Assessing milk ladders for children with cow's milk protein allergy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness and safety of two different milk ladder protocols, a 4-step and a 6-step, for children aged 1 to 5 years with IgE-mediated cow's milk protein allergy (CMPA). The trial is an open-label, randomized superiority design involving 92 children who will be assigned to one of the two protocols. Each child will undergo oral food challenges to assess their tolerance to non-heated cow's milk proteins after following the respective milk ladder protocol. The primary outcome is the percentage of children achieving tolerance by the end of the observation period.

Why it matters

Who can join: the full rules

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

Where it's running

• Medical University od Warsaw, Department od Pediatrics
  Warsaw, Poland Recruiting
• Medical University od Warsaw
  Warsaw, Poland Not yet recruiting

Study contacts

• Principal investigator: Andrea Horvath — Medical University od Warsaw
• Study coordinator: Andrea Horvath, MD, PhD
• Email: andrea.horvath@wum.edu.pl
• Phone: 048223179444

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.