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This is a single-centre, prospective, randomized, open-label, controlled trial of 200 infants 42±7 days of age. Subjects will be randomized to one of two open label feeding intervention group: * Intact Cow's Milk Protein Formula Group (CMFG) (n = 100) or * Partially Hydrolysed Whey Formula Group (pHFG) (n = 100).
Atopic dermatitis (AD) affects 15 - 30% of children. Approximately 45% of these cases have an onset within the first 6 months of life and 60% develop within the first year (Bieber 2010). Besides environmental factors, the aetiology of AD has been found to be associated with genetic variants involved in skin barrier function defect and inflammation, leading to dry skin with increases in susceptibility to environmental exposures (Bieber 2008). Partially hydrolysed cow's milk (whey) protein infant formula (pHF) has been shown to be effective in prevention of AD, both among at-risk and healthy infants (Exl, Deland et al. 2000, von Berg, Koletzko et al. 2003, Jingrana and Dunjina 2015). However, to date there are no published pediatric data to document the relationship between partially hydrolysed protein formulas and skin barrier function, specifically evaluating the effect of pHF on Trans-epidermal Water Loss (TEWL) among infants. Therefore, this study aims to evaluate the effect on skin barrier function as measured by TEWL and we hypothesize that infants consuming partially hydrolysed starter formula will have lower TEWL when compared infants consuming intact cow's milk protein starter formula.
Age
0 - 0 years
Sex
ALL
Healthy Volunteers
Yes
Shanghai Tonxin Pediatric Clinic Co. Ltd
Shanghai, Shanghai Municipality, China
Start Date
June 6, 2021
Primary Completion Date
September 19, 2023
Completion Date
November 2, 2024
Last Updated
June 27, 2025
200
ACTUAL participants
Intact Cow's Milk Protein Formula
DIETARY_SUPPLEMENT
Partially Hydrolysed Whey Formula
DIETARY_SUPPLEMENT
Lead Sponsor
Société des Produits Nestlé (SPN)
Collaborators
NCT07262983
NCT06389136
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06342713