Parkinson's Research In Metagenomic Early Stage Biomarkers
Key facts
- Where
- Cassino and Rome, ItalySee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 35 and 80 years old?
Source: NCT07097103, who can take part
Where in Italy
- Casa di Cura San Raffale CassinoCassino, ItalyNo longer taking part
- IRCCS San Raffale RomaRome, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- IRCCS San Raffaele Roma
- Trial code
- NCT07097103
- Record updated
- 30 July 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Chronic corticosteroid therapy; Use of proton pump inhibitors within the past 30 days; Prolonged intake of anxiolytic drugs, antidepressants, antipsychotics, cognitive stimulants, and analogs in the past 3 months; Use of experimental products in the 3 months prior to the screening visit; Pre-existing psychiatric disorders; Any other neurological or neurodegenerative disorders; Dementia diagnosis; Type1 Diabetes Mellitus; Type 2 diabetes mellitus with HbA₁c ≥ 8% or on insulin therapy; Acute diseases; Celiac disease; History of major gastrointestinal surgery or acute GI conditions (e.g., gastroenteritis) within the past 3-6 months; Acute, antibiotic-resistant infections; History of deep brain stimulation (DBS) surgery; Atypical or secondary Parkinsonism; Presence of pacemakers or other subcutaneous electronic devices; Moderate to severe cognitive decline; Beck Depression Inventory-II (BDI-II)] score ≥28; Thyroid dysfunctions; Active Neoplasia; IBD or IBS; Antibiotic intake within the past 30 days; Prebiotic/probiotic supplement use in the past 30 days; Underweight (BMI <18.5); Pregnancy or lactation; Regular use of enemas or suppositories to alleviate constipation; Patients who, for medical reasons, are required to follow special dietary regimens that could interfere with the adoption or effectiveness of the Mediterranean model; Vegan/Vegetarian diet or any other dietary behaviour that excludes one or more of the typical food groups of the Mediterranean model.