Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Peanut Allergy
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Care Provider, Investigator)Primary Purpose: Treatment

Participation Requirements

Age
Between 1 years and 3 years
Gender
Both males and females

Description

Problem: Today there is no clinically available treatment for peanut allergy. Oral Immunotherapy (OIT) studies have shown promising results, particularly in younger children (<4 years). Intervention: Peanut OIT in children aged >1 and <4 years with peanut allergy (clinical symptoms at peanut challen...

Problem: Today there is no clinically available treatment for peanut allergy. Oral Immunotherapy (OIT) studies have shown promising results, particularly in younger children (<4 years). Intervention: Peanut OIT in children aged >1 and <4 years with peanut allergy (clinical symptoms at peanut challenge and IgE >0.1 kU /l to peanut and/or Ara h 2). Comparison: Three groups are compared. Peanut allergic children are randomized 2:1 to group 1 (active OIT) or group 2 (control). Group 3 consists of age-matched healthy controls: Group 1; Children with peanut allergy receiving peanut OIT, slow up-dosing, 40-60 weeks, until the maintenance dose 286 mg peanut protein. Three years' treatment. Group 2; Age-matched children with peanut allergy who do not undergo OIT peanut. Peanut challenge one and three years after inclusion. Group 3; Healthy, non-allergic, age-matched children. No challenges are performed in this group. Inclusion of study subjects: A review of samples sent to the Karolinska University Laboratory for IgE-ab responses to peanut/Ara h 2 for children in the Stockholm area aged 1-<4 years is used for identification of potential participants to whom a letter is sent with information about the study. The families are randomized 2:1 to OIT or control group, group 1 or group 2. Children without allergies, healthy Controls (group 3), will be identified through the day surgery at Astrid Lindgren's Children's Hospital. Outcomes: The primary outcome is defined as sustained unresponsiveness to 775 mg peanut protein (cumulative dose) at an open oral peanut challenge 4 weeks after 3 years of OIT was stopped (group 1 and 2). Secondary outcomes are adverse events among peanut allergic children with/without OIT treatment (group 1 and 2), and changes in quality of life parameters and immunological markers (group, 1, 2, 3).

Tracking Information

NCT #
NCT04511494
Collaborators
Not Provided
Investigators
Principal Investigator: Anna Asarnoj Karolinska Institutet