Prevention of Allergic Diseases in Infants

Not Applicable

Active, not recruiting

• Conditions: Atopic Diseases

• Registration Number: NCT03489733
• Lead Sponsor: HiPP GmbH & Co. Vertrieb KG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-26
• Study First Submitted QC: 2018-04-04
• Study First Posted: 2018-04-05
• Study Start: 2018-07-09
• Primary Completion: 2021-03-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-31
• Last Update Posted: 2023-04-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1170

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cumulative incidence of atopic dermatitis	1 year	Presence of atopic dermatitis on physical examination

Trial Locations

Locations (14)

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

Nemocnice Strakonice, a.s.; 🇨🇿 Strakonice, Czechia

Suomen Terveystalo Oy; 🇫🇮 Tampere, Finland

CHU Estaing; 🇫🇷 Clermont-Ferrand, France

Charité Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Klinik für Kinder- und Jugendmedizin der Ruhruniversität Bochum im St. Josef Hospital; 🇩🇪 Bochum, Germany

Studienambulanz der pädiatrische Pneumologie und AllergologieKlinik für Kinder- und Jugendmedizin (KKJM); 🇩🇪 Frankfurt, Germany

Klinik für Kinder und Jugendmedizin; 🇩🇪 Hamm, Germany

Klinik für Kinder- und Jugendmedizin Marienhospital gGmbH Wesel; 🇩🇪 Wesel, Germany

Unità Allergologia-Unità Allergologia-; 🇮🇹 Roma, Italy

Scroll for more (4 remaining)