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

HiPP GmbH & Co. Vertrieb KG5 sites in 3 countries503 target enrollmentApril 2010

ConditionsDisturbance of Growth

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Disturbance of Growth
Sponsor: HiPP GmbH & Co. Vertrieb KG
Enrollment: 503
Locations: 5
Primary Endpoint: average weight gain
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

April 2010

End Date

August 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

HiPP GmbH & Co. Vertrieb KG

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

average weight gain

Time Frame: 4 months

The intervention is to assess average weight gain in the first 4 months of life.

Secondary Outcomes

Anthropometric data at age of 4 years(4 years)
Body composition (Skin fold) at age of 4 years(4 years)
Body composition (fat mass, lean body mass) at age of 4 years(4 years)
allergic sensitization and symptoms(12 months)
Allergic predisposition at age of 4 years by measuring specific IgE in blood(4 years)