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Evaluation of Emergency Medication in Children With Food Allergies: a Prospective, Randomized Clinical Multicenter Study Comparing Antihistamines Versus Antihistamines Plus Steroids in a Controlled Setting of Oral Food Challenges in Children.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

In this study, the investigators want to find out whether a specific medication commonly used for severe allergic reactions is really necessary. When children have allergic reactions to foods, they are often given medications to relieve the symptoms. In addition to adrenaline and antihistamines, steroids are frequently administered in German-speaking Switzerland. However, it is unclear whether steroids are really helpful in this situation. To investigate this, the investigators are comparing two groups: one group receives additional steroids, and the other does not. Which treatment a participant receives is decided randomly, like flipping a coin. The study takes place during a pre-scheduled provocation test at the clinic. If an allergic reaction occurs, the usual emergency medications will be administered. Doctors will closely monitor how the reaction develops. No additional tests or visits are required. The results of this study could help improve allergy treatment in the future.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 18
Healthy Volunteers: f
View:

• suspected or confirmed IgE-mediated food allergy

Locations
Other Locations
Switzerland
University Children's Hospital Basel
RECRUITING
Basel
University Children's Hospital, Zürich
RECRUITING
Zurich
Contact Information
Primary
Johannes Trück, PD Dr. med. DPhil
johannes.trueck@kispi.uzh.ch
+41 44 249 49 49
Time Frame
Start Date: 2026-01-26
Estimated Completion Date: 2026-12
Participants
Target number of participants: 160
Treatments
Active_comparator: Antihistamines plus oral steroids
Participants receive oral antihistamines plus oral systemic corticosteroids for treatment of allergic reactions occurring during the oral food challenge. Intramuscular adrenaline may be administered as rescue medication if clinically indicated.
Active_comparator: Antihistamines only (no steroids)
Participants receive oral antihistamines without systemic corticosteroids for treatment of allergic reactions occurring during the oral food challenge. Intramuscular adrenaline may be administered as rescue medication if clinically indicated.
Related Therapeutic Areas
Sponsors
Leads: Johannes Trueck
Collaborators: University Children's Hospital Basel

This content was sourced from clinicaltrials.gov