Tolerance induction through non-avoidance to prevent persistent food allergy (TINA) in children and adults with peanut or tree nut allergy: rationale, study design and methods of a randomized controlled trial and observational cohort study

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 V1^a	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		x^b		x
Questionnaire for GI complaints	x		x	x	x
Eating habits questionnaire	x			x^b
Dietary compliance questionnaire			x	x	x
Burden of dietary behavior questionnaire		x		x^b
Oral food challenge	x				x^c
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

ISSN: 1745-6215