Steroid Use in Treatment of Allergic Reactions to Food (SAFARI)

Johannes Trueck

Status and phase: Enrolling; Phase 4

Conditions: IgE Mediated Food Allergy; Allergy in Children; Anaphylactic Reaction; Anaphylaxis

Treatments: Drug: Systemic corticosteroids; Drug: Adrenaline (rescue medication); Drug: Antihistamines

Study type: Interventional

Funder types: Other

Identifiers

NCT07341776

BASEC-2025-00320

SNCTP000006696 (Registry Identifier)

HumRes67580 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 6 months to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Antihistamines plus oral steroids

Active Comparator group

Description:

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.

Treatment:

Drug: Antihistamines

Drug: Adrenaline (rescue medication)

Drug: Systemic corticosteroids

Antihistamines only (no steroids)

Active Comparator group

Description:

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.

Treatment:

Drug: Antihistamines

Drug: Adrenaline (rescue medication)