Parkinson's Research In Metagenomic Early Stage Biomarkers

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-80
SponsorIRCCS San Raffaele Roma

About this trial

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.

Eligibility criteria

Qualifiers

Diagnosis of Parkinson's disease according to United Kingdom (UK) Parkinson's Disease Society Brain Bank criteria;

aged 35-80 years;

Hoehn & Yahr stage > 1 and < 3 in the clinical "ON" state;

MoCA score ≥17.54;

Disqualifiers

Pre-existing psychiatric disorders;

Atypical or secondary Parkinsonism;

Presence of pacemakers or other subcutaneous electronic devices;

Any other neurological or neurodegenerative disorders;

Trial design

Treatments tested in this trial

  • Mediterranean Diet Intervention
  • Intensive Physical Activity Intervention
  • Control

Treatment groups

80 Participants
are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

IRCCS San Raffaele Roma

Lead sponsor

San Raffaele Cassino, Cassino, Italy

Collaborator