Oral Immunotherapy for Children With Cow's Milk Allergy

NCT07768696 | Not Yet Recruiting

• 1 other identifier: 1-10-72-198-25a
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 5

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)

Conditions

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

Keywords

Oral immunotherapy; OIT; Desensitization

Outcome Measures

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

  1-1.5 years after enrollment

Secondary Outcomes (12)

• Early tolerance to cow's milk (4000 mg)

  1 year after enrollment

• Tolerance to cow's milk (1000 mg)

  1-1.5 years after enrollment

• Allergic reactions

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

• Use of adrenaline auto-injector

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

• Parental food allergy related quality of life

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

Study Arms (2)

Oral immunotherapy

EXPERIMENTAL

Children randomized to oral immunotherapy will ingest a daily dose of cow's milk. Dose escalation will be performed approximately every two weeks at the allergy clinic or via online consultations. After approximately 6 months, a maintenance dose of 300 mg food protein will be reached and continued daily for 6-12 months.

Other: Oral immunotherapy with cow's milk

Avoidance

NO INTERVENTION

Children randomized to avoidance will receive standard care for cow's milk allergy, including avoidance of cow's milk.

Interventions

Oral immunotherapy with cow's milk OTHER

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

Oral immunotherapy

Eligibility Criteria

• Age: 6 Months - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Uncontrolled asthma, eczema, rhino-conjunctivitis, urticaria, or eosinophilic esophagitis
• Treatment with biologic or immunosuppressive medication
• Non-Danish-speaking families
• Anticipated non-adherent families

Sponsors & Collaborators

• Randers Regional Hospital: collaborator
• Kolding Sygehus: collaborator
• Laura Ozer Kettner: lead
• Gødstrup Hospital: collaborator
• Viborg Regional Hospital: collaborator

Study Sites (5)

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

Aarhus, Denmark

Location

Regional Hospital Gødstrup

Gødstrup, Denmark

Location

Regional Hospital Kolding

Kolding, Denmark

Location

Regional Hospital Randers

Randers, Denmark

Location

Regional Hospital Viborg

Viborg, Denmark

Location

Related Publications (4)

• Turner PJ, Ansotegui IJ, Campbell DE, Cardona V, Carr S, Custovic A, Durham S, Ebisawa M, Geller M, Gonzalez-Estrada A, Greenberger PA, Hossny E, Irani C, Leung ASY, Levin ME, Muraro A, Oppenheimer JJ, Ortega Martell JA, Pouessel G, Rial MJ, Senna G, Tanno LK, Wallace DV, Worm M, Morais-Almeida M; WAO Anaphylaxis Committee and WAO Allergen Immunotherapy Committee. Updated grading system for systemic allergic reactions: Joint Statement of the World Allergy Organization Anaphylaxis Committee and Allergen Immunotherapy Committee. World Allergy Organ J. 2024 Feb 10;17(3):100876. doi: 10.1016/j.waojou.2024.100876. eCollection 2024 Mar.

  PMID: 38361745 BACKGROUND

• O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.

  PMID: 7898294 BACKGROUND

• To S, Westwell-Roper C, Soller L, Stewart SE, Chan ES. Development of IMPAACT (Impairment Measure for Parental Food Allergy-Associated Anxiety and Coping Tool), a validated tool to screen for food allergy-associated parental anxiety. Ann Allergy Asthma Immunol. 2022 Oct;129(4):451-460.e3. doi: 10.1016/j.anai.2022.02.020. Epub 2022 Mar 4.

  PMID: 35248728 BACKGROUND

• Cohen BL, Noone S, Munoz-Furlong A, Sicherer SH. Development of a questionnaire to measure quality of life in families with a child with food allergy. J Allergy Clin Immunol. 2004 Nov;114(5):1159-63. doi: 10.1016/j.jaci.2004.08.007.

  PMID: 15536425 BACKGROUND

MeSH Terms

Conditions

Milk Hypersensitivity; Food Hypersensitivity

Interventions

Immunotherapy; Milk

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Laura O Kettner, MD, PhD

  The Danish Center of Pediatric Pulmonology and Allergology, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura O Kettner, MD, PhD

CONTACT

+45 51703229; lauchr@rm.dk

Sune LM Rubak, MD, PhD

CONTACT

+45 51729258; sunerubak@skejby.rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 17, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2031
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (5)