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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Anaphylaxis; IgE Mediated Food Allergy; Allergy in Children; Anaphylactic Reaction
• Intervention / Treatment: Drug: Antihistamines; Drug: Systemic corticosteroids; Drug: Adrenaline (rescue medication)

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Johannes Trück, PD Dr. med. DPhil; Phone Number: +41 44 249 49 49; Email: johannes.trueck@kispi.uzh.ch

Study Locations

• Switzerland
  • Basel
    • Basel, Basel, Switzerland, 4031
      • Recruiting
      • University Children's Hospital Basel
      • Contact: Felicitas Bellutti Enders, Dr. med. PhD; Phone Number: +41 61 704 2770; Email: felicitas.belluttienders@ukbb.ch
  • Canton of Zurich
    • Zurich, Canton of Zurich, Switzerland, 8008
      • Recruiting
      • University Children's hospital, Zürich
      • Contact: Johannes Trück, PD Dr. med. DPhil; Phone Number: +41 44 249 49 49; Email: johannes.trueck@kispi.uzh.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Antihistamines; Oral administration of antihistamines for treatment of allergic symptoms during the oral food challenge.; Other Names: Dimetindene maleate; Levocetirizine; Drug: Systemic corticosteroids; Oral administration of systemic corticosteroids as adjunctive treatment of allergic reactions during the oral food challenge.; Other Names: Prednisolone; Betamethasone; Drug: Adrenaline (rescue medication); Intramuscular administration of adrenaline as rescue treatment for severe allergic reactions (anaphylaxis), administered as clinically indicated.; Other Names: Adrenaline
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.	Drug: Antihistamines; Oral administration of antihistamines for treatment of allergic symptoms during the oral food challenge.; Other Names: Dimetindene maleate; Levocetirizine; Drug: Adrenaline (rescue medication); Intramuscular administration of adrenaline as rescue treatment for severe allergic reactions (anaphylaxis), administered as clinically indicated.; Other Names: Adrenaline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to complete resolution of allergic symptoms	Time from onset of allergic symptoms during the oral food challenge until complete resolution of all allergic symptoms, comparing treatment with antihistamines alone versus antihistamines plus oral steroids.	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

Outcome Measure	Measure Description	Time Frame
Total number of adrenaline doses and cumulative adrenaline dose	Total number of intramuscular adrenaline administrations and cumulative adrenaline dose administered per participant for treatment of allergic reactions during the oral food challenge.	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	Total number of oral antihistamine administrations and cumulative antihistamine dose administered per participant for treatment of allergic reactions during the oral food challenge.	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	Severity of allergic reactions assessed using PRACTALL consensus definitions and documented on a standardized monitoring form during the oral food challenge.	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	Occurrence of hospitalization or admission to an intensive care unit (ICU) for management of allergic reactions occurring during the oral food challenge.	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 from onset of allergic symptoms leading to discontinuation of the oral food challenge until discharge from hospital or outpatient unit.	From onset of allergic symptoms during the oral food challenge until patient discharge, assessed up to 24 hours.
Late-phase allergic reactions	Occurrence of late-phase allergic reactions, defined as recurrence or worsening of allergic symptoms after complete resolution of the initial reaction, without further allergen exposure, following treatment during the oral food challenge.	From resolution of initial allergic symptoms during the oral food challenge until 24 hours after onset of the allergic reaction.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Frequency and severity of adverse events occurring after administration of study medications during the oral food challenge, categorized by type and severity according to standard adverse event definitions.	Up to 24 hours after onset of the allergic reaction.
Rebound allergic symptoms	Occurrence of rebound allergic symptoms, defined as recurrence of allergic symptoms after initial complete resolution, without further allergen exposure, following treatment during the oral food challenge. Severity of rebound symptoms will be documented.	Up to 24 hours after onset of the allergic reaction.
Additional medical interventions	Occurrence and type of additional medical interventions required after initial treatment of an allergic reaction during the oral food challenge, including repeat doses of antihistamines, administration of intramuscular adrenaline, or hospital admission.	Up to 24 hours after onset of the allergic reaction.
Length of hospital stay and intensive care unit stay	Duration of hospital stay and, if applicable, ICU stay for participants admitted due to the allergic reaction during the oral food challenge; prolonged stays beyond the 24-hour assessment window will be recorded as adverse events/serious adverse events.	Through hospital or ICU discharge (up to 24 hours after onset of the allergic reaction).
Prolonged observation period after allergic reaction	Proportion of participants requiring extended clinical observation due to persistent or worsening symptoms after initial treatment during the oral food challenge.	Up to 24 hours after onset of the allergic reaction.
Patient and guardian assessment of symptom severity	Patient- and/or parent/guardian-reported assessment of symptom severity before and after onset of the allergic reaction during the oral food challenge. Symptom severity is assessed using standardized rating tools appropriate for age, including a face-based scale for children and a visual analogue scale (VAS-style) for parents/guardians.	Baseline and up to 24 hours after onset of the allergic reaction.
Pollen exposure and weather conditions on the day of the oral food challenge	Documentation of ambient pollen exposure and weather conditions on the day of the oral food challenge, including pollen burden and relevant meteorological parameters, to allow exploratory assessment of their potential influence on allergic symptom severity and clinical course.	Day of the oral food challenge (Day 0).

Collaborators and Investigators

• Sponsor: Johannes Trueck
• Collaborators: University Children's Hospital Basel

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 5, 2025
• First Submitted That Met QC Criteria: January 7, 2026
• First Posted (Actual): January 14, 2026

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity; Anaphylaxis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Histamine Agents; Neurotransmitter Agents; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pharmacologic Actions; Chemical Actions and Uses; Hydrocarbons; Hydrocarbons, Cyclic; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Amines; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Catechols; Phenols; Benzene Derivatives; Alcohols; Pregnadienetriols; Amino Alcohols; Ethanolamines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Indenes; Prednisolone; Betamethasone; Epinephrine; Histamine Antagonists; levocetirizine; Dimethindene
• Other Study ID Numbers: BASEC-2025-00320; HumRes67580 (Registry Identifier: Humanforschung Schweiz); SNCTP000006696 (Registry Identifier: Humanforschung Schweiz)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No