Oral Immunotherapy for Young Children With Peanut Allergy - Small Children OIT

  • STATUS
    Recruiting
  • End date
    Dec 10, 2024
  • participants needed
    100
  • sponsor
    Karolinska Institutet
Updated on 10 September 2021

Summary

Open label study with peanut oral immunotherapy (OIT). Peanut allergic children aged >1 and <4 years of age will be randomized 2:1 to:

  1. Peanut OIT with slow up-dosing (40-60 weeks) up to a maintenance dose of 286 mg daily oral peanut protein and
  2. Control group with peanut allergic children who do not undergo OIT.
  3. In addition, a group of healthy children without allergic diseases will be included in the study.

The primary outcome, sustained unresponsiveness (i.e. tolerance) to 600 mg peanut protein after 3 years of OIT, efficacy and safety will be compared between group 1 and 2. Group 3 is a control group for analyses of immunological markers.

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 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).

Details
Condition peanut allergy, allergy to peanuts
Treatment Peanut (bamba)
Clinical Study IdentifierNCT04511494
SponsorKarolinska Institutet
Last Modified on10 September 2021

Eligibility

Yes No Not Sure

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
Clear my responses

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