An interventional study of oral food challenge (OFC) and oral food challenge (OFC) in Cow Milk Allergy and Food Allergy, sponsored by Medical University of Warsaw. Recruiting at 2 sites in Poland. Open to participants aged 1 Year to 5 Years. Per ClinicalTrials.gov, last updated 2025-03-18.
Sponsored by Medical University of Warsaw · Not applicable, Interventional, and Treatment
Cow's milk protein allergy (CMPA) is one of the most common food allergies in early childhood. The first-line treatment of CMPA is the elimination of cow's milk proteins (CMPs) from the child's or maternal diet.
Available data from the literature indicate that most children with CMPA acquire tolerance to CMPs with age. An assessment of tolerance acquisition to CMPs is commonly performed using milk ladder. However, scientific evidence regarding the effectiveness and safety of the milk ladder in children with CMPA is limited. Currently, there is no standardised milk ladder protocol, and different versions of the ladder and recommend by scientific societies in various countries.
This study aims to assess the effectiveness and safety of the 4-step milk ladder (4-ML) compared to the 6-step milk ladder (6-ML) in children with IgE-mediated CMPA. This is an open-label, randomised superiority trial with two parallel arms and a 1:1 allocation ratio.
Introducing baked milk into the diet of children with cow's milk protein allergy (CMPA) has been shown to potentially accelerate the development of tolerance to raw milk. However, there is no standardised milk ladder protocol, and different scientific societies across countries recommend varying versions.
This study aims to assess the effectiveness and safety of the 4-step milk ladder (4-ML) compared to the 6-step milk ladder (6-ML) in children with IgE-mediated CMPA.
We will perform an open-label randomised trial with two parallel arms in two departments of the same academic hospital. A total of 92 children with IgE-mediated CMPA will be allocated to introduce cow's milk into their diet according to either 4-ML or 6-ML with a 4-week break period between subsequent steps. Oral food challenge (OFCs) with tested products at each subsequent step of the milk ladder will be conducted in hospital settings. The primary outcome will be the percentage of children with tolerance to non-heated cow's milk proteins defined as no allergic reaction to non-heated cow's milk (120-240 ml depending on the age of the patient) during the last OFC; measured at the end of the 12-week observation period for the 4-ML and 20-week observation period for the 6-ML. Secondary outcomes will include the percentage of children with a negative OFC to each milk ladder step; the percentage of children with anaphylaxis (both those who were treated and who were not treated with adrenaline); the percentage of children with exacerbation of atopic dermatitis; growth; compliance; and quality of life of 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.
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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.
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.
Other: oral food challenge (OFC)
Other: oral food challenge (OFC)
oral food challenges with subsequent steps of 4-step milk ladder (muffin, pancake,baked hard cheese, yoghurt/pasteurised cow milk or modified cow milk)
oral food challenges with subsequent steps of 6-step milk ladder (cookie, muffin, pancake,baked hard cheese, yoghurt, pasteurised cow milk or modified cow milk)
The percentage of children who acquired tolerance to non-heated cow's milk proteins
The percentage of children who acquired tolerance to non-heated cow's milk proteins defined as unreactive patients during OFC with non-heated cow's milk (the last step of milk ladder; a pasteurised cow milk or modified cow milk, the amount of 120-240 ml depending on the age of the patient, max. 7.95 g of CMPs)
Time frame: at the end of the observation period (12 or 20 weeks, depending on the study arm)
Percentage of children who experienced anaphylaxis
Anaphylaxis defined by the clinical criteria of anaphylaxis according to WAO 2020.
Time frame: during the observation period (12 or 20 weeks, depending on the study arm)
Percentage of children who required adrenaline administration
Time frame: during the observation period (12 or 20 weeks, depending on the study arm)
Change in BMI-for-age z-score
Time frame: at the end of the observation period (12 or 20 weeks, depending on the study arm) compared to baseline (before the first OFC)
Assessment of parents' anxiety about adverse events during their child's OFC
using 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, which means before the first OFC and depending on the study arm: after 4,8,12 weeks or after 4,8,12,16,20 weeks
In a subgroup of children with atopic dermatitis, the percentage of children with mild, moderate, and severe atopic dermatitis
assessed using the oSCORAD23 scale; the maximum score on this 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
Time frame: before and after each OFC (during the examination following each observation period) which means before and after the first OFC and and before and after subsequent OFCs depending on the study arm: after 4,8,12 weeks or after 4,8,12,16,20 weeks
Percentage of children with full compliance to the intervention protocol
defined as performing all OFCs in the hospital setting and then regular introduction of the milk-containing products according to the individual tolerance following the Study Protocol
Time frame: at the end of the observation period (12 or 20 weeks, depending on the study arm)
Percentage of children with negative OFCs to each cow's milk form after receiving the full planned amount for each OFC
This will be reported as a percentage of children with negative OFCs to each cow's milk form (cookie, muffin, pancake, cheese, yoghurt, milk, if applicable) according to the milk ladder protocol, after receiving the full planned amount for each OFC.
Time frame: at the end of the observation period (12 or 20 weeks, depending on the study arm)
Percentage of children with negative OFCs to each cow's milk form after receiving any tolerated dose
This will be reported as a percentage of children with negative OFCs to each cow's milk form (cookie, muffin, pancake, cheese, yoghurt, milk, if applicable) according to the milk ladder protocol, after receiving any tolerated dose during the trial.
Time frame: after the end of the observation period (12 or 20 weeks, depending on the study arm)
Change in total score of The Food Allergy Questionnaire of Life - Parent Form (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 or 20 weeks, depending on the study arm) compared to baseline (before the first OFC)
Change in length/height-for-age z-score
Time frame: at the end of the observation period (12 or 20 weeks, depending on the study arm) compared to baseline (before the first OFC)
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.
No publications or documents are linked to this record.
Started Dec 2024 (actual). Primary completion is estimated for Dec 2028, 48 months after the start.
Of 34 interventional studies with no phase under Milk Hypersensitivity, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 48. This study's planned 48 months is above that.
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