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 @ 3:36 PM
Ignite Modification Date:
2025-12-24 @ 3:36 PM
NCT ID:
NCT01731392
Eligibility Criteria:
Inclusion Criteria:
* Parents written and signed informed consent for participation in the study.
* Healthy children aged 1 to 3 years that are no more breastfed.
* Go to a selected nursery and / or pediatrician.
* Parents must have a phone at home or a cellular phone to call the paediatrician.
* No consumption of commercial products containing probiotics or prebiotics during the 3 weeks before and during the study period.
* Parents are able to give their children, twice daily, 2 milk servings on a 5 months period.
* Children not being intensive consumers of regular yoghurts
Exclusion Criteria:
* Rotavirus and flu vaccines administration within the last 3 months prior to V1 (baseline visit).
* Used antibiotics within the last 30 days prior to V1 (baseline visit).
* Congenital or chronic disease.
* Any kind of immunodeficiency or allergy, milk protein allergy or lactose intolerance.
* Significant illness within the two weeks prior to start of the study or any active systemic infection or medical condition that may require treatment or therapeutic intervention during the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
3 Years
Study:
NCT01731392
Study Brief:
Protocol Section:
NCT01731392