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Parkinson's Research In Metagenomic Early Stage Biomarkers

Study acronym: PRIME_2025
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Start date: Sep 1, 2025 to Sep 1, 2026
    • Study sites: 0 to 2
    • Collaborators: 1 to 3
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
(from sponsor)		 Parkinson's Disease (PD)
Related terms Motor Activity
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov