Food Allergy Clinical Trial
— TEHITIOfficial title:
Stepwise Heat-Denaturated Protein Introduction for Tolerance Induction in Food Allergy
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).
Status | Recruiting |
Enrollment | 90 |
Est. completion date | December 30, 2029 |
Est. primary completion date | December 30, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 18 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. - Parents and/or children are not willing to give IC/assent. |
Country | Name | City | State |
---|---|---|---|
Belgium | Imelda Hospital Bonheiden | Bonheiden | |
Belgium | AZ Sint-Jan | Brugge | |
Belgium | AZ Maria Middelares | Ghent | |
Belgium | Jessa Hospital | Hasselt | |
Belgium | UZ Leuven Gasthuisberg | Leuven |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen KU Leuven |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | 12 months | |
Secondary | 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. | 12 months | |
Secondary | 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. | 12 months | |
Secondary | 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. | 12 months | |
Secondary | 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. | 12 months | |
Secondary | IL-10-producing cow's milk specific regulatory T and B cells | We will study the induction of IL-10-producing cow's milk specific Treg cells and Breg cells in vitro paralleling tolerance induction. Blood samples are drawn at enrolment, at challenge and termination visit. | Three times in 12 months | |
Secondary | BATs to mimic the outcome of cow's milk provocation tests | We will study whether we can correlate the results of the in-house developed in vitro Basophil activation tests (BAT) with different heated cow's milk-containing extracts to the results of the cow's milk provocation test after 12 months. Blood samples are drawn at enrolment, at challenge and termination visit. | Three times in 12 months |
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