An interventional study of oral food challenge (OFC) and oral food challenge (OFC) in Food Allergy, Cow's Milk Protein Allergy and Cow's Milk Allergy, sponsored by Medical University of Warsaw. Not yet recruiting at 2 sites in Poland. Open to participants aged 1 Year to 5 Years. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Medical University of Warsaw · Not applicable, Interventional, and Treatment
Children with immunoglobulin E (IgE)-mediated cow's milk allergy (CMA) who react to small amounts of baked cow's milk may require prolonged elimination. Preliminary observations suggest that some may tolerate products prepared with a low-αs1-casein goat milk formula. This study will compare a four-step goat milk formula-based ladder (4-GMFL) with a four-step cow's milk ladder (4-CML).
This exploratory open-label, multicentre, randomised trial will enroll 92 children aged 1-5 years with IgE-mediated CMA, allocated 1:1 to the 4-GMFL or 4-CML group. Both ladders comprise muffin, pancake and baked hard cheese, introduced at 4-week intervals and assessed by open, physician-supervised oral food challenges (OFCs) in hospital, followed by a final OFC with 120 mL of non-heated pasteurised cow's milk at week 12.
The primary outcome will be tolerance to non-heated cow's milk protein at this final step, defined as a negative OFC with 120 mL of pasteurised cow's milk containing 3.96 g of protein. Secondary outcomes will include tolerance to individual ladder products, allergic reactions, anaphylaxis, intramuscular adrenaline use, anthropometric changes, food allergy-related quality of life, caregiver anxiety and adherence. Molecular sensitisation profiles will be explored as potential predictors of OFC outcomes.
Goat's milk differs from cow's milk in casein composition, protein structure and digestibility. Recent data suggest that these differences may modify IgE recognition and allergenic potential. This study is based on the hypothesis that repeated exposure to goat milk formula-containing products may provide a different pattern of allergen exposure from that achieved with a conventional cow's milk ladder.
This study aims to assess the effectiveness and safety of the 4-step goat milk formula-based ladder (4-GMFL) compared to the 4-step cow's milk ladder (4-CML) in children with IgE-mediated cow's milk allergy.
An exploratory open-label randomised trial with two parallel arms in two departments: the Department of Paediatrics, Medical University of Warsaw, and the Department of Paediatrics and Allergy, Copernicus Memorial Hospital, Medical University of Lodz, will be performed. A total of 92 children with IgE-mediated cow's milk allergy will be allocated to introduce cow's milk into their diet according to either 4-GMFL or 4-CML with a 4-week break period between subsequent steps. Oral food challenge (OFCs) with tested products - muffin with goat or cow's milk formula, pancake with goat or cow's milk formula, baked goat or cow's milk hard cheese, pasteurised cow's milk - at each subsequent steps of the ladders will be conducted in hospital settings. In both groups, the final 4th ladder step is identical and will assess whether tolerance to the assigned ladder products is accompanied by tolerance to cow's milk protein.
The primary outcome will be the between-group difference in the proportion of children who acquire tolerance to non-heated pasteurised cow's milk, as determined by a negative OFC at the final step of the 4-GMFL or 4-CML. Cow's milk will be administered at the end of the observation period (12 weeks). The challenge dose will consist of 120 mL of pasteurised cow's milk, corresponding to 3.96 g of cow's milk protein.
Secondary outcomes will include between-group difference in the proportion of children with negative OFCs to each ladder steps; between-group difference in the percentage of children with anaphylaxis who required epinephrine administration; between-group difference in the percentage of children with exacerbation of atopic dermatitis; growth; compliance; Food Allergy Quality of Child's Life and the caregivers and parents' anxiety about adverse events during their child's OFC.
The statistical analyses will be conducted with StatsDirect. The Mann-Whitney U test will be used to compare the means of continuous variables if non-normal distribution will be assessed. Proportions will be compared with the Fisher exact test. The difference in study groups was considered significant when the P value will be \<05. The results of this study will be analyzed on the basis of intention to treat.
147 studies on the registry are indexed under Milk Hypersensitivity; 26 are open to participants now.
This study's planned enrollment of 92 is above the median of 68 across 95 interventional studies indexed under Milk Hypersensitivity.
Browse Milk Hypersensitivity studies →Medical University of Warsaw is the lead sponsor of 326 studies on the registry; 87 are open to participants now.
Compared within Milk Hypersensitivity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Food Hypersensitivity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
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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.
