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

NCT04854291 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2024-10-10

No results posted yet for this study

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

OTHER

Administration of donor FMT

Intracaecal infusion of FMT

OTHER

Administration of placebo

Intracaecal infusion of carrier solution

Sponsors & Collaborators

  • Turku University Hospital

    collaborator OTHER_GOV

  • Tampere University Hospital

    collaborator OTHER

  • University of Helsinki

    collaborator OTHER

  • Central Hospital of Paijat-Hame

    collaborator UNKNOWN

  • University of Aarhus

    collaborator OTHER

  • Helsinki University Central Hospital

    lead OTHER

Principal Investigators

  • Filip Scheperjans, MD · Helsinki University Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-25
Primary Completion
2022-12-27
Completion
2023-06-13

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04854291 on ClinicalTrials.gov