Visit 1 (V1) | Phone call 1 (PC1) | Visit 2 (V2) | |
---|---|---|---|
Time | 0 weeks, baseline | 2 weeks (± 5 days) after V1 | 3–6 months after V1 ± 14 days |
Informed consent | x | ||
Check eligibility | x | ||
Randomization | x | ||
Demographics/subject characteristics | x | x | |
Family characteristics | x | x | |
Medical history | x | x | |
Review adverse events (AEs) | x | x | |
Review concomitant medication | x | x | x |
Nutritional characteristics | x | x | |
Physical examination | x | x | |
SCORAD, EASIscore (in case of eczema) | x | x | |
Transepidermal water loss measurement (TEWL) | x | x | |
Palmar hyperlinearity | X | ||
Skin prick testing | (x)a | x | |
Skin swabs | x | x | |
Saliva sampling | x | x | |
Stool sampling | x | x | |
Dust sampling | x | x | |
Blood sampling | (x)a | x | |
Oral food challenge | x | ||
Dispensation of the study product | x | ||
Feeding of the study product at the site | x | ||
Review tolerance study product | x | x |