Oral Immunotherapy for Children With Cow's Milk Allergy

Oral Immunotherapy for Children With Cow's Milk Allergy: A Randomized Controlled 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)

Inclusion Criteria:

• 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
• High risk of persistent allergy to cow's milk (based on defined criteria)
• Family motivated for oral immunotherapy following shared decision-making using a decision aid

Exclusion Criteria:

• Uncontrolled asthma, eczema, rhino-conjunctivitis, urticaria, or eosinophilic esophagitis
• Treatment with biologic or immunosuppressive medication
• Non-Danish-speaking families
• Anticipated non-adherent families