Food Allergies, Food Allergy in Children, Milk Allergy, Cow's
Conditions
Keywords
Oral immunotherapy, OIT, Desensitization
Brief summary
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)
Interventions
OTHEROral immunotherapy with cow's milk
Oral immunotherapy with cow's milk for 1-1.5 years
Sponsors
Laura Ozer Kettner
Randers Regional Hospital
Gødstrup Hospital
Viborg Regional Hospital
Kolding Sygehus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 18 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerance to cow's milk (4000 mg) | 1-1.5 years after enrollment | Proportion of children who tolerate a cumulative dose of 4343 mg of cow's milk protein at an oral food challenge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early tolerance to cow's milk (4000 mg) | 1 year after enrollment | 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 |
| Tolerance to cow's milk (1000 mg) | 1-1.5 years after enrollment | Proportion of children who tolerate a cumulative dose of 1343 mg of cow's milk protein at an oral food challenge |
| Allergic reactions | 1-1.5 years and 2-2.5 years (end of study) after enrollment | Proportion of children experiencing allergic reactions, graded by the World Allergy Organization grading system |
| Use of adrenaline auto-injector | 1-1.5 years and 2-2.5 years (end of study) after enrollment | Proportion of children who used an adrenaline auto-injector due to allergic reactions |
| Parental food allergy related quality of life | At enrollment, 1-1.5 years, and 2-2.5 years (end of study) after enrollment | Changes in quality of life scores measured by the Food Allergy Quality of Life - Parental Burden Questionnaire |
| Parental food allergy related anxiety | At enrollment, 1-1.5 years, and 2-2.5 years (end of study) after enrollment | Changes in anxiety scores measured by the Impairment Measure for Parental Food Allergy-Associated Anxiety and Coping Tool (IMPAACT) |
| Biomarkers | At enrollment, 1-1.5 years, and 2-2.5 years (end of study) after enrollment | Changes in specific IgEs and Basophil Activation Test |
| Study dropout | 1-1.5 years and 2-2.5 years (end of study) after enrollment | Proportion of children who dropped out |
| Regular cow's milk intake | 2-2.5 years (end of study) after enrollment | Proportion of children with regular intake of cow's milk after allergy resolves |
| Missed oral immunotherapy doses | During up-dosing and maintenance phase | Proportion of missed oral immunotherapy-doses |
| Is oral immunotherapy worth it | After oral immunotherapy and at 2-2.5 years (end of study) after enrollment | Proportion of families who considered oral immunotherapy worthwhile, and their reported key benefits and burdens |
| Decision aid | Right after decision to start oral immunotherapy | Scores on the Decisional Conflict Scale |
Countries
Denmark
Contacts
CONTACTLaura O Kettner, MD, PhD
CONTACTSune LM Rubak, MD, PhD
PRINCIPAL_INVESTIGATORLaura O Kettner, MD, PhD
The Danish Center of Pediatric Pulmonology and Allergology, Aarhus University Hospital
Outcome results
None listed