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

Study Overview
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Brief Summary
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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
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View Section Brief Summary

Official Title
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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

Conditions
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Disturbance of Growth

Intervention / Treatment
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* Other: control formula
* Other: intervention formula 1
* Other: intervention formula 2
* Other: intervention formula 3


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 27 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control formula group<br>infants are fed a commercial, hydrolysed formula during the first 4 month of life, according to protocol | Other: control formula<br>* infants are fed a commercial hydrolyzed formula<br>|
| Experimental: intervention formula 1 group<br>infants are fed hydrolyzed infant formula with different protein content during the first 4 month of life, according to protocol | Other: intervention formula 1<br>* formula has hydrolysed protein and a different protein content<br>|
| Experimental: intervention formula 2 group<br>infants are fed hydrolyzed infant formula with different protein content with pro- and prebiotics during the first 4 month of life, according to protocol | Other: intervention formula 2<br>* formula has hydrolysed protein, different protein content and pro- and prebiotics<br>|
| Experimental: intervention formula 3 group<br>infants are fed hydrolyzed instant formula with different protein content with pro- and prebiotics during the first 4 months of life, according to protocol | Other: intervention formula 3<br>* formula has hydrolysed protein, different protein content and pro- and prebiotics<br>|
| No Intervention: Reference group<br>infants are breast fed | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| average weight gain | The intervention is to assess average weight gain in the first 4 months of life. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| allergic sensitization and symptoms | blood sample to assess allergic predisposition | 12 months | 
| Anthropometric data at age of 4 years | Weight, length and Head circumference measurements at Age of 4 years | 4 years | 
| Body composition (Skin fold) at age of 4 years | Caliper measurement at Age of 4 years | 4 years | 
| Body composition (fat mass, lean body mass) at age of 4 years | bioelectrical impedance Analysis at Age of 4 years | 4 years | 
| Allergic predisposition at age of 4 years by measuring specific IgE in blood | blood sample to allergic predisposition at Age of 4 years | 4 years |