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 - Full Text View

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:

MedlinePlus related topics: Infant and Newborn Nutrition

U.S. FDA Resources

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 September 26, 2016

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)