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NCT Number: NCT07768696

Oral Immunotherapy for Children With Cow's Milk Allergy

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)

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Key information

Conditions

Milk Allergy, Cow's Food Allergies Food Allergy in Children Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Milk Hypersensitivity

Age range

6 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Danish Center of Pediatric Pulmonology and Allergology, Department of Pediatrics and Adolescent Medicine, Aarhus University Hospital, Aarhus, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral immunotherapy with cow's milk

Other

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

Primary outcomes

  1. Tolerance to cow's milk (4000 mg)

    Time frame: 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 outcomes

  1. Early tolerance to cow's milk (4000 mg)

    Time frame: 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

  2. Tolerance to cow's milk (1000 mg)

    Time frame: 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

  3. Allergic reactions

    Time frame: 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

  4. Use of adrenaline auto-injector

    Time frame: 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

  5. Parental food allergy related quality of life

    Time frame: 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

  6. Parental food allergy related anxiety

    Time frame: 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)

  7. Biomarkers

    Time frame: At enrollment, 1-1.5 years, and 2-2.5 years (end of study) after enrollment

    Changes in specific IgEs and Basophil Activation Test

  8. Study dropout

    Time frame: 1-1.5 years and 2-2.5 years (end of study) after enrollment

    Proportion of children who dropped out

  9. Regular cow's milk intake

    Time frame: 2-2.5 years (end of study) after enrollment

    Proportion of children with regular intake of cow's milk after allergy resolves

  10. Missed oral immunotherapy doses

    Time frame: During up-dosing and maintenance phase

    Proportion of missed oral immunotherapy-doses

  11. Is oral immunotherapy worth it

    Time frame: 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

  12. Decision aid

    Time frame: Right after decision to start oral immunotherapy

    Scores on the Decisional Conflict Scale

Study contacts

Contact information is provided by the study sponsor or research team.

Laura O Kettner, MD, PhD

CONTACT

[email protected]

+45 51703229

Sune LM Rubak, MD, PhD

CONTACT

[email protected]

+45 51729258

Sponsors and collaborators

Lead sponsor

Laura Ozer Kettner

Other

Collaborators

  • Gødstrup Hospital
  • Kolding Sygehus
  • Randers Regional Hospital
  • Viborg Regional Hospital

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Aug 17, 2026
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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