Steroid Use in Treatment of Allergic Reactions to Food
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Antihistamines, Systemic corticosteroids, Adrenaline (rescue medication).
- Who it may be relevant to
- Registry conditions: Anaphylactic Reaction, Anaphylaxis, Allergy in Children, IgE Mediated Food Allergy. Basic parameters: 6 months — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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.
Overview
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.
Interventions
- Drug Antihistamines
Oral administration of antihistamines for treatment of allergic symptoms during the oral food challenge. - Drug Systemic corticosteroids
Oral administration of systemic corticosteroids as adjunctive treatment of allergic reactions during the oral food challenge. - Drug Adrenaline (rescue medication)
Intramuscular administration of adrenaline as rescue treatment for severe allergic reactions (anaphylaxis), administered as clinically indicated.
Primary outcome measures
- Time to complete resolution of allergic symptoms [Time frame: From onset of allergic symptoms during the oral food challenge until complete resolution of all allergic symptoms, assessed up to 24 hours.]
Secondary outcome measures (6)
- Total number of adrenaline doses and cumulative adrenaline dose [Time frame: From onset of allergic reaction during the oral food challenge until resolution of symptoms or end of post-reaction observation period, assessed up to 24 hours.]
- Total number of antihistamine doses and cumulative antihistamine dose [Time frame: From onset of allergic reaction during the oral food challenge until resolution of symptoms or end of post-reaction observation period, assessed up to 24 hours.]
- Severity of allergic reaction [Time frame: From onset of allergic reaction during the oral food challenge until resolution of symptoms or end of post-reaction observation period, assessed up to 24 hours.]
- Hospitalization and intensive care unit admission [Time frame: From onset of allergic reaction during the oral food challenge until hospital discharge or end of observation period, assessed up to 24 hours.]
- Time from onset of allergic symptoms to patient discharge [Time frame: From onset of allergic symptoms during the oral food challenge until patient discharge, assessed up to 24 hours.]
- Late-phase allergic reactions [Time frame: From resolution of initial allergic symptoms during the oral food challenge until 24 hours after onset of the allergic reaction.]
Eligibility criteria
Inclusion criteria
- suspected or confirmed IgE-mediated food allergy
Exclusion criteria
- Non-IgE mediated food allergies
- Non-food allergies
- Age outside the specified range
- Contraindications for an oral food challenge or oral steroid use within one week before the challenge.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Switzerland · 2 centers
- University Children's Hospital Basel — Basel
- University Children's Hospital, Zürich — Zurich
Identifiers
NCT: NCT07341776 · BASEC-2025-00320 · HumRes67580 · SNCTP000006696