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

March 22, 2023 updated by: Société des Produits Nestlé (SPN)

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Tonxin Pediatric Clinic Co. Ltd
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 1 month (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intact Cow's Milk Protein Formula Group (CMFG)
All enrolled subjects will be fed Stage 1 CMF libitum for 4 months. Thereafter, they will discontinue study formula and complete the study.
Dietary supplement: Intact Cow's Milk Protein Formula
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.
Experimental: Partially Hydrolysed Whey Formula Group (pHFG)
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.
Dietary supplement: Partially Hydrolysed Whey Formula
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin barrier function
Time Frame: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months)
Change in Trans-epidermal water loss (TEWL)
Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
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
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).
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
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.
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)
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.
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
Time Frame: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months)
Using the Infant Gastrointestinal Symptom Questionnaire (IGSQ)-13.
Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months)
Toddler gut comfort
Time Frame: Study Month 9 (age 12 months) and Study Month 15 (age 18 months)
Using the Toddler Gut Comfort Questionnaire.
Study Month 9 (age 12 months) and Study Month 15 (age 18 months)
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.
Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months)
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.
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)
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Société des Produits Nestlé (SPN)

Collaborators

Medidata Solutions
Veeva Systems
SAS Institute
Cognizant Technology Solutions AG

Investigators

  • Principal Investigator: Jie Shao, Dr., Shanghai Tonxin Pediatric Clinic Co. Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2021

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

November 19, 2020

First Submitted That Met QC Criteria

February 18, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 22, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20.16.INF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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