Actively Recruiting

Phase 4
Age: 6Months - 18Years
All Genders
ID07341776

Evaluation of Emergency Medication in Children With Food Allergies: Comparing Antihistamines Alone Versus Antihistamines Plus Steroids During Oral Food Challenges

Led by Johannes Trueck · Updated on 2026-01-27

160

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

J

Johannes Trueck

Lead Sponsor

U

University Children's Hospital Basel

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating whether steroids are necessary in treating allergic reactions to foods in children with suspected or confirmed IgE-mediated food allergies. The study compares two groups during an oral food challenge: one receiving oral antihistamines plus systemic corticosteroids, and the other receiving only oral antihistamines. The study aims to understand if adding steroids improves recovery from allergic reactions in this controlled clinical setting. Participants will be randomly assigned to receive either antihistamines with steroids or antihistamines alone if an allergic reaction occurs during the food challenge. Intramuscular adrenaline may be given as needed for severe reactions. The study is conducted during scheduled clinic visits for the oral food challenge, with no additional visits required. The medication is taken orally, and emergency treatments are provided according to clinical indications. During the study, doctors will closely monitor allergic symptoms from onset until full resolution, assessing up to 24 hours after the reaction. They will record the time to symptom resolution, medication doses used, reaction severity, hospital admission if any, and late-phase reactions. Participants will not need extra tests beyond the food challenge, and no long-term follow-up visits are required. The total observation period lasts up to 24 hours following the allergic reaction onset.

CONDITIONS

Brief Title

Steroid Use in Treatment of Allergic Reactions to Food

Who Can Participate

Age: 6Months - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Suspected or confirmed IgE-mediated food allergy
  • Age between 6 months and 18 years
Not Eligible

You will not qualify if you...

  • Non-IgE mediated food allergies
  • Non-food allergies
  • Age outside the specified range
  • Contraindications for oral food challenge or oral steroid use within one week before the challenge

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Up to 24 hours from onset of allergic symptoms

Participants undergo an oral food challenge during which they receive oral antihistamines with or without oral systemic corticosteroids to treat allergic reactions. Intramuscular adrenaline may be given as rescue medication if needed.

1 oral food challenge visit (in-person) with observation period

Trial Site Locations

Total: 2 locations

1

University Children's Hospital Basel

Basel, Basel, Switzerland, 4031

Actively Recruiting

2

University Children's Hospital, Zürich

Zurich, Canton of Zurich, Switzerland, 8008

Actively Recruiting

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Research Team

J

Johannes Trück, PD Dr. med. DPhil

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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