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 @ 3:39 AM
Ignite Modification Date:
2025-12-25 @ 3:39 AM
NCT ID:
NCT02096302
Eligibility Criteria:
Inclusion Criteria:
* Full-term healthy newborns (\>= 37 weeks)
* Birth weight between \>=2.500g and \<=4.500g)
* Normal growth curve (between 3-97 percentiles)
* 0-60 days of age on enrolment
* Maximum 30 days of breastfeeding
* Exclusively infant formula on enrolment
* Breastfeeding or infant formula with pre/probiotics feeding stopped 15 days before enrolment
* Parents or caregivers agree to exclude any source of prebiotics or probiotics during the study
* Parents or caregivers agree to follow-on the study 12 weeks
* Informed consent signed ( Parent/Legal representative)
Exclusion Criteria:
* Congenital illness or malformation that may affect infant feeding and /or normal growth
* Significant pre-natal or post-natal diseases
* Infant's family history of atopy
* Any pathology related to the immune or gastrointestinal system.
* Suspected or known allergy to cow's milk protein
* Infants receiving pre or probiotics within less than 15 days prior to enrolment
* Infant's family who in the investigator's assessment cannot be expected to comply with the protocol
Healthy Volunteers:
True
Sex:
ALL
Maximum Age:
90 Days
Study:
NCT02096302
Study Brief:
Protocol Section:
NCT02096302