Oral Immunotherapy for Young Children With Peanut Allergy - Small Children OIT (SmaChO)
Peanut Allergy
About this trial
This is an interventional treatment trial for Peanut Allergy focused on measuring Peanut Hypersensitivity, Immunotherapy, Child preschool, Arachis
Eligibility Criteria
Inclusion Criteria:
- Children 1 - <4 years old at inclusion
- Positive baseline challenge at a maximum of the 250 mg peanut protein-dose with at least one objective symptom, or positive peanut challenge performed in the clinic in a similar way within 1 year from study start.
- IgE-ab to peanut and/or Ara h 2 ≥0.1 kUA/l, analyzed within 12 months from start of study
- Written consent for participation in the study from both Guardians
Exclusion Criteria:
- Other serious illness
- Previously life-threatening anaphylaxis (intensive care), regardless of the triggering agent
- A history of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, severe chronic gastroesophageal reflux disease (GERD), symptoms of dysphagia, unclear recurrent GI disorders
- Participation in another intervention study, if included in intervention Group
- Severe uncontrolled asthma
- Ongoing medication with biological drugs or oral steroids
Sites / Locations
- Forskningsenheten Södersjukhuset AB
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
No Intervention
No Intervention
No Intervention
OIT peanut
Peanut avoidance
Healthy controls
Children not reacting at the baseline peanut challenge
Children with peanut allergy receiving peanut OIT. Peanut challenge are done before randomization and one and three years after inclusion. n=50 patients
Children with peanut allergy not undergoing OIT peanut. Peanut challenge are done Before randomization and one and three years after inclusion. n=25 patients
Control Group with non-allergic, age-matched children. No challenges are performed in this group. n=30 patients
Peanut-allergic children not reacting at the baseline peanut challenge, will not be eligible for randomisation. They will have a clinical visit after 1+3 years. No more challenges in this group. n=X patients