Clinical Trial

Parkinson's Research In Metagenomic Early Stage Biomarkers

Study acronym: PRIME_2025
Not Yet Recruiting
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Summary
This 2x2 factorial, randomized, controlled pilot study aims to identify a specific microbiota pattern, which could constitute a biomarker of Parkinson's disease, and to evaluate whether specific pathotypes can be associated with different stages of the disease; furthermore, the investigators are committed to evaluating how and to what extent the changes induced by a personalized nutritional intervention combined with physical exercise affect the symptoms and quality of life of patients.
Trial Details
NCT Number NCT07097103
Lead Sponsor IRCCS San Raffaele Roma
Collaborators: San Raffaele Telematic University, University of Urbino "Carlo Bo", Northwestern University
Conditions Parkinson's Disease (PD)
Enrollment 80 participants
Start Date 2026-09-01
Primary Completion 2029-07-11 (estimated)
Study Completion 2029-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-30