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Oral Immunotherapy for Children With Cow's Milk Allergy

NCT07768696 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-08-17

No results posted yet for this study

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)

Conditions

  • Milk Allergy, Cow's
  • Food Allergy in Children
  • Food Allergies

Interventions

OTHER

Oral immunotherapy with cow's milk

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

Sponsors & Collaborators

  • Randers Regional Hospital

    collaborator OTHER

  • Gødstrup Hospital

    collaborator OTHER

  • Viborg Regional Hospital

    collaborator OTHER

  • Kolding Sygehus

    collaborator OTHER

  • Laura Ozer Kettner

    lead OTHER

Principal Investigators

  • Laura O Kettner, MD, PhD · The Danish Center of Pediatric Pulmonology and Allergology, Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
18 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2030-09-30
Completion
2031-09-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07768696 on ClinicalTrials.gov