Printed from Voxsanity (voxsanity.com.au) — NCT07097103 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
Back to Parkinsons Disease
Parkinson's Disease Trial, Not Yet Recruiting
NCT07097103
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- A person must have been diagnosed with Parkinson's disease using a specific set of recognised diagnostic standards known as the UK Parkinson's Disease Society Brain Bank criteria.
- A person must be between 35 and 80 years of age.
- A person's Parkinson's symptoms must fall within a mid-range of severity (neither very mild nor severe) when their medication is working well, based on a standard rating scale called Hoehn & Yahr.
- A person must score at or above a certain level on a standard thinking and memory test called the MoCA (a score of 17.54 or higher).
- A person must score 24 or higher on another standard thinking and memory test called the MMSE.
- A person must have been on a stable Parkinson's medication dose for at least 4 weeks before joining.
- A person must be able to communicate with the research team and give informed consent in Italian.
- A person must be considered medically suitable to take part in physical exercise.
- A person must be able to walk without any walking aids such as a cane or walker.
- A person must be willing and able to follow all study procedures throughout the trial.
- A person must be willing to keep their usual eating habits during a period of at least 4 weeks before the trial officially begins.
- A person must be willing to change to a Mediterranean-style diet during the trial.
- A person must be able to provide stool samples at each required collection point during the trial.
- A person must be willing to avoid intense exercise and alcohol for 24 hours before each study visit.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who have a pre-existing psychiatric disorder.
- People who have an atypical or secondary form of Parkinsonism (types of movement disorders that are not standard Parkinson's disease).
- People who have a pacemaker or any other electronic device implanted under the skin.
- People who have any other neurological or brain-related degenerative conditions.
- People who have moderate to severe cognitive (thinking and memory) decline.
- People who score 28 or higher on a standard depression questionnaire called the Beck Depression Inventory-II.
- People who have been diagnosed with dementia.
- People who have a thyroid disorder.
- People who have Type 1 Diabetes.
- People who have Type 2 Diabetes with poor blood sugar control (HbA1c of 8% or higher) or who use insulin.
- People who have an active acute illness at the time of the trial.
- People who have an active cancer diagnosis.
- People who have inflammatory bowel disease (IBD) or irritable bowel syndrome (IBS).
- People who have coeliac disease.
- People who have had major bowel or stomach surgery, or a recent stomach or gut illness such as gastroenteritis, within the past 3 to 6 months.
- People who are on long-term corticosteroid (steroid) medication.
- People who have used proton pump inhibitors (a type of medication for stomach acid) within the past 30 days.
- People who have an active infection that does not respond to antibiotics.
- People who have taken antibiotics within the past 30 days.
- People who have used prebiotic or probiotic supplements within the past 30 days.
- People who have regularly taken anxiolytics, antidepressants, antipsychotics, cognitive stimulants, or similar medications over the past 3 months.
- People who are underweight, meaning a BMI below 18.5.
- People who have had deep brain stimulation (DBS) surgery in the past.
- People who are pregnant or breastfeeding.
- People who regularly use enemas or suppositories to manage constipation.
- People who have used an experimental product within the 3 months before the screening visit.
- People who, for medical reasons, are required to follow a special diet that could interfere with switching to or benefiting from a Mediterranean-style diet.
- People who follow a vegan or vegetarian diet, or any other eating pattern that removes one or more food groups that are a standard part of the Mediterranean diet.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.
Contact this trial
Phone: +39 0652253440
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Not Yet Recruiting
Phase
Not Applicable
Sponsor
IRCCS San Raffaele Roma
Registry
ClinicalTrials.gov
Start date
1 September 2025
Est. completion
11 July 2029
Primary endpoints
Alpha Diversity of the fecal microbiota.; Beta Diversity of the fecal microbiota; Enterobacteriaceae species abundance across Parkinson's disease stage; Fecal Microbial relative quantification
Can't join this trial?
Data last synced from ClinicalTrials.gov: 10 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.