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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Oral immunotherapy with cow's milk for 1-1.5 years
The Danish Center of Pediatric Pulmonology and Allergology, Department of Pediatrics and Adolescent Medicine, Aarhus University Hospital
Aarhus, Denmark
Regional Hospital Gødstrup
Gødstrup, Denmark
Regional Hospital Kolding
Kolding, Denmark
Regional Hospital Randers
Randers, Denmark
Regional Hospital Viborg
Viborg, Denmark
Tolerance to cow's milk (4000 mg)
Proportion of children who tolerate a cumulative dose of 4343 mg of cow's milk protein at an oral food challenge
Time frame: 1-1.5 years after enrollment
Early tolerance to cow's milk (4000 mg)
Proportion of children, with a 50% or greater reduction in cow's milk-specific IgE after 1 year, who tolerate a cumulative dose of 4343 mg of cow's milk protein at an oral food challenge
Time frame: 1 year after enrollment
Tolerance to cow's milk (1000 mg)
Proportion of children who tolerate a cumulative dose of 1343 mg of cow's milk protein at an oral food challenge
Time frame: 1-1.5 years after enrollment
Allergic reactions
Proportion of children experiencing allergic reactions, graded by the World Allergy Organization grading system
Time frame: 1-1.5 years and 2-2.5 years (end of study) after enrollment
Use of adrenaline auto-injector
Proportion of children who used an adrenaline auto-injector due to allergic reactions
Time frame: 1-1.5 years and 2-2.5 years (end of study) after enrollment
Parental food allergy related quality of life
Changes in quality of life scores measured by the Food Allergy Quality of Life - Parental Burden Questionnaire
Time frame: At enrollment, 1-1.5 years, and 2-2.5 years (end of study) after enrollment
Parental food allergy related anxiety
Changes in anxiety scores measured by the Impairment Measure for Parental Food Allergy-Associated Anxiety and Coping Tool (IMPAACT)
Time frame: At enrollment, 1-1.5 years, and 2-2.5 years (end of study) after enrollment
Biomarkers
Changes in specific IgEs and Basophil Activation Test
Time frame: At enrollment, 1-1.5 years, and 2-2.5 years (end of study) after enrollment
Study dropout
Proportion of children who dropped out
Time frame: 1-1.5 years and 2-2.5 years (end of study) after enrollment
Regular cow's milk intake
Proportion of children with regular intake of cow's milk after allergy resolves
Time frame: 2-2.5 years (end of study) after enrollment
Missed oral immunotherapy doses
Proportion of missed oral immunotherapy-doses
Time frame: During up-dosing and maintenance phase
Is oral immunotherapy worth it
Proportion of families who considered oral immunotherapy worthwhile, and their reported key benefits and burdens
Time frame: After oral immunotherapy and at 2-2.5 years (end of study) after enrollment
Decision aid
Scores on the Decisional Conflict Scale
Time frame: Right after decision to start oral immunotherapy
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