Oral Immunotherapy for Children With Cow's Milk Allergy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorLaura Ozer Kettner

About this trial

This clinical trial aims to investigate if oral immunotherapy can help children with cow's milk allergy tolerate cow's milk.

Children aged 6-18 months can take part in the trial.

Main question: What percentage of children can tolerate cow's milk after oral immunotherapy, compared with children who avoid cow's milk?

Children are assigned to these two groups by chance.

Children receiving oral immunotherapy will:

* Take a small, increasing amount of cow's milk 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 cow's milk 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

Qualifiers

Aged 6 to 18 months

Cow's milk allergy confirmed at an oral food challenge

Reaction threshold below 300 mg of cow's milk protein at the oral food challenge

Specific IgE to cow's milk > 0.35 kU/L

Disqualifiers

Uncontrolled asthma, eczema, rhino-conjunctivitis, urticaria, or eosinophilic esophagitis

Treatment with biologic or immunosuppressive medication

Non-Danish-speaking families

Anticipated non-adherent families

Trial design

Treatments tested in this trial

  • Oral immunotherapy with cow's milk

Treatment groups

56 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Laura Ozer Kettner

Lead sponsor

Aarhus University Hospital

Sponsor institution

Randers Regional Hospital

Collaborator

Gødstrup Hospital

Collaborator

Viborg Regional Hospital

Collaborator

Kolding Sygehus

Collaborator