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 @ 2:58 AM
Ignite Modification Date:
2025-12-25 @ 2:58 AM
NCT ID:
NCT03489733
Eligibility Criteria:
Inclusion Criteria:
* Healthy term-born male and female infants (gestational Age ≥37+0, singleton birth)
* Birth weight ≥ 2500 g and ≤ 4500 g
* Age at enrollment: ≤ 56 days of life
* At risk of developing atopic diseases
* Free of atopy symptoms at Screening and at any time before randomization
* Feeding regimen at any time before Screening (V1) and Baseline (V2, infants who will receive Interventional Product (IP)): no infant formula feeding and solid foods allowed (in order to exclude prior sensitization) except amino acid formula (e.g. Neocate Infant), maltodextrin or glucose solution/gel; breastfeeding allowed
* Subject's parents/caregivers willing to comply with the feeding regimen during the intervention period. Subject's parents/caregivers will decide which feeding regimen will be used (IP or breast milk):
* IP regimen (intervention or control group): only IP and breast milk until at least 120 days of life
* breastfeeding regimen (reference group): exclusively breast milk until at least 120 days of life.
* No other infant formulas or solid foods are allowed.
* Written informed consent.
Exclusion Criteria:
* Multiple births
* Premature delivery (gestational age ≤ 36+6)
* Neonatal illnesses that might have an impact on allergy development (based on Investigator's decision)
* Significant congenital abnormalities
* Participation in another clinical study with an IP or study method that would influence the outcome of this study
* Reason to presume that the subject's parents/caregivers are unable to meet study plan requirements.
Healthy Volunteers:
True
Sex:
ALL
Maximum Age:
56 Days
Study:
NCT03489733
Study Brief:
Protocol Section:
NCT03489733