Not Yet RecruitingNot Applicable

Parkinson's Research In Metagenomic Early Stage Biomarkers

80 participantsStarted 2025-09-01

Plain-language 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.

Who can participate

Age range35 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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; * MMSE ≥24; * Stable dopaminergic midication regimen for ≥ 4 weeks; * Ability to interact with the research team and provide informed consent in Italian; * Suitable to physical exercise; * Able to walk unassisted (no walking aids); * Willingness and ability to comply with all study procedures; * Willingness to maintain usual diet during a ≥ 4-week pre-baseline period; * Willingness to switch to a Mediterranean-style diet during the intervention; * Ability to provide stool samples at each collection timepoint; * Willing to avoid strenuous exercise and alcohol for 24 hours prior to each visits. Exclusion Criteria: * Pre-existing psychiatric disorders; * Atypical or secondary Parkinsonism; * Presence of pacemakers or other subcutaneous electronic devices; * Any other neurological or neurodegenerative disorders; * Moderate to severe cognitive decline; * Beck Depression Inventory-II (BDI-II)\] score ≥28; * Dementia diagnosis; * Thyroid dysfunctions; * Type1 Diabetes Mellitus; * Type 2 diabetes mellitus with HbA₁c ≥ 8% or on insulin therapy; * Acute diseases; * Active Neoplasia; * IBD or IBS; * Celiac disease; * History of major gastrointestinal surgery or acute GI conditions (e.g., gastroenteritis) within the past 3-6 months; * Chronic cort…

What they're measuring

Alpha Diversity of the fecal microbiota.

Timeframe: Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)

Beta Diversity of the fecal microbiota

Timeframe: Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)

Enterobacteriaceae species abundance across Parkinson's disease stage

Timeframe: Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)

Fecal Microbial relative quantification

Timeframe: Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)

Trial details

NCT IDNCT07097103

SponsorIRCCS San Raffaele Roma

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-07-11

Contact for this trial

Alice Fognani

+39 0652253440 alice.fognani@uniroma5.it

View on ClinicalTrials.gov More Parkinson's Disease (PD) trials

Plain-language summary

Who can participate

Age range35 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Alpha Diversity of the fecal microbiota.

Timeframe: Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)

Beta Diversity of the fecal microbiota

Timeframe: Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)

Enterobacteriaceae species abundance across Parkinson's disease stage

Timeframe: Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)

Fecal Microbial relative quantification

Timeframe: Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)