Table 2.
Adapted SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) figure showing important events and their respective time points during the study period in the cohort study
| Study period | ||||||
|---|---|---|---|---|---|---|
| Enrolment | Observation | |||||
| Visit/Phone Call | Screening including V1a | PC 1 | PC2 | PC3 | V4 | PC4 |
| Time point (months) | 0 | 0.5 | 4 | 8 | 12 | 13 |
| ENROLMENT: | ||||||
| Informed consent | x | |||||
| Eligibility screen | x | |||||
| ASSESMENTS: | ||||||
| Demographics/subject characteristics | x | |||||
| Household/family characteristics | x | x | ||||
| Medical and allergy history | x | x | ||||
| Dietary history | x | |||||
| Physical Examination | x | x | ||||
| SCORAD, EASI score | x | x | ||||
| TEWL | x | x | ||||
| SPT | x | x | ||||
| Skin swab | x | x | ||||
| Saliva sampling | x | x | ||||
| Stool sampling | x | x | ||||
| Dust sampling | x | x | ||||
| Blood sampling | x | x | ||||
| Quality of life questionnaires | x | x | xb | x | ||
| Questionnaire for GI complaints | x | x | x | x | ||
| Eating habits questionnaire | x | xb | ||||
| Dietary compliance questionnaire | x | x | x | |||
| Burden of dietary behavior questionnaire | x | xb | ||||
| Oral food challenge | x | xc | ||||
| Review of concomitant medication | x | x | x | x | ||
| Review of compliance and tolerance | x | x | x | x | ||
Abbreviations: V Visit, PC Phone call, SCORAD Scoring atopic dermatitis, EASI Eczema area and severity index, TEWL Transepidermal water loss measurement, SPT Skin prick testing, GI Gastointestinal
a = Screening period including V1 can last up to 14 days. The first day of the oral food challenge is defined as the first day of the screening period
b = anytime between PC3 and V4
c = at V4 the OFC consist of one feeding of the cumulative dose only