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GOAt Milk Formula-based Ladder Versus Cow's Milk Ladder
Sponsor: Medical University of Warsaw
Summary
Children with immunoglobulin E (IgE)-mediated cow's milk allergy (CMA) who react to small amounts of baked cow's milk may require prolonged elimination. Preliminary observations suggest that some may tolerate products prepared with a low-αs1-casein goat milk formula. This study will compare a four-step goat milk formula-based ladder (4-GMFL) with a four-step cow's milk ladder (4-CML). This exploratory open-label, multicentre, randomised trial will enroll 92 children aged 1-5 years with IgE-mediated CMA, allocated 1:1 to the 4-GMFL or 4-CML group. Both ladders comprise muffin, pancake and baked hard cheese, introduced at 4-week intervals and assessed by open, physician-supervised oral food challenges (OFCs) in hospital, followed by a final OFC with 120 mL of non-heated pasteurised cow's milk at week 12. The primary outcome will be tolerance to non-heated cow's milk protein at this final step, defined as a negative OFC with 120 mL of pasteurised cow's milk containing 3.96 g of protein. Secondary outcomes will include tolerance to individual ladder products, allergic reactions, anaphylaxis, intramuscular adrenaline use, anthropometric changes, food allergy-related quality of life, caregiver anxiety and adherence. Molecular sensitisation profiles will be explored as potential predictors of OFC outcomes.
Official title: Efficacy and Safety of a Four-step Goat Milk Formula-based Ladder Versus a Four-step Cow's Milk Ladder in Children With IgE-mediated Cow's Milk Allergy: Protocol for the Exploratory GOAL Randomised Controlled Trial.
Key Details
Gender
All
Age Range
1 Year - 5 Years
Study Type
INTERVENTIONAL
Enrollment
92
Start Date
2027-01-02
Completion Date
2030-01-02
Last Updated
2026-08-31
Healthy Volunteers
No
Interventions
oral food challenge (OFC)
oral food challenges with subsequent steps of a 4-step goat milk formula-based ladder (muffin prepared with goat milk formula, pancake prepared with goat milk formula, baked goat hard cheese, pasteurised cow's milk)
oral food challenge (OFC)
oral food challenges with subsequent steps of a 4-step cow's milk ladder (muffin prepared with cow's milk, pancake prepared with cow's milk, baked cow's milk hard cheese, pasteurised cow's milk)
Locations (2)
Department of Paediatrics and Allergy, Copernicus Memorial Hospital, Medical University of Lodz, Łódź, Poland
Lodz, Poland
Medical Univeristy of Warsaw, Department of Paediatrics
Warsaw, Poland