Effectiveness and Safety of Milk Ladders in Children with IgE-Mediated Cow's Milk Protein Allergy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-5
SponsorMedical University of Warsaw
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
oral food challenge (OFC)
Other interventionoral food challenges with subsequent steps of 4-step milk ladder (muffin, pancake,baked hard cheese, yoghurt/pasteurised cow milk or modified cow milk)
oral food challenge (OFC)
Other interventionoral food challenges with subsequent steps of 6-step milk ladder (cookie, muffin, pancake,baked hard cheese, yoghurt, pasteurised cow milk or modified cow milk)
Treatment groups
92 Participants
are divided into 2 treatment groupsGroup A: 4-step milk ladderExperimental treatment 1 intervention
Group B: 6-step milk ladderActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The percentage of children who acquired tolerance to non-heated cow's milk proteins
The percentage of children who acquired tolerance to non-heated cow's milk proteins defined as unreactive patients during OFC with non-heated cow's milk (the last step of milk ladder; a pasteurised cow milk or modified cow milk, the amount of 120-240 ml depending on the age of the patient, max. 7.95 g of CMPs)
Time frame
at the end of the observation period (12 or 20 weeks, depending on the study arm)Secondary outcomes
1
Percentage of children who experienced anaphylaxis
Anaphylaxis defined by the clinical criteria of anaphylaxis according to WAO 2020.
Time frame
during the observation period (12 or 20 weeks, depending on the study arm)2
Percentage of children who required adrenaline administration
Time frame
during the observation period (12 or 20 weeks, depending on the study arm)3
Change in BMI-for-age z-score
Time frame
at the end of the observation period (12 or 20 weeks, depending on the study arm) compared to baseline (before the first OFC)4
Assessment of parents' anxiety about adverse events during their child's OFC
using the Subjective Units of Distress Scale (SUDS); parents will rate their level of anxiety on a scale from 1 to 100, where 0 represents no anxiety or complete relaxation, and 100 represents extreme anxiety, the worst ever experienced.
Time frame
before each OFC, which means before the first OFC and depending on the study arm: after 4,8,12 weeks or after 4,8,12,16,20 weeksSponsors and contacts
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Source ClinicalTrials.gov