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Prevention of Allergic Diseases in Infants

NCT03489733 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1226

Last updated 2026-03-09

No results posted yet for this study

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.

Conditions

  • Atopic Diseases

Interventions

OTHER

Hydrolyzed Formula

Infant formula with extensively hydrolyzed proteins and pre- and probiotics.

OTHER

Control formula

Infant formula with intact proteins and pre- and probiotics.

Sponsors & Collaborators

  • HiPP GmbH & Co. Vertrieb KG

    lead INDUSTRY

Principal Investigators

  • Kirsten Beyer, Prof Dr med · Charite University, Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
56 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-09
Primary Completion
2021-03-31
Completion
2025-10-30

Countries

  • Bulgaria
  • Czechia
  • Finland
  • France
  • Germany
  • Italy
  • Poland
  • Portugal
  • Serbia
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03489733 on ClinicalTrials.gov