Steroid Use in Treatment of Allergic Reactions to Food

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-26

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Anaphylactic Reaction Anaphylaxis Allergy in Children IgE Mediated Food Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Antihistamines

Intervention Type DRUG

Oral administration of antihistamines for treatment of allergic symptoms during the oral food challenge.

Systemic corticosteroids

Intervention Type DRUG

Oral administration of systemic corticosteroids as adjunctive treatment of allergic reactions during the oral food challenge.

Adrenaline (rescue medication)

Intervention Type DRUG

Intramuscular administration of adrenaline as rescue treatment for severe allergic reactions (anaphylaxis), administered as clinically indicated.

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.

Group Type ACTIVE_COMPARATOR

Antihistamines

Intervention Type DRUG

Oral administration of antihistamines for treatment of allergic symptoms during the oral food challenge.

Adrenaline (rescue medication)

Intervention Type DRUG

Intramuscular administration of adrenaline as rescue treatment for severe allergic reactions (anaphylaxis), administered as clinically indicated.

Interventions

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Antihistamines

Oral administration of antihistamines for treatment of allergic symptoms during the oral food challenge.

Intervention Type DRUG

Systemic corticosteroids

Oral administration of systemic corticosteroids as adjunctive treatment of allergic reactions during the oral food challenge.

Intervention Type DRUG

Adrenaline (rescue medication)

Intramuscular administration of adrenaline as rescue treatment for severe allergic reactions (anaphylaxis), administered as clinically indicated.

Intervention Type DRUG

Other Intervention Names

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Dimetindene maleate Levocetirizine Betamethasone Prednisolone Adrenaline

Eligibility Criteria

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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.

Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No