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Prevention of Allergic Diseases in Infants

Sponsor
HiPP GmbH & Co. Vertrieb KG (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03489733
Collaborator
(none)
1,170
Enrollment
14
Locations
3
Arms
91.7
Anticipated Duration (Months)
83.6
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Hydrolyzed Formula
  • Other: Control formula
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1170 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Jul 9, 2018
Actual Primary Completion Date :
Mar 31, 2021
Anticipated Study Completion Date :
Mar 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Group

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

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

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

Other: Control formula
Infant formula with intact proteins and pre- and probiotics.
No Intervention: Breast Fed Group

Exclusively breast ilk until at least 120 days of life

Outcome Measures

Primary Outcome Measures

  1. Cumulative incidence of atopic dermatitis [1 year]

    Presence of atopic dermatitis on physical examination

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 56 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Second specialized obstetric and gynecological hospital for active treatment Sheinovo EAD Sofia Bulgaria
2 Nemocnice Strakonice, a.s. Strakonice Czechia
3 Suomen Terveystalo Oy Tampere Finland
4 CHU Estaing Clermont-Ferrand France
5 Charité Universitätsmedizin Berlin Berlin Germany
6 Klinik für Kinder- und Jugendmedizin der Ruhruniversität Bochum im St. Josef Hospital Bochum Germany
7 Studienambulanz der pädiatrische Pneumologie und AllergologieKlinik für Kinder- und Jugendmedizin (KKJM) Frankfurt Germany
8 Klinik für Kinder und Jugendmedizin Hamm Germany
9 Klinik für Kinder- und Jugendmedizin Marienhospital gGmbH Wesel Wesel Germany
10 Unità Allergologia-Unità Allergologia- Roma Italy
11 Instytut Mikroekologii Poznań Poland
12 Hospital braga Braga Portugal
13 Clinical Hospital Center "Dr Dragisa Misovic-Dedinje" Belgrade Serbia
14 Complejo Hospitalario Universitario de Santiago Santiago De Compostela Spain

Sponsors and Collaborators

  • HiPP GmbH & Co. Vertrieb KG

Investigators

  • Principal Investigator: Kirsten Beyer, Prof Dr med, Charite University, Berlin, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
HiPP GmbH & Co. Vertrieb KG
ClinicalTrials.gov Identifier:
NCT03489733
Other Study ID Numbers:
  • 508917
First Posted:
Apr 5, 2018
Last Update Posted:
Aug 25, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 25, 2021