NCT04854291

A Trial of Fecal Microbiome Transplantation in Parkinson's Disease Patients

A Randomized, Double Blind, Placebo Controlled Multicenter Trial of Fecal Microbiome Transplantation Safety and Efficacy for Parkinson's Disease Patients With Abnormal Gut Microbiota Composition

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

48 PD patients (age 35-75y; H\&Y 1-3) testing positive in a stool PD-dysbiosis test will be randomized in a 2:1 ratio to receive either donor FMT or their own stool through intracaecal infusion. The main outcome measure will be the sum of MDS-UPDRS I-III at 6 months to cover motor and non-motor symptom changes. A wide array of secondary clinical outcome measures will be assessed longitudinally and a large array of measurements, biospecimens (stool, urine, blood, colonic biopsies), and imaging data will be collected for further analysis at baseline, 1, 6, and 12 months.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
OTHER	Administration of donor FMT	Intracaecal infusion of FMT
OTHER	Administration of placebo	Intracaecal infusion of carrier solution

Timeline

• Start date: 2021-04-25
• Primary completion: 2022-12-27
• Completion: 2023-06-13
• First posted: 2021-04-22
• Last updated: 2024-10-10

Locations

4 sites across 1 country: Finland