Phase
Condition
N/ATreatment
Infant Formula
Clinical Study ID
Ages < 14 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Healthy, singleton, term born infants (gestational age ≥ 37 weeks + 0 days and ≤ 41weeks + 6 days).
Infants aged ≤ 14 days at enrolment.
Weight at birth within 10th to 90th percentile per gestational age and sex,according to Intergrowth Standards
For formula feeding groups: Infants fully formula fed at the time of enrolment.
For breastfed reference group: Infants exclusively breastfed at the time ofenrolment and parent(s) intend to exclusively breastfeed the infant at least until 16 weeks after Visit 1.
Written informed consent (IC) from parent(s) and/or legally acceptablerepresentative(s) aged ≥18 years at enrolment.
Exclusion
Exclusion Criteria:
. Infants who require a special diet other than IF with intact cow's milk protein.
Infants known or suspected to have cow's milk, fish, and/or soy allergy and/orlactose intolerance.
Infants with current or previous illnesses/conditions and/or known or suspectedcongenital diseases or malformations which could interfere with the study outcomes,as per investigator's clinical judgement.
Infants whose mother is known to suffer from an illness or condition which couldinterfere with the study outcomes, as per investigator's clinical judgement.
Infants with previous, current, or intended participation in any concomitantclinical study involving investigational or marketed products.
Investigator's uncertainty about the willingness or ability of parents or legallyacceptable representative(s) to comply with the protocol requirements.
Study Design
Study Description
Connect with a study center
Medical Centre Asklepiy OOD Dupinista
Dupnitsa, 2600
BulgariaActive - Recruiting
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