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 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT01431469
Eligibility Criteria:
Inclusion Criteria:
* Child 12-48 months of age
* Has consumed cow's milk or a cow's milk-based beverage during the 48 hours prior to randomization
* Signed informed consent
Exclusion Criteria:
* Child who is receiving predominantly breast-milk
* Child who received any food product or supplement containing probiotics or prebiotics in the 15 days prior to randomization
* Child with allergy to gluten or serious concurrent illness that will interfere in the general management of the child
* Child with diarrhea or acute respiratory infection during the 48 hours prior to randomization
* Child's z-score of weight for length/height \< -3 according to World Health Organization criteria
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
48 Months
Study:
NCT01431469
Study Brief:
Protocol Section:
NCT01431469