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 @ 11:19 PM
Ignite Modification Date:
2025-12-24 @ 11:19 PM
NCT ID:
NCT02028156
Eligibility Criteria:
Inclusion Criteria:
Inclusion Criteria for Stage 1:
* Singleton full term birth with birth weight of \> 2500g.
* Infant between 0 and 60 days of age.
* Discontinuation of medications that might affect gastrointestinal (GI) tolerance.
* Infant is exclusively formula-fed a full-lactose, intact cow milk protein-based infant formula (CMF) for less than 7 days prior to enrollment.
Inclusion Criteria for Stage 2:
* Infant was fed according to protocol in Stage 1 of the study.
* Infant was identified as being fussy using the Intolerance Assessment Tool in Stage 1.
Exclusion Criteria:
Exclusion Criteria for Stage 1:
* Chromosomal or major congenital anomalies.
* Suspected or known metabolic or physical diseases affecting infant feeding and/or metabolism.
* Hospitalization, other than for delivery, prior to enrollment.
* Severe uncontrolled eczema, visible bloody stools or milk protein allergy prior to enrollment.
* More than 1 substitution of an infant formula other than full-lactose, intact cow milk formula (CMF) since birth.
* Use of a prokinetic drug within 7 days before enrollment.
Exclusion Criteria for Stage 2:
* Infant's intolerance symptom was caused by another reason, for example known infection/illness, food allergy, or response to vaccination(s).
* Infant has immunization(s) within 3 days of enrollment in Stage 2.
Healthy Volunteers:
True
Sex:
ALL
Maximum Age:
60 Days
Study:
NCT02028156
Study Brief:
Protocol Section:
NCT02028156