Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-28 @ 5:25 AM
Study NCT ID:
NCT07097103
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-31
First Post:
2025-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Parkinson's Research In Metagenomic Early Stage Biomarkers
Sponsor:
IRCCS San Raffaele Roma
Organization:
Study Overview
Official Title:
A 2x2 Factorial Randomized Controlled Non-pharmacological Interventional Multicenter Pilot Study on the Influence of the Mediterranean Diet and Physical Exercise on the Microbiome of Patients With Parkinson's Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRIME_2025
Brief 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.
Detailed Description:
The study will last 60 months, and the following activities are planned:
* Study presentation, selection and enrollment of patients;
* Evaluation of patients' health and nutritional status, including collection of physiological, pathological, and pharmacological history;
* Randomization of patients into four groups;
* Sample collection and storage;
* Microbiome analysis;
* Evaluation of motor and non-motor symptoms using clinical tests and rating scales at baseline (T0), at six months (T1) after treatment initiation, and at three and six months post-intervention (FU1 and FU2, respectively).
* Study presentation, selection and enrollment of patients;
* Evaluation of patients' health and nutritional status, including collection of physiological, pathological, and pharmacological history;
* Randomization of patients into four groups;
* Sample collection and storage;
* Microbiome analysis;
* Evaluation of motor and non-motor symptoms using clinical tests and rating scales at baseline (T0), at six months (T1) after treatment initiation, and at three and six months post-intervention (FU1 and FU2, respectively).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: