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

Parkinson Disease Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04854291
Study type Interventional
Source Helsinki University Central Hospital
Contact
Status Completed
Phase N/A
Start date April 25, 2021
Completion date June 13, 2023
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