Actively Recruiting
Led by Medical University of Warsaw · Updated on 2025-03-18
92
Participants Needed
2
Research Sites
12 weeks
Total Duration
Cow's milk protein allergy (CMPA) is a common food allergy in young children, and the main treatment is avoiding cow's milk proteins. Researchers are studying how children with IgE-mediated CMPA develop tolerance to cow's milk proteins over time. This trial compares the effectiveness and safety of two milk introduction methods called the 4-step milk ladder (4-ML) and the 6-step milk ladder (6-ML) to see which better helps children build tolerance to cow's milk. Children aged 1 to 5 years with IgE-mediated CMPA will be randomly assigned to follow either the 4-step or 6-step milk ladder protocol. Both involve gradually introducing baked and non-heated milk products in increasing amounts with a 4-week break between each step. Oral food challenges (OFCs) will be done in the hospital at each step to test tolerance. The 4-ML group will be observed for 12 weeks, while the 6-ML group for 20 weeks. During the study, children will be monitored for allergic reactions, including anaphylaxis and atopic dermatitis flare-ups, growth changes, and treatment adherence. Parents' anxiety and quality of life will also be assessed. The main measurement is the percentage of children who tolerate non-heated cow's milk proteins without reaction at the end of the observation period. The study will evaluate these outcomes through clinical tests and questionnaires over the treatment duration.
CONDITIONS
Effectiveness and Safety of Milk Ladders in Children with IgE-Mediated Cow's Milk Protein Allergy
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks for 4-step milk ladder or 20 weeks for 6-step milk ladder
Participants introduce baked milk into their diet through either a 4-step or 6-step milk ladder, with oral food challenges conducted at each step in hospital settings to assess tolerance.
Multiple oral food challenge visits at each step with a 4-week break between steps
Duration - Up to the end of the 12 or 20 week observation period depending on study arm
Participants are observed for development of tolerance to non-heated cow's milk proteins and monitored for safety outcomes including allergic reactions and quality of life assessments.
Visits coincide with oral food challenges and assessments before and after each step
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
A
Andrea Horvath, MD, PhD
D
Daria Wiszniewska, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Daria Wiszniewska, Andrea Horvath, Agata Stróżyk...
https://pubmed.ncbi.nlm.nih.gov/40228856