Clinical Study of Partially Hydrolysed Protein Infant Formula on Trans-epidermal Water Loss (TEWL)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atopic Dermatitis
- Sponsor
- Société des Produits Nestlé (SPN)
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Skin barrier function
- Status
- Completed
- Last Updated
- 10 months ago
Overview
Brief Summary
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).
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Infants 42± 7 days of age at enrolment (date of birth = age 0).
- •Infants who have been born full-term gestational birth (≥ 37 completed weeks of gestation) and having a birth weight ≥ 2.5 kg and ≤ 4.5 kg.
- •Parents /caregivers must agree to follow study procedures and recommended skincare routines, such as avoidance of moisturizers or other skincare products on the primary sites of interest.
- •Parent(s) must have already independently elected before enrolment to formula feed and less than 30% of intake will be from breastmilk.
Exclusion Criteria
- •Known and diagnosed cow's milk protein allergy/intolerance.
- •Infants currently using or have ever used partially hydrolysed protein formulas.
- •Infants who have ever used topical corticosteroids, calcineurin inhibitors and/or any other physician-recommended treatments for skin conditions after birth.
- •Infants who have been introduced to complementary foods.
Outcomes
Primary Outcomes
Skin barrier function
Time Frame: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months)
Change in Trans-epidermal water loss (TEWL)
Secondary Outcomes
- Weight(Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months) - in both randomized groups and until Study Month 15 (age 18 months) in pHF group only)
- Stool consistency(Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months))
- Length(Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months) - in both randomized groups and until Study Month 15 (age 18 months) in pHF group only)
- Head Circumference(Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months) - in both randomized groups and until Study Month 15 (age 18 months) in pHF group only)
- Infant health-related quality of life(Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months) - in both randomized groups and until Study Month 15 (age 18 months) in pHF group only)
- Incidence and severity of Atopic Dermatitis (AD) and other allergic manifestations (CMF group)(aseline (age 42 ± 7 days) to Study Month 4 (age 6 months) - in both randomized groups and until Study Month 15 (age 18 months) in pHF group only)
- Infant gut comfort(Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months))
- Toddler gut comfort(Study Month 9 (age 12 months) and Study Month 15 (age 18 months))
- Formula acceptance and satisfaction(Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months) - in both randomized groups and until Study Month 15 (age 18 months) in pHF group only)
- Safety assessment: Adverse events (AEs)(Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months) - in both randomized groups and until Study Month 15 (age 18 months) in pHF group only)