Prevention of Allergic Diseases in Infants

HiPP

Status: Active, not recruiting

Conditions: Atopic Diseases

Treatments: Other: Control formula; Other: Hydrolyzed Formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT03489733

508917

Details and patient eligibility

About

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.

Enrollment: 1,170 estimated patients

Sex: All

Ages: Under 56 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,170 participants in 3 patient groups

Intervention Group

Experimental group

Description:

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

Treatment:

Other: Hydrolyzed Formula

Control Group

Experimental group

Description:

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

Treatment:

Other: Control formula

Breast Fed Group

No Intervention group

Description:

Exclusively breast ilk until at least 120 days of life