Effect of Partially Hydrolyzed Formula With Synbiotics on Skin Barrier Function

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-14
SponsorSociété des Produits Nestlé (SPN)

About this trial

The main purpose of this study is to assess the efficacy of a partially hydrolyzed formula with synbiotics in halting one of the first steps of the allergic march (atopic dermatitis) in infants at risk of allergy. Other efficacy and safety parameters will be assessed as well.

Eligibility criteria

Qualifiers

Written informed consent has been obtained from at least one parent or legally acceptable representative (LAR), if applicable

Infant gestational age ≥ 37 completed weeks

Infant birth weight of ≥ 2.5 kg and ≤ 4.5 kg

Infant postnatal age ≤ 14 days (date of birth = day 0) at enrollment

Disqualifiers

Infectious, metabolic, congenital, genetic, gastrointestinal illness or any other condition (e.g., gastrointestinal surgery) that could impact oral feeding, growth or study outcomes.

Infants with special dietary needs other than standard infant formula (e.g., extensively hydrolyzed formula, amino acid formula, special formula for metabolic diseases) or requiring tube feeding.

Infant has already been diagnosed with allergy by a physician, including AD and/or cow's milk allergy.

Infant is currently participating or has previously participated in another clinical trial prior to enrollment.

Trial design

Treatments tested in this trial

  • Test formula
  • Control formula

Treatment groups

400 Participants
are divided into 3 treatment groups