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.
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
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
Children participating in study s68299 who fail the challenge test with unheated cow's milk 12 months after initiation of the TEHITI trial, can be enrolled in this post-TEHITI study. Upon IC (and assent if appropriate) parents (and children) can participate in the current post-TEHITI observational trial. Upon enrollment in the post-TEHITI trial, specific data will be pseudonymised and collected during the clinical follow-up visits: * Intake of cow's milk containing food products: amount, recipe, frequency of intake in the period between two follow-up consultations * Clinical reactions: description and recording of potential cofactors for their presentation * Medication use to treat the clinical reaction * Relation to cow's milk intake: certain/doubtful/absent * Specific IgE to cow's milk proteins in peripheral blood * Total IgE levels in peripheral blood Individual pseudonymisation will be done by similar code as given in TEHITI trial.
Cohort
Prospective
Not listed
Number of participants that acquire tolerance for cow's milk after initially failing a cow's milk provocation test
The number of participants that spontaneously acquire tolerance for cow's milk after initially failing a cow's milk provocation test will be counted.
Adverse clinical reactions to cow's milk protein intake during observational period
Nature and condition of clinical reactions in relation to different heated and/or unheated forms of cow's milk protein intake during observational period
Click on the lead sponsor to view all of their trials.
Universitaire Ziekenhuizen KU Leuven
Lead sponsor
Jessa Hospital
Collaborator
Imelda Hospital, Bonheiden
Collaborator
Algemeen Ziekenhuis Maria Middelares
Collaborator
AZ Sint-Jan AV
Collaborator
