Skip to main content
OpenTrials
Completed

NCT Number: NCT03489733

Prevention of Allergic Diseases in Infants

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atopic Diseases

Age range

Up to 56 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Second specialized obstetric and gynecological hospital for active treatment Sheinovo EAD, Sofia, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hydrolyzed Formula

Other

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

Control Formula

Other

Infant formula with intact proteins and pre- and probiotics.

Primary outcomes

  1. Cumulative incidence of atopic dermatitis

    Time frame: 1 year

    Presence of atopic dermatitis on physical examination

Sponsors and collaborators

Lead sponsor

HiPP GmbH & Co. Vertrieb KG

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2025
First posted
Apr 5, 2018
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.