Clinical trial NCT04763512: Clinical Study of Partially Hydrolysed Protein Infant Formula on Trans-epidermal Water Loss (TEWL)
Official title: Clinical Study of Partially Hydrolysed Protein Infant Formula on Trans-epidermal Water Loss (TEWL)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atopic Dermatitis
Skin Condition
Keywords: atopic dermatitis development
trans-epidermal water loss
allergy
growth patterns
quality of life
gut comfort
partially hydrolysed whey
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
Collaborators: name: Medidata Solutions
name: SAS Institute
name: Veeva Systems
name: Cognizant Technology Solutions AG
First posted: 2021-02-21
Enrollment: 200
Sex: ALL
Minimum age (years): 35
Maximum age (years): 49
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Skin barrier function
timeFrame: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months)
Secondary outcomes:
measure: Weight
timeFrame: 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
measure: Length
timeFrame: 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
measure: Head Circumference
timeFrame: 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
measure: Infant health-related quality of life
timeFrame: 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
measure: Infant health-related quality of life
timeFrame: 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
measure: Incidence and severity of Atopic Dermatitis (AD) and other allergic manifestations (CMF group)
timeFrame: 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
measure: Infant gut comfort
timeFrame: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months)
measure: Toddler gut comfort
timeFrame: Study Month 9 (age 12 months) and Study Month 15 (age 18 months)
measure: Stool consistency
timeFrame: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months)
measure: Formula acceptance and satisfaction
timeFrame: 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
measure: Safety assessment: Adverse events (AEs)
timeFrame: 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
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tonxin Pediatric Clinic Co. Ltd
state: Shanghai
Study officials:
affiliation: Shanghai Tonxin Pediatric Clinic Co. Ltd
name: Jie Shao, Dr.
role: PRINCIPAL_INVESTIGATOR
References: