Low-protein Infant Formula With Partial or Extensive Proteinhydrolysate 4 Year Follow-up
NCT ID: NCT01143233
Last Updated: 2017-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
503 participants
INTERVENTIONAL
2010-04-30
2017-08-31
Brief Summary
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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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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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control formula group
infants are fed a commercial, hydrolysed formula during the first 4 month of life, according to protocol
control formula
infants are fed a commercial hydrolyzed formula
intervention formula 1 group
infants are fed hydrolyzed infant formula with different protein content during the first 4 month of life, according to protocol
intervention formula 1
formula has hydrolysed protein and a different protein content
intervention formula 2 group
infants are fed hydrolyzed infant formula with different protein content with pro- and prebiotics during the first 4 month of life, according to protocol
intervention formula 2
formula has hydrolysed protein, different protein content and pro- and prebiotics
intervention formula 3 group
infants are fed hydrolyzed instant formula with different protein content with pro- and prebiotics during the first 4 months of life, according to protocol
intervention formula 3
formula has hydrolysed protein, different protein content and pro- and prebiotics
Reference group
infants are breast fed
No interventions assigned to this group
Interventions
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control formula
infants are fed a commercial hydrolyzed formula
intervention formula 1
formula has hydrolysed protein and a different protein content
intervention formula 2
formula has hydrolysed protein, different protein content and pro- and prebiotics
intervention formula 3
formula has hydrolysed protein, different protein content and pro- and prebiotics
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Day
27 Days
ALL
Yes
Sponsors
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Charite University, Berlin, Germany
OTHER
HiPP GmbH & Co. Vertrieb KG
INDUSTRY
Responsible Party
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Principal Investigators
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Ulrich Wahn, Prof.
Role: PRINCIPAL_INVESTIGATOR
Charité - Universitätsmedizin. Campus Virchow-Klinikum. Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunologie
Kirsten Beyer, Prof
Role: PRINCIPAL_INVESTIGATOR
Charité - Universitätsmedizin. Campus Virchow-Klinikum. Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunologie
Locations
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Universitätsklinik für Kinder- und Jugendheilkunde, Abt. Neonatologie, päd. Intensivmedizin und Neuropädiatrie
Vienna, , Austria
University Hospital Rostock
Rostock, Mecklenburg-Vorpommern, Germany
Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum
Bochum, North Rhine-Westphalia, Germany
Charité - Universitätsmedizin. Campus Virchow-Klinikum. Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunologie
Berlin, , Germany
KBC "Dr Dragiša Mišović Dedinje"
Belgrade, , Serbia
Countries
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References
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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.
Other Identifiers
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Hipp2010
Identifier Type: -
Identifier Source: org_study_id