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

Recruiting now · Not applicable

Conditions studied: Cow Milk Allergy, Food Allergy

In brief

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.

Key facts

Study ID

NCT06664918

Run by

Medical University of Warsaw

People needed

92

Starts

2024-12-03

Expected to finish

2029-03-01

Last updated by the study team

2025-03-18

Who can join

Age: 1 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Medical University od Warsaw, Department od Pediatrics — Warsaw, Poland (enrolling)
• Medical University od Warsaw — Warsaw, Poland

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.