Prevention of Allergic Diseases in Infants

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Low Protein, Extensively Hydrolyzed Infant Formula on Allergy Prevention in At-risk Infants up to 1 Year of Age: a Randomized, Double-blind, Controlled Intervention Study and the Long-term Effect on Allergy Prevention of Early Nutrition Given in the First 120 Days of Life in At-risk Infants Until the Child is 6 Years of Age

Conditions
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Atopic Diseases

Intervention / Treatment
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* Other: Hydrolyzed Formula
* Other: Control formula


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 56 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Infant Formula with hydrolyzed protein and breast milk until at least 120 days of life | Other: Hydrolyzed Formula<br>* Infant formula with extensively hydrolyzed proteins and pre- and probiotics.<br>|
| Experimental: Control Group<br>Infant Formula with intact protein and breast milk until at least 120 days of life | Other: Control formula<br>* Infant formula with intact proteins and pre- and probiotics.<br>|
| No Intervention: Breast Fed Group<br>Exclusively breast ilk until at least 120 days of life | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of atopic dermatitis | Presence of atopic dermatitis on physical examination | 1 year |