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

Effectiveness and Safety of the 4-Step Versus 6-Step Milk Ladder in Children with IgE-Mediated Cow's Milk Protein Allergy: Protocol for an Open-Label Randomised Controlled Trial

This study is testing two different milk ladder plans to see which one helps young children with a cow's milk allergy tolerate milk better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 92 (estimated)
• Ages: 1 Year to 5 Years
• Sex: All
• Sponsor: Medical University of Warsaw (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 2 sites (Warsaw and 1 other locations)
• Trial ID: NCT06664918 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are children aged 1 to 5 years with a confirmed diagnosis of IgE-mediated CMPA who have been on a therapeutic elimination diet.

Not a fit: Patients with uncontrolled asthma or other significant chronic diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a standardized approach to help children with CMPA develop tolerance to cow's milk, improving their quality of life.

How similar studies have performed: While there is limited scientific evidence regarding the effectiveness of milk ladders, this approach is being tested in a structured manner, making it a novel investigation.

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

Where this trial is running

Warsaw and 1 other locations

• 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

Conditions Cow Milk Allergy; Food Allergy; IgE-mediated cow's milk allergy; children; milk ladder