Prevention of Allergic Diseases in Infants

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

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.

Study Overview

• Status: Completed
• Conditions: Atopic Diseases
• Intervention / Treatment: Other: Hydrolyzed Formula; Other: Control formula

• Study Type: Interventional
• Enrollment (Actual): 1226
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria
    • Second specialized obstetric and gynecological hospital for active treatment Sheinovo EAD
• Czechia
  • Strakonice, Czechia
    • Nemocnice Strakonice, a.s.
• Finland
  • Tampere, Finland
    • Suomen Terveystalo Oy
• France
  • Clermont-Ferrand, France
    • Chu Estaing
• Germany
  • Berlin, Germany
    • Charité Universitätsmedizin Berlin
  • Bochum, Germany
    • Klinik für Kinder- und Jugendmedizin der Ruhruniversität Bochum im St. Josef Hospital
  • Frankfurt, Germany
    • Studienambulanz der pädiatrische Pneumologie und AllergologieKlinik für Kinder- und Jugendmedizin (KKJM)
  • Hamm, Germany
    • Klinik für Kinder und Jugendmedizin
  • Wesel, Germany
    • Klinik für Kinder- und Jugendmedizin Marienhospital gGmbH Wesel
• Italy
  • Roma, Italy
    • Unità Allergologia-Unità Allergologia-
• Poland
  • Poznan, Poland
    • Instytut Mikroekologii
• Portugal
  • Braga, Portugal
    • Hospital braga
• Serbia
  • Belgrade, Serbia
    • Clinical Hospital Center "Dr Dragisa Misovic-Dedinje"
• Spain
  • Santiago de Compostela, Spain
    • Complejo Hospitalario Universitario de Santiago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 month (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: HiPP GmbH & Co. Vertrieb KG
• Investigators: Principal Investigator: Kirsten Beyer, Prof Dr med, Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2018
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): October 30, 2025

Study Registration Dates

• First Submitted: March 26, 2018
• First Submitted That Met QC Criteria: April 4, 2018
• First Posted (Actual): April 5, 2018

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 508917

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No