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

Helsinki University Central Hospital · 2021
ClinicalTrials.gov · Datasets · License: Public Domain · 2021
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gut-brain-axismicrobiotanaparkinson-diseaseparkinson-s-disease
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.
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