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

Primary Purpose

Atopic Dermatitis, Skin Condition

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intact Cow's Milk Protein Formula
Partially Hydrolysed Whey Formula
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Atopic Dermatitis focused on measuring atopic dermatitis development, trans-epidermal water loss, allergy, growth patterns, quality of life, gut comfort, partially hydrolysed whey

Eligibility Criteria

35 Days - 49 Days (Child)All SexesAccepts 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.

Sites / Locations

  • Shanghai Tonxin Pediatric Clinic Co. LtdRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intact Cow's Milk Protein Formula Group (CMFG)

Partially Hydrolysed Whey Formula Group (pHFG)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Skin barrier function
Change in Trans-epidermal water loss (TEWL)

Secondary Outcome Measures

Weight
Weight in grams and corresponding Z-score according to WHO reference standards and/or local standardized growth charts will be calculated.
Length
Length in centimeters and corresponding Z-score according to WHO reference standards and/or local standardized growth charts will be calculated.
Head Circumference
Head circumference in centimeters and corresponding Z-score according to WHO reference standards and/or local standardized growth charts will be calculated.
Infant health-related quality of life
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).
Infant health-related quality of life
Assessed through the Happy Growth Index Questionnaire with each question rated on a Likert scale from strongly disagree to strongly agree.
Incidence and severity of Atopic Dermatitis (AD) and other allergic manifestations (CMF group)
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.
Infant gut comfort
Using the Infant Gastrointestinal Symptom Questionnaire (IGSQ)-13.
Toddler gut comfort
Using the Toddler Gut Comfort Questionnaire.
Stool consistency
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.
Formula acceptance and satisfaction
Formula intake, acceptability and satisfaction recorded using the Milk Intake and Satisfaction Questionnaire.
Safety assessment: Adverse events (AEs)
Using standard adverse events (AEs) reporting for safety assessment.

Full Information

First Posted
November 19, 2020
Last Updated
March 22, 2023
Sponsor
Société des Produits Nestlé (SPN)
Collaborators
Medidata Solutions, SAS Institute, Veeva Systems, Cognizant Technology Solutions AG
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1. Study Identification

Unique Protocol Identification Number
NCT04763512
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2021 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)
Collaborators
Medidata Solutions, SAS Institute, Veeva Systems, Cognizant Technology Solutions AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Skin Condition
Keywords
atopic dermatitis development, trans-epidermal water loss, allergy, growth patterns, quality of life, gut comfort, partially hydrolysed whey

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intact Cow's Milk Protein Formula Group (CMFG)
Arm Type
Experimental
Arm Description
All enrolled subjects will be fed Stage 1 CMF libitum for 4 months. Thereafter, they will discontinue study formula and complete the study.
Arm Title
Partially Hydrolysed Whey Formula Group (pHFG)
Arm Type
Experimental
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Intact Cow's Milk Protein Formula
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Partially Hydrolysed Whey Formula
Intervention Description
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 Outcome Measure Information:
Title
Skin barrier function
Description
Change in Trans-epidermal water loss (TEWL)
Time Frame
Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months)
Secondary Outcome Measure Information:
Title
Weight
Description
Weight in grams and corresponding Z-score according to WHO reference standards and/or local standardized growth charts will be calculated.
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
Title
Length
Description
Length in centimeters and corresponding Z-score according to WHO reference standards and/or local standardized growth charts will be calculated.
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
Title
Head Circumference
Description
Head circumference in centimeters and corresponding Z-score according to WHO reference standards and/or local standardized growth charts will be calculated.
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
Title
Infant health-related quality of life
Description
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).
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
Title
Infant health-related quality of life
Description
Assessed through the Happy Growth Index Questionnaire with each question rated on a Likert scale from strongly disagree to strongly agree.
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
Title
Incidence and severity of Atopic Dermatitis (AD) and other allergic manifestations (CMF group)
Description
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.
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
Title
Infant gut comfort
Description
Using the Infant Gastrointestinal Symptom Questionnaire (IGSQ)-13.
Time Frame
Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months)
Title
Toddler gut comfort
Description
Using the Toddler Gut Comfort Questionnaire.
Time Frame
Study Month 9 (age 12 months) and Study Month 15 (age 18 months)
Title
Stool consistency
Description
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.
Time Frame
Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months)
Title
Formula acceptance and satisfaction
Description
Formula intake, acceptability and satisfaction recorded using the Milk Intake and Satisfaction Questionnaire.
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
Title
Safety assessment: Adverse events (AEs)
Description
Using standard adverse events (AEs) reporting for safety assessment.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Days
Maximum Age & Unit of Time
49 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Shao, Dr
Phone
+8618917762095
Email
dr.shaojie@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie Shao, Dr.
Organizational Affiliation
Shanghai Tonxin Pediatric Clinic Co. Ltd
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Tonxin Pediatric Clinic Co. Ltd
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie C Shao, Dr
Phone
+8618917762095
Email
liumindr@shphc.org.cn

12. IPD Sharing Statement

Learn more about this trial

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

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