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NOT YET RECRUITING
NCT07768696
NA

Oral Immunotherapy for Children With Cow's Milk Allergy

Sponsor: Laura Ozer Kettner

View on ClinicalTrials.gov

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)

Official title: Oral Immunotherapy for Children With Cow's Milk Allergy: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

6 Months - 18 Months

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2026-09

Completion Date

2031-09

Last Updated

2026-08-17

Healthy Volunteers

No

Interventions

OTHER

Oral immunotherapy with cow's milk

Oral immunotherapy with cow's milk for 1-1.5 years

Locations (5)

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