Clinical Study of Partially Hydrolysed Protein Infant Formula on Trans-epidermal Water Loss (TEWL)

Nestlé

Status: Completed

Conditions: Atopic Dermatitis; Skin Condition

Treatments: Dietary Supplement: Partially Hydrolysed Whey Formula; Dietary Supplement: Intact Cow's Milk Protein Formula

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04763512

20.16.INF

Details and patient eligibility

About

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).

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 35 to 49 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Intact Cow's Milk Protein Formula Group (CMFG)

Experimental group

Description:

All enrolled subjects will be fed Stage 1 CMF libitum for 4 months. Thereafter, they will discontinue study formula and complete the study.

Treatment:

Dietary Supplement: Intact Cow's Milk Protein Formula

Partially Hydrolysed Whey Formula Group (pHFG)

Experimental group

Description:

All enrolled subjects will be fed Stage 1 pHF libitum for 4 months. Thereafter, they will switch to Stage 2 pHF at age 6 months (Study Month 4) and to Stage 3 pHF at age 12 months (Study Month 9) and continue until age 18 months (Study Month 15). Thereafter, they will discontinue study formula and complete the study.

Treatment:

Dietary Supplement: Partially Hydrolysed Whey Formula