NCT03489733

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,226

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
10 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 5, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

July 9, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

March 9, 2026

Status Verified

October 1, 2025

Enrollment Period

2.7 years

First QC Date

March 26, 2018

Last Update Submit

March 6, 2026

Conditions

Atopic Diseases

Outcome Measures

Primary Outcomes (1)

  • Cumulative incidence of atopic dermatitis

    Presence of atopic dermatitis on physical examination

    1 year

Study Arms (3)

Intervention Group

EXPERIMENTAL

Infant Formula with hydrolyzed protein and breast milk until at least 120 days of life

Other: Hydrolyzed Formula

Control Group

EXPERIMENTAL

Infant Formula with intact protein and breast milk until at least 120 days of life

Other: Control formula

Breast Fed Group

NO INTERVENTION

Exclusively breast ilk until at least 120 days of life

Interventions

Hydrolyzed FormulaOTHER

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

Intervention Group
Control formulaOTHER

Infant formula with intact proteins and pre- and probiotics.

Control Group

Eligibility Criteria

AgeUp to 56 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Second specialized obstetric and gynecological hospital for active treatment Sheinovo EAD

Sofia, Bulgaria

Location

Nemocnice Strakonice, a.s.

Strakonice, Czechia

Location

Suomen Terveystalo Oy

Tampere, Finland

Location

CHU Estaing

Clermont-Ferrand, France

Location

Charité Universitätsmedizin Berlin

Berlin, Germany

Location

Klinik für Kinder- und Jugendmedizin der Ruhruniversität Bochum im St. Josef Hospital

Bochum, Germany

Location

Studienambulanz der pädiatrische Pneumologie und AllergologieKlinik für Kinder- und Jugendmedizin (KKJM)

Frankfurt, Germany

Location

Klinik für Kinder und Jugendmedizin

Hamm, Germany

Location

Klinik für Kinder- und Jugendmedizin Marienhospital gGmbH Wesel

Wesel, Germany

Location

Unità Allergologia-Unità Allergologia-

Roma, Italy

Location

Instytut Mikroekologii

Poznan, Poland

Location

Hospital braga

Braga, Portugal

Location

Clinical Hospital Center "Dr Dragisa Misovic-Dedinje"

Belgrade, Serbia

Location

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, Spain

Location

Study Officials

  • Kirsten Beyer, Prof Dr med

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2018

First Posted

April 5, 2018

Study Start

July 9, 2018

Primary Completion

March 31, 2021

Study Completion

October 30, 2025

Last Updated

March 9, 2026

Record last verified: 2025-10

Locations

IT(1)FR(1)CZ(1)PL(1)FI(1)ES(1)PT(1)BU(1)DE(5)SE(1)