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 @ 3:35 PM
Ignite Modification Date:
2025-12-24 @ 3:35 PM
NCT ID:
NCT02776592
Eligibility Criteria:
Inclusion Criteria:
* Health child, 4-5 years of age
* Born as full-term (Gestational age of 37-42 weeks)
* Consumed cow's milk or a cow's milk-based beverage during the 48 hours prior to the baseline visit
* Parents or legal guardian agrees not to feed child any food products or supplements containing probiotics or prebiotics
* Signed informed consent
Exclusion Criteria:
* History or known or suspected cow milk protein intolerance
* Child who has received any food product ot supplement containing probiotics or prebiotics (with the exception of yogurt) in the 15 days prior to the baseline visit
* Serious concurrent illness that will interfere in the general management of the child
* History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised
* Child's z-score of weight for height at baseline is \< -3 according to WHO criteria
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
5 Years
Study:
NCT02776592
Study Brief:
Protocol Section:
NCT02776592