Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
1170 participants
INTERVENTIONAL
2018-07-09
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Intervention Group
Infant Formula with hydrolyzed protein and breast milk until at least 120 days of life
Hydrolyzed Formula
Infant formula with extensively hydrolyzed proteins and pre- and probiotics.
Control Group
Infant Formula with intact protein and breast milk until at least 120 days of life
Control formula
Infant formula with intact proteins and pre- and probiotics.
Breast Fed Group
Exclusively breast ilk until at least 120 days of life
No interventions assigned to this group
Interventions
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Hydrolyzed Formula
Infant formula with extensively hydrolyzed proteins and pre- and probiotics.
Control formula
Infant formula with intact proteins and pre- and probiotics.
Eligibility Criteria
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Inclusion Criteria
* Birth weight ≥ 2500 g and ≤ 4500 g
* Age at enrollment: ≤ 56 days of life
* At risk of developing atopic diseases
* Free of atopy symptoms at Screening and at any time before randomization
* Feeding regimen at any time before Screening (V1) and Baseline (V2, infants who will receive Interventional Product (IP)): no infant formula feeding and solid foods allowed (in order to exclude prior sensitization) except amino acid formula (e.g. Neocate Infant), maltodextrin or glucose solution/gel; breastfeeding allowed
* Subject's parents/caregivers willing to comply with the feeding regimen during the intervention period. Subject's parents/caregivers will decide which feeding regimen will be used (IP or breast milk):
* IP regimen (intervention or control group): only IP and breast milk until at least 120 days of life
* breastfeeding regimen (reference group): exclusively breast milk until at least 120 days of life.
* No other infant formulas or solid foods are allowed.
* Written informed consent.
Exclusion Criteria
* Premature delivery (gestational age ≤ 36+6)
* Neonatal illnesses that might have an impact on allergy development (based on Investigator's decision)
* Significant congenital abnormalities
* Participation in another clinical study with an IP or study method that would influence the outcome of this study
* Reason to presume that the subject's parents/caregivers are unable to meet study plan requirements.
56 Days
ALL
Yes
Sponsors
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HiPP GmbH & Co. Vertrieb KG
INDUSTRY
Responsible Party
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Principal Investigators
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Kirsten Beyer, Prof Dr med
Role: PRINCIPAL_INVESTIGATOR
Charite University, Berlin, Germany
Locations
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Second specialized obstetric and gynecological hospital for active treatment Sheinovo EAD
Sofia, , Bulgaria
Nemocnice Strakonice, a.s.
Strakonice, , Czechia
Suomen Terveystalo Oy
Tampere, , Finland
CHU Estaing
Clermont-Ferrand, , France
Charité Universitätsmedizin Berlin
Berlin, , Germany
Klinik für Kinder- und Jugendmedizin der Ruhruniversität Bochum im St. Josef Hospital
Bochum, , Germany
Studienambulanz der pädiatrische Pneumologie und AllergologieKlinik für Kinder- und Jugendmedizin (KKJM)
Frankfurt, , Germany
Klinik für Kinder und Jugendmedizin
Hamm, , Germany
Klinik für Kinder- und Jugendmedizin Marienhospital gGmbH Wesel
Wesel, , Germany
Unità Allergologia-Unità Allergologia-
Roma, , Italy
Instytut Mikroekologii
Poznan, , Poland
Hospital braga
Braga, , Portugal
Clinical Hospital Center "Dr Dragisa Misovic-Dedinje"
Belgrade, , Serbia
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, , Spain
Countries
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Other Identifiers
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508917
Identifier Type: -
Identifier Source: org_study_id
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