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 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT01143233
Eligibility Criteria:
Inclusion Criteria:
* written informed consent (by parents, caregiver)
* Healthy term newborns (gestational age: ≥ 37 weeks)
* Birth weight between 2.500 - 4.500 g
* Age at enrolment: \< 28 days of age
* Infant received no other formula since birth
* Parents / Caregivers are able to speak German
Exclusion Criteria:
* Severe acquired or congenital illness
* preterm infants (gestational age \< 37 weeks)
* Birth weight lower than 2.500 g or higher than 4.500 g
* Feeding a cows milk based formula or any other formula prior to inclusion in this study
* Participation in any other clinical study intervention
* Regular intake of supplementary pre- and probiotics by the child and/or breastfeeding mother
* Mothers with diabetes mellitus or mothers suffered from gestational diabetes
* Founded assumption that it will not be possible for parents / caregivers to be compliant with the study protocol
* Breastfed infants: illness of the mother, that may have an influence on the gastrointestinal tract of the child
* Breastfed infants: mother receives or received antibiotics one week before inclusion in this study or during the first study phase
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
27 Days
Study:
NCT01143233
Study Brief:
Protocol Section:
NCT01143233