Peanut OIT; intervention group | |||||||
Study phase | Screening | Treatment | End of treatment | End of study | |||
Week of study | Up to −24 | 0 | 2–12 | 16–48 | 52 (up to 56) | +4 from EOT | |
Visit category | Screening visit | Entry OFC | Initiation | Updosing | Maintenance | Exit OFC | |
Duration | 2 hours | 5–6 hours | 4 hours | 2–3 hours | 15 min remote | 5–6 hours | 15 min remote |
Procedure | |||||||
Informed consent | X | ||||||
Eligibility criteria | X | X | X | ||||
Demographics, medical and family history | X | ||||||
Anthropometrics, vital signs, physical exam, SCORAD | X | X | X | X | X | ||
Questionnaires | X | X—12 weeks | X—24 weeks | X | |||
Skin prick test | X | X | |||||
Blood, stool and saliva samples | X | (X) | X—12 weeks | X | |||
Oral food challenge | X | X | |||||
Adverse event, concomitant medication assessment | X | X | X | X | X | X | |
Anaphylaxis education | X | X | X | X | |||
OIT doses at site | X | X | |||||
OIT dosing education | X | X |
EOT, end of treatment; OFC, oral food challenge; OIT, oral immunotherapy; SCORAD, SCORing of Atopic Dermatitis.