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Suitability of an Infant Formula With Reduced Protein Content Based on a Partial Respectively Extensive Proteinhydrolysate With and Without Pro- and Prebiotics for the Particular Nutritional Use by Infants -Extension by 4 Year Follow-up (HippHA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by HiPP GmbH & Co.
Sponsor:
Collaborator:
Charite University, Berlin, Germany
Information provided by (Responsible Party):
HiPP GmbH & Co.
ClinicalTrials.gov Identifier:
NCT01143233
First received: June 11, 2010
Last updated: April 20, 2016
Last verified: April 2016
  Purpose

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.


Condition Intervention
Disturbance of Growth
Other: control formula
Other: intervention formula 1
Other: intervention formula 2
Other: intervention formula 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by HiPP GmbH & Co.:

Primary Outcome Measures:
  • average weight gain [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    The intervention is to assess average weight gain in the first 4 months of life.


Secondary Outcome Measures:
  • allergic sensitization and symptoms [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    blood sample to assess allergic predisposition

  • Anthropometric data at age of 4 years [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    Weight, length and Head circumference measurements at Age of 4 years

  • Body composition (Skin fold) at age of 4 years [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    Caliper measurement at Age of 4 years

  • Body composition (fat mass, lean body mass) at age of 4 years [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    bioelectrical impedance Analysis at Age of 4 years

  • Allergic predisposition at age of 4 years by measuring specific IgE in blood [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    blood sample to allergic predisposition at Age of 4 years


Estimated Enrollment: 503
Study Start Date: April 2010
Estimated Study Completion Date: August 2017
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: control formula group
infants are fed a commercial, hydrolysed formula during the first 4 month of life, according to protocol
Other: control formula
infants are fed a commercial hydrolyzed formula
Experimental: intervention formula 1 group
infants are fed hydrolyzed infant formula with different protein content during the first 4 month of life, according to protocol
Other: intervention formula 1
formula has hydrolysed protein and a different protein content
Experimental: 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
Other: intervention formula 2
formula has hydrolysed protein, different protein content and pro- and prebiotics
Experimental: 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
Other: intervention formula 3
formula has hydrolysed protein, different protein content and pro- and prebiotics
No Intervention: Reference group
infants are breast fed

Detailed Description:
View Section Brief Summary
  Eligibility

Ages Eligible for Study:   up to 27 Days   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01143233

Contacts
Contact: Bellach Johanna 0049 30 450 566 428 kinder-allergiestudien@charite.de
Contact: Susanne Paschke-Goossens 0049 30 450 566 438 kinder-allergiestudien@charite.de

Locations
Austria
Universitätsklinik für Kinder- und Jugendheilkunde, Abt. Neonatologie, päd. Intensivmedizin und Neuropädiatrie Recruiting
Wien, Austria, 1090
Contact: Susanne Greber-Platzer, Prof.         
Contact: Nadja Haiden, Ass. Prof. PD    +43 1 40400 3232    nadja.haiden@meduniwien.ac.at   
Sub-Investigator: Arnold Pollak, Prof.         
Germany
University Hospital Rostock Recruiting
Rostock, Mecklenburg-Vorpommern, Germany, 18059
Contact: Dirk Olbertz, Dr.    +49 381 4401 5501    dirkolbertz@kliniksuedrostock.de   
Sub-Investigator: Volker Schmidt, Dr.         
Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum Recruiting
Bochum, Nordrhein-Westfalen, Germany, 44791
Contact: Uwe Schauer, Prof.    +49 234 509 2611    uwe.schauer@rub.de   
Contact: Sandra Böger    +49 234 5092809    s.boeger@klinikum-bochum.de   
Sub-Investigator: Uwe Schauer, Prof.         
Charité - Universitätsmedizin. Campus Virchow-Klinikum. Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunologie Recruiting
Berlin, Germany, 13353
Contact: Ulrich Wahn, Prof.    0049 30 450 559 852    ulrich.wahn@charite.de   
Principal Investigator: Ulrich Wahn, Prof.         
Serbia
KBC "Dr Dragiša Mišović Dedinje" Not yet recruiting
Belgrade, Serbia, 11000
Contact: Milicia Vusurovic, Dr    +381 11 36 30 700    milica.vusurovic@gmail.com   
Contact: Branka Trisic, Dr    +381 11 3612944    hipp@tehnicom.net   
Sub-Investigator: Milica Vusurovic, Dr         
Sponsors and Collaborators
HiPP GmbH & Co.
Charite University, Berlin, Germany
Investigators
Principal Investigator: Ulrich Wahn, Prof. Charité - Universitätsmedizin. Campus Virchow-Klinikum. Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunologie
Principal Investigator: Kirsten Beyer, Prof Charité - Universitätsmedizin. Campus Virchow-Klinikum. Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunologie
  More Information

Responsible Party: HiPP GmbH & Co.
ClinicalTrials.gov Identifier: NCT01143233     History of Changes
Other Study ID Numbers: Hipp2010 
Study First Received: June 11, 2010
Last Updated: April 20, 2016
Health Authority: Germany: German Institute of Medical Documentation and Information

ClinicalTrials.gov processed this record on December 09, 2016