Peanut OIT; intervention group | |||||
Study phase | Screening | Standard care | End of treatment | End of study | |
Week of study | Up to −24 | 0–52 | 52 (up to 56) | +4 from EOT | |
Visit category | Screening visit | Entry OFC | Telephone contact every 3 months | Exit OFC | |
Duration | 2 hours | 5–6 hours | 15 min remote | 5–6 hours | 15 min remote |
Procedure | |||||
Informed consent | X | ||||
Eligibility criteria | X | X | |||
Demographics, medical and family history | X | ||||
Anthropometrics, vital signs, physical exam, SCORAD | X | X | X | ||
Questionnaires | X | X—12 weeks and 24 weeks | X | ||
Skin prick test | X | X | |||
Blood, stool and saliva samples | X | (X) | X | ||
Oral food challenge | X | X | |||
Adverse event, concomitant medication assessment | X | X | X | X | |
Anaphylaxis education | X | X | |||
Strict peanut avoidance | X |
EOT, end of treatment; OFC, oral food challenge; OIT, oral immunotherapy; SCORAD, SCORing of Atopic Dermatitis.