NCT06380673: TEHITI

Stepwise Heat-Denaturated Protein Introduction for Tolerance Induction in Food Allergy

Recruiting now NA Last updated 16 May 2024

What this trial tests

NA trial testing Implementation of cow's milk in decreasingly heated forms in Food Allergy in 90 participants. Currently enrolling.

Timeline

22 April 2024

Primary endpoint
30 December 2028

30 December 2029

Quick facts

Lead sponsor	Universitaire Ziekenhuizen KU Leuven
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	90
Start date	22 April 2024
Primary completion	30 December 2028
Estimated completion	30 December 2029
Sites	5 locations across Belgium

Drugs / interventions tested

• Implementation of cow's milk in decreasingly heated forms
• Implementation of heated cow's milk
• No intervention

Conditions studied

• Food Allergy — all drugs for Food Allergy →
• Cow Milk Allergy — all drugs for Cow Milk Allergy →

Sponsor

Universitaire Ziekenhuizen KU Leuven — full company profile →

Who can join

Adults 1 to 18, any sex, with Food Allergy or Cow Milk Allergy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.