GOAt Milk Formula-based Ladder Versus Cow's Milk Ladder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-5
SponsorMedical University of Warsaw
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 1 and 5 years.
Diagnosis of IgE-mediated CMA confirmed according to ESPGHAN guidelines, by a positive OFC with CMPs. In high-risk children (i.e., with a history of anaphylaxis occurring more than 6 months before enrolment) diagnosis may be established without a new OFC, based on a positive SPT wheal at least 3 mm greater than negative saline control and elevated specific IgE to CMPs >0.35 kUa/L.
On a cow's milk-free, therapeutic elimination diet for at least 6 months, or since before 12 months of age.
Eligible regardless of the risk of systemic reaction (anaphylaxis) and asthma.
Disqualifiers
Uncontrolled asthma, defined as poor control according to the current GINA criteria, recent exacerbation requiring systemic corticosteroids or the need for medium to high-dose inhaled corticosteroids to maintain control
Signs of acute infectious disease (i.e., acute runny nose, cough, or fever).
Clinically relevant, uncontrolled exacerbation of another allergic disease that, in the investigator's judgement, could compromise OFC interpretation or safety (i.e., conjunctivitis, allergic rhinitis, atopic dermatitis).
History of anaphylaxis due to cow's milk proteins within the last 6 months.
Trial design
Design model
Parallel
Treatments tested in this trial
oral food challenge (OFC)
Other interventionoral 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)
Other interventionoral 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)
Treatment groups
92 Participants
are divided into 2 treatment groupsGroup A: 4-step Goat Milk Formula-Based LadderExperimental treatment 1 intervention
Group B: 4-step Cow's Milk LadderActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Between-group difference in the proportion of children who tolerate non-heated pasteurised cow's milk
The primary outcome will be the between-group difference in the proportion of children who tolerate non-heated pasteurised cow's milk. Tolerance will be defined as the absence of an allergic reaction during an OFC with 120 mL of pasteurised cow's milk, corresponding to 3.96 g of cow's milk protein. In both the 4-CML and 4-GMFL groups, this OFC constitutes Step 4 and the final step of the ladder.
Time frame
Non-heated pasteurised cow's milk will be administered at the end of the observation period (week 12).Secondary outcomes
1
Between-group difference in the proportion of children tolerating the full predefined dose at Steps 1-3
Proportion of participants in each study arm who tolerate the full predefined dose of the ladder products during the OFCs at the first three steps: muffin at baseline, pancake at week 4, baked hard cheese at week 8.
Time frame
Baseline (Step 1), week 4 (Step 2) and week 8 (Step 3)2
Between-group difference in maximum tolerated dose at each ladder step
Maximum tolerated dose of each ladder product during Steps 1-3, expressed both as the absolute amount of the study product and the corresponding milk protein dose.
Time frame
Baseline (Step 1), week 4 (Step 2) and week 8 (Step 3)3
Between-group difference in the percentage of children who experienced anaphylaxis
Between-group difference in the proportion of children who experience anaphylaxis defined as reactions with severity grades 3-5 according to the updated 2023 WAO clinical criteria for anaphylaxis.
Time frame
Measured during the observation period (12 weeks).4
Between-group difference in the proportion of children with anaphylaxis (grades 3-5, per 2023 WAO criteria) who required epinephrine administration
Between-group difference in the proportion of children who experienced anaphylaxis and required epinephrine will be reported in three categories: * those who require one or two doses of intramuscular epinephrine with a good clinical response (less severe reaction, grade 3), * those who require more than 2 doses of intramuscular epinephrine, * those with lack of significant clinical improvement after two doses (severe reactions, grades 4-5).
Time frame
Measured during the observation period (12 weeks).Sponsors and contacts
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Medical University of Warsaw
Lead sponsor
Medical University of Lublin
Collaborator
NYU Langone Health
Collaborator
University of Warmia and Mazury in Olsztyn
Collaborator
Medical University of Lodz
Collaborator
Source ClinicalTrials.gov
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