Post-failure Stepwise Heat-Denaturated Protein Introduction for Tolerance Induction in Cow's Milk Allergy Observational Cohort Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cow's Milk Protein Allergy. Basic parameters: 1 year — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Subjects who failed to become tolerant within 12 months after randomization within one of the three arms in the TEHITI study, can participate in the post-TEHITI observational trial to study the natural tolerance induction process.
Detailed description
In this observational study the investigators will study the time to complete tolerance in cow's milk allergic children who tolerate 20' heated milk but failed the OFC with unheated milk 12 months after passing the 20' boiled cow's milk OFC. Moreoever, the investigators want to document all clinical reactions and potential cofactors during the tolerance induction process. The investigators anticipate that the whole cohort will become tolerant in a time span shorter than 48 months. Therefore the study period in each participant will be 48 months or the period to achieve complete tolerance (which comes first).
Primary outcome measures
- Number of participants that acquire tolerance for cow's milk after initially failing a cow's milk provocation test [Time frame: 48 months]
Secondary outcome measures (1)
- Adverse clinical reactions to cow's milk protein intake during observational period [Time frame: 48 months]
Eligibility criteria
Inclusion criteria
Participants eligible for inclusion in this study must meet all of the following criteria:
- participation in s68299
- failure to challenge test with unheated cow's milk
- passed challenge test with unheated cow's milk but with symptoms developing between challenge and termination visit related to cow's milk intake at home
Exclusion criteria
Participants eligible for this study must not meet any of the following criteria:
- Subjects not priorly enrolled in s68299
- Subjects enrolled in s68299 who passed the challenge test and have no complaints upon regular cow's milk consumption at termination visit
- Subjects who refuse to consent/assent with the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Belgium · 5 centers
- Imelda Hospital — Bonheiden
- AZ Sint Jan — Bruges
- AZ Maria Middelares — Ghent
- Jessa Hospital — Hasselt
- UZ Leuven Gasthuisberg — Leuven
Identifiers
NCT: NCT07448740 · S68469