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Other: oral food challenge (OFC)
Other: oral food challenge (OFC)
oral food challenges with subsequent steps of a 4-step goat milk formula-based ladder (muffin prepared with goat milk formula, pancake prepared with goat milk formula, baked goat hard cheese, pasteurised cow's milk)
oral food challenges with subsequent steps of a 4-step cow's milk ladder (muffin prepared with cow's milk, pancake prepared with cow's milk, baked cow's milk hard cheese, pasteurised cow's milk)
Between-group difference in the proportion of children who tolerate non-heated pasteurised cow's milk
The primary outcome will be the between-group difference in the proportion of children who tolerate non-heated pasteurised cow's milk. Tolerance will be defined as the absence of an allergic reaction during an OFC with 120 mL of pasteurised cow's milk, corresponding to 3.96 g of cow's milk protein. In both the 4-CML and 4-GMFL groups, this OFC constitutes Step 4 and the final step of the ladder.
Time frame: Non-heated pasteurised cow's milk will be administered at the end of the observation period (week 12).
Between-group difference in the proportion of children tolerating the full predefined dose at Steps 1-3
Proportion of participants in each study arm who tolerate the full predefined dose of the ladder products during the OFCs at the first three steps: muffin at baseline, pancake at week 4, baked hard cheese at week 8.
Time frame: Baseline (Step 1), week 4 (Step 2) and week 8 (Step 3)
Between-group difference in maximum tolerated dose at each ladder step
Maximum tolerated dose of each ladder product during Steps 1-3, expressed both as the absolute amount of the study product and the corresponding milk protein dose.
Time frame: Baseline (Step 1), week 4 (Step 2) and week 8 (Step 3)
Between-group difference in the percentage of children who experienced anaphylaxis
Between-group difference in the proportion of children who experience anaphylaxis defined as reactions with severity grades 3-5 according to the updated 2023 WAO clinical criteria for anaphylaxis.
Time frame: Measured during the observation period (12 weeks).
Between-group difference in the proportion of children with anaphylaxis (grades 3-5, per 2023 WAO criteria) who required epinephrine administration
Between-group difference in the proportion of children who experienced anaphylaxis and required epinephrine will be reported in three categories: * those who require one or two doses of intramuscular epinephrine with a good clinical response (less severe reaction, grade 3), * those who require more than 2 doses of intramuscular epinephrine, * those with lack of significant clinical improvement after two doses (severe reactions, grades 4-5).
Time frame: Measured during the observation period (12 weeks).
Between-group differences in anthropometric changes
Between-group differences in the change in BMI-for-age z-score and length/height-for-age z-score, evaluated using the WHO growth charts.
Time frame: Measured during the observation period (12 weeks).
Between-group difference in the change in the total score of the FAQLQ-PF
The questionnaire is divided into three domains: emotional impact, food anxiety, and social and dietary limitations. The total score is calculated as the mean of three subscales. The minimum score is 0, the maximum score is 6. The lower the score, the more life affecting the allergy is.
Time frame: At the end of the observation period (12 weeks) from baseline.
Between-group differences in caregiver anxiety levels, measured by the Subjective Units of Distress Scale (SUDS)
Parents will rate their level of anxiety on a scale from 1 to 100, where 0 represents no anxiety or complete relaxation, and 100 represents extreme anxiety, the worst ever experienced.
Time frame: Before each OFC at baseline, week 4, week 8 and week 12
Between-group difference in full adherence to the intervention protocol
Between-group difference in the proportion of children with full adherence to the intervention protocol, defined as completion of all scheduled OFCs and home administration of the most recently tolerated ladder product in the prescribed form and dose at least three times per week. Data will be collected through the paper-based Milk Ladder Monitoring Diary during home administration (between the following steps of each ladder).
Time frame: At the end of the observation period (12 weeks).
In the subgroup of children with atopic dermatitis, changes in the total score of the oSCORAD index will be assessed before and after each OFC.
The maximum score on the oSCORAD scale is 83 points (in the most severe cases, an additional 10 points can be added for changes that disfigure or limit the patient's functioning), the minimum score is 0 points; the more points, the greater intensity of changes. Any documented exacerbation of atopic dermatitis symptoms following OFC will be also recorded.
Time frame: Upon completion of the observation period (12 weeks)
Plan to share: Yes — The results of this RCT, whether positive or negative, will be published in a peer-reviewed journal (data will be submitted to the first journal after 3-6 months from study completion). Abstracts will also be submitted to relevant national and international conferences. The datasets used and/or generated during this study will be made available from a given author upon reasonable request, after the publication of results, no later than 3 years from the completion of data analysis.
Supporting information: Study protocol
Time frame: After the publication of results, no later than 3 years from the completion of data analysis with no end date.
Access criteria: Upon reasonable request.
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