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 (HippHA)

This study is currently recruiting participants.
Verified September 2012 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: September 3, 2012
Last verified: September 2012
  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 proteinhydrolysate with modified protein content is non inferior compared to a standard infant formula based on a proteinhyrolysate in respect to proper growth of healthy, term infants within the first four month of life.


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 monhts ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: April 2010
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: December 2013 (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
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
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: Ingrid Lawnitzak 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: Arnold Pollak, Prof.    +43 1 40400 3232    arnold.pollak@meduniwien.ac.at   
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: Eckard Hamelmann, Prof.    +49 234 509 2611    e.hamelmann@klinikum-bochum.de   
Contact: Annette Meyer    +49 234 5092635    a.meyer@klinikum-bochum.de   
Sub-Investigator: Eckard Hamelmann, 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
  More Information

No publications provided

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: September 3, 2012
Health Authority: Germany: German Institute of Medical Documentation and Information

ClinicalTrials.gov processed this record on April 15, 2014