Prevention of Allergic Diseases in Infants

Atopic Diseases Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03489733
• Other study ID #: 508917
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 9, 2018
• Est. completion date: March 2026

Study information

• Verified date: March 2023
• Source: HiPP GmbH & Co. Vertrieb KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1170
• Est. completion date: March 2026
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 56 Days

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Diseases

Intervention

Other:
• Hydrolyzed Formula
Infant formula with extensively hydrolyzed proteins and pre- and probiotics.
• Control formula
Infant formula with intact proteins and pre- and probiotics.

Locations

Country	Name	City	State
Bulgaria	Second specialized obstetric and gynecological hospital for active treatment Sheinovo EAD	Sofia
Czechia	Nemocnice Strakonice, a.s.	Strakonice
Finland	Suomen Terveystalo Oy	Tampere
France	CHU Estaing	Clermont-Ferrand
Germany	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
Italy	Unità Allergologia-Unità Allergologia-	Roma
Poland	Instytut Mikroekologii	Poznan
Portugal	Hospital braga	Braga
Serbia	Clinical Hospital Center "Dr Dragisa Misovic-Dedinje"	Belgrade
Spain	Complejo Hospitalario Universitario de Santiago	Santiago De Compostela

Sponsors (1)

Lead Sponsor	Collaborator
HiPP GmbH & Co. Vertrieb KG

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence of atopic dermatitis	Presence of atopic dermatitis on physical examination	1 year