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:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-25 @ 3:29 AM
NCT ID:
NCT04596605
Eligibility Criteria:
Inclusion Criteria:
* Informed consent signed and dated
* Volunteer with no history of gastrointestinal disorders
* Volunteer agreeing not to consume a food supplement other than IP during the study period
* Registered, or agreeing to be registered, in the National Registry of Healthy Volunteers
Exclusion Criteria:
* Any known or suspected hypersensitivity or allergy
* History of or active severe chronic disease or relevant systemic condition incompatible with the study
* Pregnancy or breast-feeding or have planned pregnancy in the next 4 months
* Childbearing potential woman neither surgically sterilized nor using an adequate contraception
* Inability of the subject to understand the study procedures or to give informed consent
* Non-compliant subject
* Participation in this study at the same time as another clinical investigation/study
* Subject having received, during the last 12 months, indemnities for clinical trial higher or equal to 4500 Euros
* Subject being institutionalized because of legal or regulatory order, inmate of psychiatric wards, prison or state institutions, or employee of the study site or of the Sponsor's company
* Subject not covered by the government health care scheme of the country in which he/she is living
* Subject with previous, current or anticipated prohibited treatment
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT04596605
Study Brief:
Protocol Section:
NCT04596605