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New treatment option for Food Allergy
Official title Stepwise Heat-Denaturated Protein Introduction for Tolerance Induction in Food Allergy
ClinicalTrials.gov ID: NCT06380673
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 18
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bonheiden, Belgium
- Bruges, Belgium
- Ghent, Belgium
- Hasselt, Belgium
- Leuven, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bonheiden, Belgium; Bruges, Belgium; Ghent, Belgium; Hasselt, Belgium; Leuven, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.