NCT06664918 Effectiveness and Safety of Milk Ladders in Children with IgE-Mediated Cow's Milk Protein Allergy
| NCT ID | NCT06664918 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Warsaw |
| Condition | Cow Milk Allergy |
| Study Type | INTERVENTIONAL |
| Enrollment | 92 participants |
| Start Date | 2024-12-03 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 92 participants in total. It began in 2024-12-03 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Andrea Horvath
PRINCIPAL INVESTIGATOR
Medical University od Warsaw
Frequently Asked Questions
Who can join the NCT06664918 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 5 Years, studying Cow Milk Allergy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06664918 currently recruiting?
Yes, NCT06664918 is actively recruiting participants. Contact the research team at andrea.horvath@wum.edu.pl for enrollment information.
Where is the NCT06664918 trial being conducted?
This trial is being conducted at Warsaw, Poland, Warsaw, Poland.
Who is sponsoring the NCT06664918 clinical trial?
NCT06664918 is sponsored by Medical University of Warsaw. The principal investigator is Andrea Horvath at Medical University od Warsaw. The trial plans to enroll 92 participants.