Actively Recruiting

Age: 20Years - 90Years
All Genders
Healthy Volunteers
NCT05934188

Exploring the Gut-Brain Axis in Ageing and Neurodegeneration

Led by IRCCS San Camillo, Venezia, Italy · Updated on 2026-01-09

200

Participants Needed

3

Research Sites

208 weeks

Total Duration

On this page

Sponsors

I

IRCCS San Camillo, Venezia, Italy

Lead Sponsor

I

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Collaborating Sponsor

AI-Summary

What this Trial Is About

Neurodegenerative diseases are a major health concern due to their growing societal implications and economic costs. The identification of early markers of pathogenic mechanisms is one of the current main challenges. The gut-brain axis has become a primary target because of its transversal role across the neurodegenerative spectrum and its effect on cognition. However, despite recent progress, how changes in the gut-microbiota composition can affect the human brain is still unclear. The goal of this observational study is to characterise the gut-microbiota composition associated with alterations in brain structure and function during the ageing process and across neurodegenerative disorders. This is based on recent studies showing that changes in the human brain and in the microbiota composition, can indicate very sensitively and in a predictive way pathological development and, consequently, be used as markers of neurodegenerative diseases. The main questions it aims to answer are: * How variation in the gut-microbiota composition correlates with the normal brain ageing trajectory? * How dysregulation in the gut-microbiota correlates with pathological changes in brain regions in specific neurodegenerative disorders? * Can the impact of the gut-microbiota on the brain be modulated by blood biomarkers? The investigators will recruit 40 young healthy participants, 40 old healthy participants, 40 participants with prodromal Alzheimer's Disease, 40 participants with Parkinson's Disease and 40 participants with Multiple Sclerosis. Participants will undergo the following examinations: * Magnetic Resonance Imaging * Analysis of a stool sample * Analysis of a blood sample * Neuropsychological assessment * Questionnaires on eating habits

CONDITIONS

Official Title

Exploring the Gut-Brain Axis in Ageing and Neurodegeneration

Who Can Participate

Age: 20Years - 90Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 20 and 50 years or between 60 and 90 years for healthy subjects
  • Cognitively healthy individuals with Mini-Mental State Examination score of 26 or higher for healthy subjects
  • No significant neurological disorders for healthy subjects
  • Subjective cognitive complaints confirmed by an informant for prodromal Alzheimer's Disease patients
  • Episodic memory deficits on neuropsychological testing for prodromal Alzheimer's Disease patients
  • Clinical Dementia Rating score of 0.5 for prodromal Alzheimer's Disease patients
  • Mini-Mental State Examination score above 23 for prodromal Alzheimer's Disease patients
  • Independent functioning in daily activities for prodromal Alzheimer's Disease patients
  • Recent diagnosis of Parkinson's Disease for Parkinson's patients
  • Mild to moderate score on the Unified Parkinson's Disease Rating Scale for Parkinson's patients
  • Cognitively healthy with Mini-Mental State Examination score of 26 or higher for Parkinson's patients
  • Stable medication dosage for Parkinson's patients if taking treatment for at least 6 months
  • Recent diagnosis of relapsing-remitting Multiple Sclerosis for Multiple Sclerosis patients
  • Expanded Disability Status Scale score of 4.0 or less for Multiple Sclerosis patients
  • Cognitively healthy with Mini-Mental State Examination score of 26 or higher for Multiple Sclerosis patients
  • Stable medication dosage for Multiple Sclerosis patients if taking treatment for at least 6 months
Not Eligible

You will not qualify if you...

  • Contraindications to magnetic resonance imaging such as metal implants, claustrophobia, or pacemakers
  • Presence of severe comorbidities
  • Use of antibiotics treatment within the last 3 months

AI-Screening

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Trial Site Locations

Total: 3 locations

1

IRCCS San Camillo

Venice-Lido, Venice, Italy, 30126

Actively Recruiting

2

IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli

Brescia, Italy, 25125

Actively Recruiting

3

Università Ca' Foscari Venezia

Venice, Italy, 30123

Actively Recruiting

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Research Team

N

Nicola Filippini

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

5

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