Effect of Partially Hydrolyzed Formula With Synbiotics on Skin Barrier Function (NCT06943469) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Partially Hydrolyzed Formula With Synbiotics on Skin Barrier Function
Belgium, France400 participantsStarted 2025-04-10
Plain-language summary
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.
Who can participate
Age range1 Day – 14 Days
SexALL
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Inclusion criteria
✓. 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
✓. Infant from singleton birth or infant from multiple births may if all birth siblings are enrolled.
✓. At least one biological parent or sibling has (or had) a medically diagnosed history of allergy, based on response to a simple screening questionnaire
✓. a. For the breastfed reference group only: infant is exclusively breastfed since birth with no intake of formula, and their parent(s) have the intention to continue exclusive breastfeeding until at least 4 months of age.
✓. Parents/LAR must be able to provide evidence of parental authority and identity.
Exclusion criteria
✕. 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.