Status:
RECRUITING
Effect of Partially Hydrolyzed Formula With Synbiotics on Skin Barrier Function
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Atopic Dermatitis (AD)
Eligibility:
All Genders
1-14 years
Phase:
NA
Brief 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 ris...
Eligibility Criteria
Inclusion
- 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.
- or b. For the randomized formula-fed groups only: infant is exclusively or predominantly formula-fed in the 24 hours prior to enrollment, with formula feeding representing at least 75% of total daily feeds. The decision to introduce formula feeding was independently made by the parents before enrollment.
- Parents/LAR must be able to provide evidence of parental authority and identity.
- Infant's parent(s)/LAR must understand the informed consent form and other study documents and are willing and able to fulfill the requirements of the study protocol.
Exclusion
- 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.
- Infant's parents or LARs have not reached legal age of majority (18 years).
Key Trial Info
Start Date :
April 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06943469
Start Date
April 10 2025
End Date
November 1 2028
Last Update
December 12 2025
Active Locations (23)
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1
AZ Sint-Jan Brugge-Oostende AV - Campus Sint-Jan
Bruges, Belgium
2
Universitair Ziekenhuis Brussel - Kinderziekenhuis
Brussels, Belgium
3
Clinique Ste Elisabeth
Namur, Belgium
4
CHU Amiens Picardie
Amiens, France