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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
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.
Age
35 - 75 years
Sex
ALL
Healthy Volunteers
No
Helsinki University Central Hospital
Helsinki, Finland
Päijät-Häme Central Hospital
Lahti, Finland
Tampere University Hospital
Tampere, Finland
Turku University Hospital
Turku, Finland
Start Date
April 25, 2021
Primary Completion Date
December 27, 2022
Completion Date
June 13, 2023
Last Updated
October 10, 2024
51
ACTUAL participants
Administration of donor FMT
OTHER
Administration of placebo
OTHER
Lead Sponsor
Helsinki University Central Hospital
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06113640