Steroid Use in Treatment of Allergic Reactions to Food

NCT07341776 | Recruiting Phase 4

• 3 other identifiers: BASEC-2025-00320HumRes67580SNCTP000006696
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Total number of adrenaline doses and cumulative adrenaline dose

  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

  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

  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

  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

  From onset of allergic symptoms during the oral food challenge until patient discharge, assessed up to 24 hours.

Other Outcomes (7)

• Adverse events

  Up to 24 hours after onset of the allergic reaction.

• Rebound allergic symptoms

  Up to 24 hours after onset of the allergic reaction.

• Additional medical interventions

  Up to 24 hours after onset of the allergic reaction.

Study Arms (2)

Antihistamines plus oral steroids

ACTIVE COMPARATOR

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

Antihistamines only (no steroids)

ACTIVE COMPARATOR

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; Drug: Adrenaline (rescue medication)

Interventions

Systemic corticosteroids DRUG

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

Also known as: Betamethasone, Prednisolone

Antihistamines plus oral steroids

Adrenaline (rescue medication) DRUG

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

Also known as: Adrenaline

Antihistamines only (no steroids); Antihistamines plus oral steroids

Antihistamines DRUG

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

Also known as: Dimetindene maleate, Levocetirizine

Antihistamines only (no steroids); Antihistamines plus oral steroids

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• suspected or confirmed IgE-mediated food allergy

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Children's Hospital Basel: collaborator
• Johannes Trueck: lead

Study Sites (2)

University Children's Hospital Basel

Basel, Basel, 4031, Switzerland

RECRUITING

University Children's Hospital, Zürich

Zurich, Canton of Zurich, 8008, Switzerland

RECRUITING

MeSH Terms

Conditions

Anaphylaxis; Food Hypersensitivity

Interventions

Histamine Antagonists; Dimethindene; levocetirizine; Betamethasone; Prednisolone; Epinephrine

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Ethanolamines; Amino Alcohols; Alcohols; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives

Central Study Contacts

Johannes Trück, PD Dr. med. DPhil

CONTACT

+41 44 249 49 49; johannes.trueck@kispi.uzh.ch

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head, Division of Allergy

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: January 14, 2026
• Study Start: January 26, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

CH (2)