Clinical Study of Partially Hydrolysed Protein Infant Formula on Trans-epidermal Water Loss (TEWL)
Atopic Dermatitis, Skin Condition
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
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
Experimental
Experimental
Intact Cow's Milk Protein Formula Group (CMFG)
Partially Hydrolysed Whey Formula Group (pHFG)
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.