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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04763512
• Other study ID #: 20.16.INF
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2021
• Est. completion date: June 2024

Study information

• Verified date: March 2023
• Source: Société des Produits Nestlé (SPN)
• Contact: Jie Shao, Dr
• Phone: +8618917762095
• Email: dr.shaojie[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Days to 49 Days

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Skin Condition
• Skin Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Shanghai Tonxin Pediatric Clinic Co. Ltd	Shanghai	Shanghai

Sponsors (5)

Lead Sponsor	Collaborator
Société des Produits Nestlé (SPN)	Cognizant Technology Solutions AG, Medidata Solutions, SAS Institute, Veeva Systems

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin barrier function	Change in Trans-epidermal water loss (TEWL)	Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months)
Secondary	Weight	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
Secondary	Length	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
Secondary	Head Circumference	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
Secondary	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).	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
Secondary	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.	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
Secondary	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.	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
Secondary	Infant gut comfort	Using the Infant Gastrointestinal Symptom Questionnaire (IGSQ)-13.	Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months)
Secondary	Toddler gut comfort	Using the Toddler Gut Comfort Questionnaire.	Study Month 9 (age 12 months) and Study Month 15 (age 18 months)
Secondary	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.	Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months)
Secondary	Formula acceptance and satisfaction	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
Secondary	Safety assessment: Adverse events (AEs)	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