Parkinson's Research In Metagenomic Early Stage Biomarkers (NCT07097103) | Clinical Trial Compass
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 range
35 Years – 80 Years
Sex
ALL
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying gut bacteria in people with Parkinson's disease — specifically looking at things like microbial diversity and Enterobacteriaceae levels — so would my current stage of Parkinson's make me a relevant candidate to discuss participating in this kind of research?
2Since this study is listed as 'not yet recruiting,' how long might it realistically be before it opens, and is there any reason to wait for it versus pursuing other options now?
3This appears to be a biomarker study rather than a treatment trial — meaning it's collecting data rather than testing a therapy — so what would I actually gain personally from joining, and how does that weigh against simply focusing on my current treatment plan?
4The trial is measuring fecal microbiota, which involves stool sample collection — what does that process typically look like in practice, and is that something you think would fit my situation?
5Given that researchers are looking at gut bacteria across different stages of Parkinson's, do you think findings from this kind of study could eventually influence how my disease is monitored or treated, and is this the right moment in my care to get involved in observational research like this?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)
2
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)
3
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)
4
Fecal Microbial relative quantification
Timeframe: Baseline (Week 0); End of intervention (Week 24); First Follow-up (Week 36); Second Follow-up (Week 48)