drugset / Trial / NCT05446168

Brain Small Chain Fatty Acid Metabolism in Parkinson Disease: Tributyrin Supplementation

NCT05446168 ↗

Phase 1 Terminated 18 enrolled Nicolaas Bohnen, MD, PhD
Non-randomizedParallel-groupOpen-labelTreatment

Summary

Small exploratory open-label pilot study to assess the short-chain fatty acid (SCFA) prodrug tributyrin as a potential therapy for persons with Parkinson disease

Timeline

Start
2022-07-01
Primary completion
2023-09-26
Completion
2023-09-26

Outcome

Mixed primary results

Stopped (Business): “Withdrawal of funding”

registry analysis (other test); Parkinson's Disease Tributyrin Intervention; p = 0.005; Mean Difference (Net) -0.08 (95% CI -0.12 to -0.03); t-test, 2 sided NCT05446168 ↗

registry Lower radiotracer binding is interpreted to reflect higher levels of (non-tracer) butyrate in the brain NCT05446168 ↗

registry analysis (other test); Parkinson's Disease Tributyrin Intervention; p = 0.27; Mean Difference (Net) 4.33 (95% CI -3.81 to 12.47); t-test, 2 sided NCT05446168 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject tributyrin Other / unclassified 500 mg —

Indications