Recruiting

Phase 1

Phase 2

TributyrinPhase 2 Trial of Tributyrin in People With Parkinson's Disease and Cognitive Impairments

Sponsor:

Prabesh Kanel

Code:

NCT07154511

Conditions

Parkinson Disease

Parkinson Disease Dementia

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Interventions

Tributyrin

Placebo

Study Details

Brief summary:

The goal of this clinical trial is to learn if taking a tributyrin supplement works to improve memory and thinking and walking and balance in adults with Parkinson disease Parkinson disease dementia. It will also learn about the safety of tributyrin supplementation. The main questions it aims to answer are:

1. Does tributyrin improve memory/thinking test scores and walking/balance ability?
2. What medical problems do participants have when taking tributyrin?

Researchers will compare tributyrin to a placebo (a look-alike substance that contains no drug) to see if tributyrin works to treat Parkinson disease symptoms.

Participants will:

1. Take tributyrin 3 times a day for 80-100 days
2. Complete motor and cognitive testing at the clinic before and after the supplementation period
3. Complete brain imaging (MRI scans and PET scans) before and after the supplementation period.

Conditions

Parkinson Disease

Parkinson Disease Dementia

Study ID

NCT07154511

Start date

Nov 7, 2025

Status verified date

Nov, 2025

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Male or Female, age 45 years and over.
Diagnosis of PD based on the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Research Criteria (Hughes et al., 1992) AND evidence of mild cognitive impairment (Litvan et al., 2012) OR Diagnosis of PDD (Emre et al., 2007).
If taking cholinesterase inhibitors, benzodiazepines, memantine, or anti-psychotic medications, on a stable regimen as defined by no medication changes for these drugs in prior 4 weeks.

Exclusion Criteria:

Evidence of atypical parkinsonism.
Contra-indications to MR imaging including but not limited to pacemakers, aneurysm clips, intraocular metal, cochlear implant, or severe claustrophobia.
Evidence of large vessel stroke or mass lesion on MRI.
Regular use of typical anti-cholinergic drugs.
Recent history of significant, uncontrolled GI disease such as GERD, colorectal cancer.
Significant metabolic or uncontrolled medical comorbidity.
Pregnant 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 would preclude safe and meaningful participation in the study.

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tributyrin Supplementation

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.

Interventions

Tributyrin

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

Placebo

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

Primary outcome measure

Single composite global cognitive z-score [ Time Frame: Baseline and post-intervention (83-97 days after starting supplement) ]
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III Score [ Time Frame: Baseline and post-intervention (83-97 days after starting supplement) ]
Safety and tolerability of tributyrin [ Time Frame: During and after 83-97 day supplementation period ]

Central Contacts and Locations

Central contacts

Robert Vangel, BSc

734-936-1168 rvangel@med.umich.edu

Locations

Domino's Farms

Recruiting

Ann Arbor, Michigan, United States, 48105

Contacts

Robert Vangel, BSc

734-936-1168 rvangel@med.umich.edu

Principal Investigator:

Prabesh Kanel, PhD

More Information

Sponsor

Prabesh Kanel

Last update posted

Nov 12, 2025

Last verified

Nov, 2025

Keywords

short chain fatty acid
butyrate
tributyrin
functional neuroimaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Prabesh Kanel on 2025-11-12.