Low-protein Infant Formula With Partial or Extensive Proteinhydrolysate 4 Year Follow-up

Suitability of an Infant Formula With Reduced Protein Content Based on a Partial Respectively an Extensive Proteinhydrolysate With and Without Pro- and Prebiotics for the Particular Nutritional Use by Infants.-Extension by 4 Year Follow-up

The study is conducted to examine the suitability of partially respectively extensively hydrolyzed low protein infant formulae with and without pro- and prebiotics for healthy, term infants.

Primary hypothesis to be tested is: an infant formula based on a Protein hydrolysate with modified protein content is non inferior compared to a standard infant formula based on a Protein hyrolysate in respect to proper growth of healthy, term infants within the first four month of life.

4-year follow-up (without further Intervention) will focus on body composition and allergic predisposition.

View Section Brief Summary

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