Actively Recruiting
Effectiveness and Safety of Milk Ladders in Children with IgE-Mediated Cow's Milk Protein Allergy
Led by Medical University of Warsaw · Updated on 2025-03-18
92
Participants Needed
2
Research Sites
221 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effectiveness and Safety of Milk Ladders in Children with IgE-Mediated Cow's Milk Protein Allergy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 1 and 5 years
- Diagnosis of IgE-mediated cow's milk protein allergy confirmed by oral food challenge or, in high-risk cases, by skin prick testing or specific IgE
- On a therapeutic elimination diet for at least 6 months or up to 12 months of age
- Eligible regardless of risk of systemic reaction or asthma
- Good overall health
- Parents without language barriers
- Signed informed consent from parents
- Good cooperation with child's guardians
You will not qualify if you...
- Uncontrolled asthma with symptoms despite treatment
- Signs of chronic disease worsening
- Signs of acute infectious disease such as runny nose, cough, or fever
- Signs of worsening other allergic diseases like conjunctivitis, allergic rhinitis, or atopic dermatitis
- Anaphylaxis to cow's milk proteins in the last 6 months
- Use of antihistamines within 3 to 10 days before the challenge
- Acquired tolerance to baked cow's milk proteins or higher milk ladder steps
- Use of immunosuppressive drugs or immunotherapy
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Medical University od Warsaw, Department od Pediatrics
Warsaw, Poland
Actively Recruiting
2
Medical University od Warsaw
Warsaw, Poland
Not Yet Recruiting
Research Team
A
Andrea Horvath, MD, PhD
CONTACT
D
Daria Wiszniewska, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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