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:
HiPP GmbH & Co.
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
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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 May 19, 2013