Health TrialsbyHealthPanel

Oral Immunotherapy for Children With Cow's Milk Allergy

ConditionsMilk Allergy, Cow'sFood Allergy in ChildrenFood Allergies
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorLaura Ozer Kettner

About this 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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Uncontrolled asthma, eczema, rhino-conjunctivitis, urticaria, or eosinophilic esophagitis

Treatment with biologic or immunosuppressive medication

Non-Danish-speaking families

Anticipated non-adherent families

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oral immunotherapy with cow's milk

    Other intervention

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

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: Oral immunotherapyExperimental treatment 1 intervention
Group B: AvoidanceNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Laura Ozer Kettner

Lead sponsor

Aarhus University Hospital

Sponsor institution

Randers Regional Hospital

Collaborator

Gødstrup Hospital

Collaborator

Viborg Regional Hospital

Collaborator

Kolding Sygehus

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: