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 @ 11:51 PM
Ignite Modification Date:
2025-12-24 @ 11:51 PM
NCT ID:
NCT05313451
Eligibility Criteria:
Main Inclusion Criteria:
* Subject with a body mass index (BMI) of 18.0-30.0 kg/m 2
* Subject with regular upper respiratory tract infections(nasopharyngitis, flu-like illness, flu, cold...)
* Subject accepting the anti-influenza virus vaccination
* Subject agreeing to maintain lifestyle and dietary habits over the study
Main Exclusion Criteria:
* Subject having had the flu during the current season
* Subject having presented a viral or bacterial infection in the past 7 days prior to inclusion
* Subject with a known allergy to one of the compounds of products administered in the study or in accordance with indications of the vaccine
* Subject having presented manifestations of allergy during previous flu vaccinations
* Subject with ongoing gastrointestinal disease or chronic gastrointestinal disease (IBS, Crohn's disease, etc.)
* Suffering from diabetes, an autoimmune disease, a disease inflammation or a major or progressive pathology
* Pregnant women (negative urine pregnancy test for women of childbearing age), breastfeeding or planning a pregnancy in the coming months
* Subject who has already received the influenza vaccine for the current season
* Subject having received any vaccination during the last month prior to inclusion
* Subject who received antibiotic therapy within the last two month
* Taking any dietary supplements or enriched foods that are presented as having an action on immunity and/or on the intestinal sphere (prebiotics, probiotics, vitamins, plant extracts...) in the last month.
* Taking immunomodulatory or immunosuppressive drugs
* Taking any treatment that the investigator believes may interfere with investigation endpoints.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
70 Years
Study:
NCT05313451
Study Brief:
Protocol Section:
NCT05313451