Milk Allergy, Cow'sNCT07768696
Oral Immunotherapy for Children With Cow's Milk Allergy
A study testing Oral immunotherapy with cow's milk in people with Milk Allergy, Cow's and Food Allergy in Children, run by Laura Ozer Kettner at 5 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 months
- Conditions the study is for
- Milk Allergy, Cow's, Food Allergy in Children, Food Allergies
- What is being tested?
- Oral immunotherapy with cow's milk
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 5 sitesDenmark
- Study dates
- Sep 2026to Sep 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Uncontrolled asthma, eczema, rhino-conjunctivitis, urticaria, or eosinophilic esophagitis
- Treatment with biologic or immunosuppressive medication
- Non-Danish-speaking families
- Anticipated non-adherent families
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Denmark5 sites
The Danish Center of Pediatric Pulmonology and Allergology, Department of Pediatrics and Adolescent Medicine, Aarhus University Hospital
Aarhus
Laura O Kettner, +45 51703229, lauchr@rm.dk
Regional Hospital Gødstrup
Gødstrup
Anette Flugt, +45 78430355, aneflu@rm.dk
Regional Hospital Kolding
Kolding
Signe V Vahlkvist, +45 76363341, Signe.Vahlkvist@rsyd.dk
Regional Hospital Randers
Randers
Lotte Abildgaard, LOTABI@rm.dk
Regional Hospital Viborg
Viborg
Birgitte T Petersen, Birgitte.Petersen@midt.rm.dk
About this study
Official title: Oral Immunotherapy for Children With Cow's Milk Allergy: A Randomized Controlled 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.
Read more
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)
- Being tested
- Oral immunotherapy with cow's milk
- Keywords
- Oral immunotherapy, OIT, Desensitization
- Medical subject headings
- Milk Hypersensitivity, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral immunotherapy with cow's milkOther
Oral immunotherapy with cow's milk for 1-1.5 years
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1-1.5 years after enrollment
Secondary outcomes (12)
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
Measured: 1 year after enrollment
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
Measured: 1-1.5 years after enrollment
Allergic reactions
Proportion of children experiencing allergic reactions, graded by the World Allergy Organization grading system
Measured: 1-1.5 years and 2-2.5 years (end of study) after enrollment
Use of adrenaline auto-injector
Proportion of children who used an adrenaline auto-injector due to allergic reactions
Measured: 1-1.5 years and 2-2.5 years (end of study) after enrollment
Parental food allergy related quality of life
Changes in quality of life scores measured by the Food Allergy Quality of Life - Parental Burden Questionnaire
Measured: At enrollment, 1-1.5 years, and 2-2.5 years (end of study) after enrollment
Parental food allergy related anxiety
Changes in anxiety scores measured by the Impairment Measure for Parental Food Allergy-Associated Anxiety and Coping Tool (IMPAACT)
Measured: At enrollment, 1-1.5 years, and 2-2.5 years (end of study) after enrollment
Biomarkers
Changes in specific IgEs and Basophil Activation Test
Measured: At enrollment, 1-1.5 years, and 2-2.5 years (end of study) after enrollment
Study dropout
Proportion of children who dropped out
Measured: 1-1.5 years and 2-2.5 years (end of study) after enrollment
Regular cow's milk intake
Proportion of children with regular intake of cow's milk after allergy resolves
Measured: 2-2.5 years (end of study) after enrollment
Missed oral immunotherapy doses
Proportion of missed oral immunotherapy-doses
Measured: During up-dosing and maintenance phase
Is oral immunotherapy worth it
Proportion of families who considered oral immunotherapy worthwhile, and their reported key benefits and burdens
Measured: After oral immunotherapy and at 2-2.5 years (end of study) after enrollment
Decision aid
Scores on the Decisional Conflict Scale
Measured: Right after decision to start oral immunotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2030 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Milk Allergy, Cow'sStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laura Ozer Kettner
- Sponsor type
- University, hospital or other
- Collaborators
- Randers Regional Hospital, Gødstrup Hospital, Viborg Regional Hospital, Kolding Sygehus
- Responsible party
- Sponsor-investigator, Laura Ozer Kettner, Aarhus University Hospital
- Investigators
- Laura O Kettner, MD, PhD, Principal investigator, The Danish Center of Pediatric Pulmonology and Allergology, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768696
- Sponsor's protocol ID
- 1-10-72-198-25a
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical and data protection considerations
Publications
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.
PubMed 38361745O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.
PubMed 7898294To 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.
PubMed 35248728Cohen 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.
PubMed 15536425
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Immunotherapy for Children With Cow's Milk Allergy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07768696
- Acronym / sponsor ID
- 1-10-72-198-25a
- Keywords
- Oral immunotherapy, OIT, Desensitization
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Laura Ozer KettnerUniversity, hospital or other
- Collaborators
- Randers Regional Hospital, Gødstrup Hospital, Viborg Regional Hospital, Kolding Sygehus
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral immunotherapy | Experimental | Other: Oral immunotherapy with cow's milkChildren 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. |
| Avoidance | No intervention | –Children randomized to avoidance will receive standard care for cow's milk allergy, including avoidance of cow's milk. |
Who may qualify
- Ages
- 6 to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (4 listed)
- Uncontrolled asthma, eczema, rhino-conjunctivitis, urticaria, or eosinophilic esophagitis
- Treatment with biologic or immunosuppressive medication
- Non-Danish-speaking families
- Anticipated non-adherent families
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral immunotherapy with cow's milkOral immunotherapy with cow's milk for 1-1.5 years | Other | Oral immunotherapy |
Primary outcome
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
12 secondary outcomes
Early tolerance to cow's milk (4000 mg)
Time frame: 1 year after enrollment
Tolerance to cow's milk (1000 mg)
Time frame: 1-1.5 years after enrollment
Allergic reactions
Time frame: 1-1.5 years and 2-2.5 years (end of study) after enrollment
Use of adrenaline auto-injector
Time frame: 1-1.5 years and 2-2.5 years (end of study) after enrollment
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
Parental food allergy related anxiety
Time frame: At enrollment, 1-1.5 years, and 2-2.5 years (end of study) after enrollment
Biomarkers
Time frame: At enrollment, 1-1.5 years, and 2-2.5 years (end of study) after enrollment
Study dropout
Time frame: 1-1.5 years and 2-2.5 years (end of study) after enrollment
Regular cow's milk intake
Time frame: 2-2.5 years (end of study) after enrollment
Missed oral immunotherapy doses
Time frame: During up-dosing and maintenance phase
Is oral immunotherapy worth it
Time frame: After oral immunotherapy and at 2-2.5 years (end of study) after enrollment
Decision aid
Time frame: Right after decision to start oral immunotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Background: PubMed 38361745Turner 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.
- Background: PubMed 7898294O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.
- Background: PubMed 35248728To 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.
- Background: PubMed 15536425Cohen 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical and data protection considerations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura O Kettner, MD, PhD principal investigator
The Danish Center of Pediatric Pulmonology and Allergology, Aarhus University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral immunotherapy with cow's milk in people with Milk Allergy, Cow's and Food Allergy in Children, run by Laura Ozer Kettner at 5 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura O Kettner, MD, PhD (+45 51703229, lauchr@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerance to cow's milk (4000 mg) (time frame: 1-1.5 years after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07768696, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.