Atopic Diseases
Conditions
Brief summary
A multi-center, prospective, randomized, controlled, doubleblind intervention clinical Trial is performed to proof the efficiency of hydrolyzed infant formula showing a risk reduction of developing an allergy.
Interventions
OTHERHydrolyzed Formula
Infant formula with extensively hydrolyzed proteins and pre- and probiotics.
OTHERControl formula
Infant formula with intact proteins and pre- and probiotics.
Sponsors
HiPP GmbH & Co. Vertrieb KG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 56 Days
Healthy volunteers
Yes
Inclusion criteria
* Healthy term-born male and female infants (gestational Age ≥37+0, singleton birth) * 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
* Multiple births * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of atopic dermatitis | 1 year | Presence of atopic dermatitis on physical examination |
Countries
Bulgaria, Czechia, Finland, France, Germany, Italy, Poland, Portugal, Serbia, Spain
Contacts
PRINCIPAL_INVESTIGATORKirsten Beyer, Prof Dr med
Charite University, Berlin, Germany
Outcome results
None listed