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

Launched by MEDICAL UNIVERSITY OF WARSAW · Oct 28, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how effective and safe two different milk ladders are for children with cow's milk protein allergy (CMPA). A milk ladder is a step-by-step plan that helps children gradually reintroduce cow's milk into their diet to see if they can safely tolerate it as they grow older. The study specifically compares a 4-step milk ladder to a 6-step one. Researchers want to understand which approach might work better for helping children with this common food allergy.

To be eligible for the trial, children must be between 1 and 5 years old and have a confirmed diagnosis of IgE-mediated CMPA, meaning their allergy is linked to a specific immune response. They should also have been avoiding cow's milk for at least six months. Parents or guardians need to be able to communicate well and give written consent for their child to participate. Throughout the study, families can expect regular check-ins and guidance as their child tries to safely reintroduce milk into their diet. This trial is important because it aims to provide clearer information on how best to help children with CMPA, which can greatly improve their quality of life.

Gender

ALL

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