Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT04461951
Eligibility Criteria:
Inclusion Criteria:
* attending a medical appointment in the research facility
* living at home in one of the two municipalities
* being 65+ years
Exclusion Criteria:
i) neuropsychological criteria:
* subject with dementia, pre-existing cognitive impairment (e.g. aphasia, neglect), concomitant severe psychiatric disease, others neurological conditions (e.g. severe depression and behavioral disorders)
* severe sensory disturbances (e.g. auditory and/or visual loss) that do not allow completing neuropsychological assessment
ii) microbiota' analysis protocol:
* individuals with artificial nutrition in progress
* history of active uncontrolled gastrointestinal disorders or diseases (inflammatory bowel disease, ulcerative colitis, and Crohn's disease)
* subjects who underwent previous major surgery on the gastro-enteric tract, with the exception of cholecystectomy and appendectomy, in the past five years
* use of antibiotics or large doses of commercial probiotics in the 4 weeks prior the visit
* subjects under radio-chemo-therapy
iii) MRI scanning protocol:
* subjects with metal fragments in the body, surgically implanted devices containing metal
* severe claustrophobia
* inability to lie down in the MRI scanner for the duration of the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT04461951
Study Brief:
Protocol Section:
NCT04461951