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 @ 3:22 AM
Ignite Modification Date:
2025-12-25 @ 3:22 AM
NCT ID:
NCT02456805
Eligibility Criteria:
Inclusion Criteria:
* Infants formula-fed exclusively and experiencing symptoms of cow's milk formula intolerance.
* Infants whose physicians had made a recommendation that the parents change the infant's feeding.
* Full term infants at birth with a gestational age of 37 to 42 weeks.
* Infants 2- 9 weeks of age at study entry with birth weights greater than 2500 grams.
Exclusion Criteria:
* Infants with a maternal medical history which had adverse effects on the fetus, such as diabetes, tuberculosis, perinatal infections, or substance abuse.
* Infants with evidence of cardiac, respiratory, gastrointestinal, hematological, or metabolic disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Weeks
Maximum Age:
9 Weeks
Study:
NCT02456805
Study Brief:
Protocol Section:
NCT02456805