Stepwise Heat-Denaturated Protein Introduction for Tolerance Induction in Food Allergy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-18
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
This interventional study aims to validate an early heated protein introduction protocol in cow's milk allergic children who already developed tolerance towards extensively heated cow's milk, in order to speed up the development of complete cow's milk tolerance. Natural complete tolerance induction towards cow's milk takes several years of strict cow's milk avoidance with high risk of anaphylaxis by accidental cow's milk intake. By shortening the time towards complete tolerance, not only the quality of life of both children and parents ameliorates drastically, the time frame for potential anaphylactic reactions is also strongly reduced and can be considered as a preventive strategy to reduce allergic reactions too. Moreover, this strategy has proved efficient for hen's egg allergy. The main question this study wants to answer is whether a 12 months stepwise heated cow's milk introduction (either by gradual reduction of the cooking time or by the use of the Flemish Milk Ladder) in 20'-cooked cow's milk tolerant subjects, results in a larger proportion of complete cow's milk tolerant children after 12 months compared to natural tolerance induction (with 20' cooked milk introduction only).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children (1-18y) had or have a clinical diagnosis of IgE mediated cow's milk allergy based on positive history as well as skin prick testing and/or specific IgE detection by CAPtest in an allergy clinic.
Children are at least 12 months old before introduction of heated cow's milk is considered.
Children did not suffer from grade 4 anaphylaxis due to cow's milk-ingestion at presentation.
Children have specific IgE levels to Bos d 8 below 1.2 kU/mL and/or children passed 20' cooked cow's milk provocation test executed on clinical judgement.
Disqualifiers
Children had grade 4 anaphylaxis due to cow's milk ingestion.
Children are younger than 12 months old at the moment of passing 20' cooked cow's milk OFC.
Parents are not able or not willing to adhere to a specific cow's milk protein-containing diet on a regular basis at home.
Multiple food allergy, not compatible with any of the choices in the Flemish Milk Ladder.
Trial design
Design model
Parallel
Treatments tested in this trial
Implementation of cow's milk in decreasingly heated forms
Other interventionImplementation of cow's milk in decreasingly heated forms in cow's milk allergic subjects, tolerant to heated cow's milk, to assess the influence on tolerance induction.
Implementation of heated cow's milk
Other interventionImplementation of heated cow's milk in cow's milk allergic subjects, tolerant to heated cow's milk, to assess the influence on tolerance induction.
No intervention
Other interventionHealthy subjects undergo no intervention.
Treatment groups
90 Participants
are divided into 4 treatment groupsGroup A: Stepwise introduction using gradually shorter heating of cow's milk proteinsOther 1 intervention
Group B: Stepwise introduction using the Flemish Milk LadderOther 1 intervention
Group C: Control arm with introduction of 20' cooked cow's milkOther 1 intervention
Group D: Healthy age-matched subjectsOther 1 intervention
Trial outcomes
Primary outcomes
1
Complete cow's milk tolerance after 12 months of stepwise heated cow's milk introduction
We here want to test the hypothesis that a total period of 12 months stepwise heated cow's milk introduction (either by gradual reduction of the cooking time or by the use of the Flemish Milk Ladder) in 20'-cooked cow's milk tolerant subjects, results in a larger proportion of complete cow's milk tolerant children after 12 months compared to natural tolerance induction (with 20' cooked milk introduction only).
Time frame
12 monthsSecondary outcomes
1
Time to complete tolerance in all three arms
We will study how long it takes for the subjects of each arm to develop complete tolerance toward cow's milk.
Time frame
12 months2
Quality of life in all three arms
We will compare Quality of life (QoL) in each arm by comparing the questionnaires filled out by subjects and their parents in each arm.
Time frame
12 months3
Clinical reactions
We will compare the presence of clinical reactions after food introduction at home in each arm. Clinical reactions could be anaphylaxis, rhinitis, atopic dermatitis and so forth.
Time frame
12 months4
Side effects
We will compare the presence of side effects after food introduction at home in each arm. Side effects could be development of unpleasant taste, refusal of other food, development of eosinophilic esophagitis and so forth.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov