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Effectiveness and Safety of Milk Ladders in Children with IgE-Mediated Cow's Milk Protein Allergy

RecruitingNAAges 1 Year - 5 YearsAllMedical University of Warsaw
NCT06664918 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 t

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age between 1 and 5 years. * Diagnosis of IgE-mediated CMPA confirmed according to ESPGHAN guidelines, by a positive OFC with CMPs. In high-risk children (i.e., with a history of anaphylaxis), diagnosis based on positive skin prick testing and/or elevated specific IgE to CMPs is sufficient. * On a therapeutic elimination diet for at least 6 months or up to 12 months of age.12 * Eligible regardless of the risk of systemic reaction (anaphylaxis) and asthma. * Good overall health status. * Parents without language barriers. * Written informed consent signed by parents. * Good cooperation with the child's guardians. Exclusion Criteria: * Uncontrolled asthma, defined as the presence of shortness of breath, chest tightness, cough, and/or auscultatory changes despite treatment. * Signs of exacerbation of a chronic disease. * Signs of acute infectious disease (i.e., acute runny nose, cough, subfebrile fever, or fever). * Signs of exacerbation of another allergic disease (i.e., conjunctivitis, allergic rhinitis, atopic dermatitis). * Anaphylaxis due to CMPs in the last 6 months. * Used antihistamines within 3-10 days before the challenge (depending on the characteristics of the drug and the reason for use). * Acquired tolerance to baked CMPs or higher steps of the milk ladder. * Use of immunosuppressive drugs or immunotherapy
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What it tests

  • oral food challenge (OFC)
  • oral food challenge (OFC)
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Where

2 sites
Medical University od Warsaw, Department od Pediatrics
Warsaw, Poland
Medical University od Warsaw
Warsaw, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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