Hydrolysed Rice Formula Study
NCT06288503
Cow's Milk Protein Allergy, Food Hypersensitivity
Gloucester, Gloucestershire, United Kingdom
View Trial DetailsNCT Number: NCT07448740
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.
Interested in participating?
Request Info1 year–18 year
All sexes
Observational
Imelda Hospital, Bonheiden, Belgium
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).
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Participants eligible for inclusion in this study must meet all of the following criteria:
Exclusion criteria
Participants eligible for this study must not meet any of the following criteria:
Time frame: 48 months
The number of participants that spontaneously acquire tolerance for cow's milk after initially failing a cow's milk provocation test will be counted.
Time frame: 48 months
Nature and condition of clinical reactions in relation to different heated and/or unheated forms of cow's milk protein intake during observational period
Contact information is provided by the study sponsor or research team.
Dominique MA Bullens, Prof, MD
CONTACT
Marleen Jannis
CONTACT
Universitaire Ziekenhuizen KU Leuven
Other
Acronym: Post-TEHITI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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