Effect of Partially Hydrolyzed Formula With Synbiotics on Skin Barrier Function

Launched by SOCIÉTÉ DES PRODUITS NESTLÉ (SPN) · Apr 16, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how a special baby formula, which includes partially hydrolyzed proteins and beneficial bacteria (called synbiotics), can help improve skin barrier function in infants who are at risk of developing allergies, particularly atopic dermatitis (a type of skin condition). The goal is to see if this formula can stop early allergic reactions in babies and to check its safety and effectiveness.

To participate in this study, infants must be between 1 and 14 days old, born at a healthy weight (between 2.5 kg and 4.5 kg), and come from families with a history of allergies. Parents or guardians will need to give their permission for the baby to join the trial and understand the study details. Babies can either be exclusively breastfed or mostly formula-fed, and the study is open to all genders. If selected, families can expect to follow specific guidelines throughout the trial, helping researchers learn more about how this formula could help infants at risk of allergies.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Written informed consent has been obtained from at least one parent or legally acceptable representative (LAR), if applicable
• • 2. Infant gestational age ≥ 37 completed weeks
• • 3. Infant birth weight of ≥ 2.5 kg and ≤ 4.5 kg
• • 4. Infant postnatal age ≤ 14 days (date of birth = day 0) at enrollment
• • 5. Infant from singleton birth or infant from multiple births may if all birth siblings are enrolled.
• • 6. At least one biological parent or sibling has (or had) a medically diagnosed history of allergy, based on response to a simple screening questionnaire
• • 7. 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.
• • 8. Parents/LAR must be able to provide evidence of parental authority and identity.
• • 9. 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 Criteria:
• • 1. Infectious, metabolic, congenital, genetic, gastrointestinal illness or any other condition (e.g., gastrointestinal surgery) that could impact oral feeding, growth or study outcomes.
• • 2. 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.
• • 3. Infant has already been diagnosed with allergy by a physician, including AD and/or cow's milk allergy.
• • 4. Infant is currently participating or has previously participated in another clinical trial prior to enrollment.
• • 5. Infant's parents or LARs have not reached legal age of majority (18 years).