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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 (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
History of Changes

June 11, 2010
September 3, 2012
April 2010
December 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01143233 on ClinicalTrials.gov Archive Site
allergic sensitization and symptoms [ Time Frame: 12 monhts ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
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.

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.

View Section Brief Summary
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Disturbance of Growth
  • Other: control formula
    infants are fed a commercial hydrolyzed formula
  • Other: intervention formula 1
    formula has hydrolysed protein and a different protein content
  • Other: intervention formula 2
    formula has hydrolysed protein, different protein content and pro- and prebiotics
  • Other: intervention formula 3
    formula has hydrolysed protein, different protein content and pro- and prebiotics
  • Active Comparator: control formula group
    infants are fed a commercial, hydrolysed formula during the first 4 month of life, according to protocol
    Intervention: Other: control 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
    Intervention: Other: intervention formula 1
  • 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
    Intervention: Other: intervention formula 2
  • 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
    Intervention: Other: intervention formula 3
  • No Intervention: Reference group
    infants are breast fed
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
August 2015
December 2013   (final data collection date for primary outcome measure)

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
Both
up to 27 Days
Yes
Contact: Bellach Johanna 0049 30 450 566 428 kinder-allergiestudien@charite.de
Contact: Ingrid Lawnitzak 0049 30 450 566 438 kinder-allergiestudien@charite.de
Austria,   Germany,   Serbia
 
NCT01143233
Hipp2010
Yes
HiPP GmbH & Co.
HiPP GmbH & Co.
Charite University, Berlin, Germany
Principal Investigator: Ulrich Wahn, Prof. Charité - Universitätsmedizin. Campus Virchow-Klinikum. Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunologie
HiPP GmbH & Co.
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP