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NCT07097103Not yet recruiting

Parkinson's Research In Metagenomic Early Stage Biomarkers

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

Source: ClinicalTrials.gov · Last updated 30 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
80 (estimated)
First submitted
30 Jun 2025
Start date
1 Sept 2026
Primary completion date
11 Jul 2029
Lead sponsor
IRCCS San Raffaele Roma
NCT number
NCT07097103

What you commit to

  • Study type: Interventional
  • Planned participants: 80
  • From 1 Sept 2026 to the primary completion date, 11 Jul 2029
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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;

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 35 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Casa di Cura San Raffale Cassino
Coordinator of this site? Confirm its status		CassinoItalyUnknown status
IRCCS San Raffale Roma
Coordinator of this site? Confirm its status		RomeItalyUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.