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RECRUITING
NCT06664918
NA

Effectiveness and Safety of Milk Ladders in Children with IgE-Mediated Cow's Milk Protein Allergy

Sponsor: Medical University of Warsaw

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

1 Year - 5 Years

Study Type

INTERVENTIONAL

Enrollment

92

Start Date

2024-12-03

Completion Date

2029-03

Last Updated

2025-03-18

Healthy Volunteers

No

Interventions

OTHER

oral food challenge (OFC)

oral food challenges with subsequent steps of 4-step milk ladder (muffin, pancake,baked hard cheese, yoghurt/pasteurised cow milk or modified cow milk)

OTHER

oral food challenge (OFC)

oral food challenges with subsequent steps of 6-step milk ladder (cookie, muffin, pancake,baked hard cheese, yoghurt, pasteurised cow milk or modified cow milk)

Locations (2)

Medical University od Warsaw, Department od Pediatrics

Warsaw, Poland

Medical University od Warsaw

Warsaw, Poland