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| Name | Class |
|---|---|
| Medidata Solutions | INDUSTRY |
| SAS Institute | INDUSTRY |
| Veeva Systems | INDUSTRY |
| Cognizant Technology Solutions AG |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intact Cow's Milk Protein Formula Group (CMFG) | Experimental | All enrolled subjects will be fed Stage 1 CMF libitum for 4 months. Thereafter, they will discontinue study formula and complete the study. |
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| Partially Hydrolysed Whey Formula Group (pHFG) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Skin barrier function | Change in Trans-epidermal water loss (TEWL) | Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Length |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jie Shao, Dr. | Shanghai Tonxin Pediatric Clinic Co. Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Tonxin Pediatric Clinic Co. Ltd | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D012871 | Skin Diseases |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| UNKNOWN |
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| 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. |
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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 | 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 | 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 | 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) | 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 | Using the Infant Gastrointestinal Symptom Questionnaire (IGSQ)-13. | Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months) |
| Toddler gut comfort | Using the Toddler Gut Comfort Questionnaire. | Study Month 9 (age 12 months) and Study Month 15 (age 18 months) |
| 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) |
| 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 |
| 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 |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |