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NCT Number: NCT04763512

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

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).

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Condition Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

35 day–49 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Tonxin Pediatric Clinic Co. Ltd

Shanghai, Shanghai Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intact Cow's Milk Protein Formula

Dietary Supplement

Study product will be provided as powder, reconstituted with water by parents/caregivers according to label instructions, and consumed orally. Study participants will continue this feeding regimen for 4 months.

Partially Hydrolysed Whey Formula

Dietary Supplement

Study product will be provided as powder, reconstituted with water by parents/caregivers according to label instructions, and consumed orally. Study participants will continue this feeding regimen for 16 months.

Primary outcomes

  1. 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

  1. Weight

    Time frame: 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

    Weight in grams and corresponding Z-score according to WHO reference standards and/or local standardized growth charts will be calculated.

  2. Length

    Time frame: 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

    Length in centimeters and corresponding Z-score according to WHO reference standards and/or local standardized growth charts will be calculated.

  3. Head Circumference

    Time frame: 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 in centimeters and corresponding Z-score according to WHO reference standards and/or local standardized growth charts will be calculated.

  4. Infant health-related quality of life

    Time frame: 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

    Assessed through a parent-reported, validated questionnaire called Infant Toddler Quality of Life questionnaire 47-item short-form (ITQOL-SF47). For each concept, item responses are scored, summed, and transformed on a scale from 0 (worst health) to 100 (best health).

  5. Infant health-related quality of life

    Time frame: 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

    Assessed through the Happy Growth Index Questionnaire with each question rated on a Likert scale from strongly disagree to strongly agree.

  6. Incidence and severity of Atopic Dermatitis (AD) and other allergic manifestations (CMF group)

    Time frame: 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

    Incidence will be gathered from standard Adverse Event (AE) reporting. Atopic Dermatitis (AD) will be diagnose based on the Williams diagnostic criteria of International Study of Asthma and Allergies in Childhood (ISAAC). Severity of AD will be assessed using the SCORing Atopic Dermatitis (SCORAD) index, which consists of the extent and intensity of the disorder and subjective symptoms.

  7. Infant gut comfort

    Time frame: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months)

    Using the Infant Gastrointestinal Symptom Questionnaire (IGSQ)-13.

  8. Toddler gut comfort

    Time frame: Study Month 9 (age 12 months) and Study Month 15 (age 18 months)

    Using the Toddler Gut Comfort Questionnaire.

  9. Stool consistency

    Time frame: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months)

    Parents will record for 3 consecutive days after each bowel movement in a 3-Day Stool Diary the stool consistency on a validated 5-point scale from 1-watery to 5-hard.

  10. Formula acceptance and satisfaction

    Time frame: 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

    Formula intake, acceptability and satisfaction recorded using the Milk Intake and Satisfaction Questionnaire.

  11. Safety assessment: Adverse events (AEs)

    Time frame: 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

    Using standard adverse events (AEs) reporting for safety assessment.

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Collaborators

  • Cognizant Technology Solutions AG
  • Medidata Solutions
  • SAS Institute
  • Veeva Systems

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Feb 21, 2021
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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