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Prevention of Allergic Diseases in Infants

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ClinicalTrials.gov Identifier: NCT03489733
Recruitment Status : Recruiting
First Posted : April 5, 2018
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Atopic Diseases Other: Hydrolyzed Formula Other: Control formula Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 9, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Group Other: Hydrolyzed Formula
Infant formula with extensively hydrolyzed proteins and pre- and probiotics.

Experimental: Control Group Other: Control formula
Infant formula with intact proteins and pre- and probiotics.

No Intervention: Breast Fed Group



Primary Outcome Measures :
  1. Cumulative incidence of atopic dermatitis [ Time Frame: 1 year ]


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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy term-born male and female infants (gestational Age ≥37+0, twins allowed)
  • Birth weight ≥ 2500 g and ≤ 4500 g
  • Age at enrollment: ≤ 28 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:

  • Triplets or quadruplets
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03489733


Contacts
Contact: Bianca Arendt, Dr. +4984417571047 Bianca.Arendt@hipp.de

Locations
Finland
Turku University Central Hospital Recruiting
Turku, Finland, 20521
Contact: Ove Mickelsson, Dr         
Sponsors and Collaborators
HiPP GmbH & Co. Vertrieb KG
Investigators
Principal Investigator: Kirsten Beyer, Prof. Dr. med. Charite University, Berlin, Germany

Responsible Party: HiPP GmbH & Co. Vertrieb KG
ClinicalTrials.gov Identifier: NCT03489733     History of Changes
Other Study ID Numbers: 508917
First Posted: April 5, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No