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
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