Tributyrin for Progressive Supranuclear Palsy
(BUTTER2 Trial)
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either 500mg tributyrin or placebo three times a day for 90 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Participants will take 500mg three times a day (TID) tributyrin supplement for 90 days +/- 7 days.
Participants will take 500mg placebo for 90 days +/- 7 days.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Prabesh Kanel
Lead Sponsor
Farmer Family Foundation
Collaborator
Citations
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synapse.patsnap.com
synapse.patsnap.com/article/fda-grants-fast-track-to-ferrers-fnp-223-for-progressive-supranuclear-palsyFDA Grants Fast Track to Ferrer's FNP-223 for Progressive ...
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coherentmarketinsights.com
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Early trial results are promising: TauRx's Phase 3 tests with LMTM showed small improvements in thinking for PSP patients, leading to wider ...
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amazon.com
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This item is non-returnable due to potential safety risk as an ingestible product, but if the item arrives damaged or defective, you may request a refund or ...
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reddit.com
reddit.com/r/SiboSuccessStories/comments/1prbyu3/tributyrin_game_changer_for_methane_hydrogen/Tributyrin: game changer for Methane + Hydrogen Sulfide ...
I have been struggling with Post Covid Methane + Hydrogen Sulfide SIBO/IMO for 5 years; my BM were so scarce and difficult that I felt ...
Tributyrin alleviates gut microbiota dysbiosis to repair ... - PMC
Tributyrin (TB) is a butyric acid precursor and has a key role in anti-inflammatory and intestinal barrier repair effects by slowly releasing ...
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