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NCT07895095
Oral Immunotherapy for Children With Peanut Allergy
Conditions: Peanut Allergic Subjects, Peanut Allergies, Peanut Hypersensitivity, Food Allergy Peanut, Food Allergy in Children, Food Allergies
Sex: All
Ages: 6 Months – 48 Months
Healthy volunteers: No
Phase: NA
Enrollment: 56
Sponsor: Laura Ozer Kettner
Location: The Danish Center of Pediatric Pulmonology and Allergology, Department of Pediatrics and Adolescent Medicine, Aarhus University Hospital Aarhus
Summary
This clinical trial aims to investigate if oral immunotherapy can help children with peanut allergy tolerate peanut.
Children aged 6 months to 4 years can take part in the trial.
Main question: What percentage of children can tolerate peanut after oral immunotherapy, compared with children who avoid peanut?
Children are assigned to these two groups by chance.
Children receiving oral immunotherapy will:
* Take a small, increasing amount of peanut daily for 1-1.5 years
* Attend clinic or online visits each time the dose is increased
* Record missed doses
All children will:
* Provide blood samples to measure allergy-related markers
* Undergo an oral food challenge with peanut after 1-1.5 years to assess how much they can tolerate
* Report allergic reactions (parent-reported)
* Complete questionnaires (parent-reported)
* Participate in an end-of-study telephone interview with an allergy nurse (parent-reported)
Eligibility Criteria
Inclusion Criteria:
* Aged 6 to 48 months
* Peanut allergy confirmed at an oral food challenge
* Reaction threshold below 300 mg of peanut protein at the oral food challenge
* Specific IgE to peanut \> 0.35 kU/L
* Family motivated for oral immunotherapy following shared decision-making using a decision aid
Exclusion Criteria:
* Uncontrolled asthma, eczema, rhinoconjunctivitis, urticaria, or eosinophilic esophagitis
* Treatment with biologic or immunosuppressive medication
* Tree nut allergy requiring avoidance of trace amounts
* Non-Danish-speaking families
* Anticipated non-adherent families
Source: ClinicalTrials.gov (NCT07895095). StuddyBuddy aggregates publicly available trial information.