Clinical trial NCT01143233: Low-protein Infant Formula With Partial or Extensive Proteinhydrolysate 4 Year Follow-up
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disturbance of Growth
Lead sponsor: HiPP GmbH & Co. Vertrieb KG
Sponsor class: INDUSTRY
Collaborators: name: Charite University, Berlin, Germany
First posted: 2010-06-14
Enrollment: 503
Sex: ALL
Minimum age (years): 1
Maximum age (years): 27
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: average weight gain
timeFrame: 4 months
Secondary outcomes:
measure: allergic sensitization and symptoms
timeFrame: 12 months
measure: Anthropometric data at age of 4 years
timeFrame: 4 years
measure: Body composition (Skin fold) at age of 4 years
timeFrame: 4 years
measure: Body composition (fat mass, lean body mass) at age of 4 years
timeFrame: 4 years
measure: Allergic predisposition at age of 4 years by measuring specific IgE in blood
timeFrame: 4 years
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Universitätsklinik für Kinder- und Jugendheilkunde, Abt. Neonatologie, päd. Intensivmedizin und Neuropädiatrie
city: Rostock
country: Germany
facility: University Hospital Rostock
state: Mecklenburg-Vorpommern
city: Bochum
country: Germany
facility: Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin. Campus Virchow-Klinikum. Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunologie
city: Belgrade
country: Serbia
facility: KBC "Dr Dragiša Mišović Dedinje"
Study officials:
affiliation: Charité - Universitätsmedizin. Campus Virchow-Klinikum. Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunologie
name: Ulrich Wahn, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Charité - Universitätsmedizin. Campus Virchow-Klinikum. Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunologie
name: Kirsten Beyer, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ahrens B, Hellmuth C, Haiden N, Olbertz D, Hamelmann E, Vusurovic M, Fleddermann M, Roehle R, Knoll A, Koletzko B, Wahn U, Beyer K. Hydrolyzed Formula With Reduced Protein Content Supports Adequate Growth: A Randomized Controlled Noninferiority Trial. J Pediatr Gastroenterol Nutr. 2018 May;66(5):822-830. doi: 10.1097/MPG.0000000000001853.