
- NCT07863180
- Acronym / sponsor ID
- BUTTER2 / HUM00270219a
- Keywords
- short chain fatty acid, fecal microbiota transplantation, Butyric acid, Tributyrin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Prabesh KanelUniversity, hospital or other
- Collaborators
- Farmer Family Foundation
- Study start
- Sep 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a sub-study of NCT07154511.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tributyrin | Experimental | Drug: TributyrinParticipants will take 500mg three times a day (TID) tributyrin supplement for 90 days +/- 7 days. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will take 500mg placebo for 90 days +/- 7 days. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or Female, age 45 years and over.
- Diagnosis of PSP-Richardson syndrome (RS) based on Movement Disorder Society (MDS) Criteria, including
- Access to the internet and webcam for virtual visits.
- Presence of a caregiver.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TributyrinPost-biotic short chain fatty acid dietary supplement. Participants will take 500mg TID tributyrin supplement for 90 days +/- 7 days. | Drug | Tributyrin |
| PlaceboParticipants will take 500mg TID placebo for 90 days +/- 7 days. | Drug | Placebo |
Primary outcome
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prabesh Kanel, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nathan Alexander (734-998-8422, natealex@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability of tributyrin (time frame: Visit 7 (approximately day 90)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.