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 @ 1:30 AM
Ignite Modification Date:
2025-12-25 @ 1:30 AM
NCT ID:
NCT06256094
Eligibility Criteria:
Inclusion Criteria:
* Healthy and term infants (37-42 weeks gestation);
* Birth weight between 2500g and 4500g;
* 60-120 days of age after birth;
* Mixed-fed: Infants who were fed with a mixture of formula and human milk, and received daily formula consumption of more than 400ml;
* Signed informed consent obtained form the guardian(s) of the infants;
* Parent or guardian of infant agrees not to enroll infant in another interventional clinical research survey while participating in this survey.
Exclusion Criteria:
* Congenital anomaly or hereditary/chronic/congenital diseases that could interfere with the study product evaluations;
* Evidence of feeding difficulties or intolerance/allergy to cow's milk;
* Conditions requiring infant feedings other than those specified in the protocol;
* Significant systemic disorders (cardiac, respiratory, endocrinological, hematologic, gastrointestinal, or other) or parental refusal to participate;
* Acute infection or gastroenteritis at the time of enrollment;
* Participation in other clinical trials at the time of the study;
* Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Days
Maximum Age:
120 Days
Study:
NCT06256094
Study Brief:
Protocol Section:
NCT06256094