Disturbance of Growth
Conditions
Brief summary
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.
Detailed description
View Section Brief Summary
Interventions
OTHERcontrol formula
infants are fed a commercial hydrolyzed formula
formula has hydrolysed protein and a different protein content
formula has hydrolysed protein, different protein content and pro- and prebiotics
OTHERintervention formula 3
formula has hydrolysed protein, different protein content and pro- and prebiotics
Sponsors
Charite University, Berlin, Germany
HiPP GmbH & Co. Vertrieb KG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Days to 27 Days
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| average weight gain | 4 months | The intervention is to assess average weight gain in the first 4 months of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| allergic sensitization and symptoms | 12 months | blood sample to assess allergic predisposition |
| Anthropometric data at age of 4 years | 4 years | Weight, length and Head circumference measurements at Age of 4 years |
| Body composition (Skin fold) at age of 4 years | 4 years | Caliper measurement at Age of 4 years |
| Body composition (fat mass, lean body mass) at age of 4 years | 4 years | bioelectrical impedance Analysis at Age of 4 years |
| Allergic predisposition at age of 4 years by measuring specific IgE in blood | 4 years | blood sample to allergic predisposition at Age of 4 years |
Countries
Austria, Germany, Serbia
Outcome results
None listed