An interventional study of Oral immunotherapy with cow's milk in Milk Allergy, Cow's, Food Allergy in Children and Food Allergies, sponsored by Laura Ozer Kettner. Not yet recruiting at 5 sites in Denmark. Open to participants aged 6 Months to 18 Months. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Laura Ozer Kettner · Not applicable, Interventional, and Treatment
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:
All children will:
147 studies on the registry are indexed under Milk Hypersensitivity; 26 are open to participants now.
This study's planned enrollment of 56 is below the median of 68 across 95 interventional studies indexed under Milk Hypersensitivity.
Browse Milk Hypersensitivity studies →Laura Ozer Kettner is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Children randomized to avoidance will receive standard care for cow's milk allergy, including avoidance of cow's milk.
Oral immunotherapy with cow's milk for 1-1.5 years
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
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
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
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
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
Parental food allergy related quality of life
Changes in quality of life scores measured by the Food Allergy Quality of Life - Parental Burden Questionnaire
Time frame: 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)
Time frame: 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
Time frame: At enrollment, 1-1.5 years, and 2-2.5 years (end of study) after enrollment
Study dropout
Proportion of children who dropped out
Time frame: 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
Time frame: 2-2.5 years (end of study) after enrollment
Missed oral immunotherapy doses
Proportion of missed oral immunotherapy-doses
Time frame: 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
Time frame: After oral immunotherapy and at 2-2.5 years (end of study) after enrollment
Decision aid
Scores on the Decisional Conflict Scale
Time frame: Right after decision to start oral immunotherapy
Plan to share: No — Individual participant data will not be shared due to ethical and data protection considerations
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Laura Ozer Kettner