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NCT Number: NCT07341776

Steroid Use in Treatment of Allergic Reactions to Food

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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Key information

Conditions

Anaphylactic Reaction Allergy in Children Anaphylaxis Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate IgE Mediated Food Allergy Immune System Diseases

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Children's Hospital Basel, Basel, Switzerland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Antihistamines

Drug

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

Other names: Dimetindene maleate, Levocetirizine

Systemic corticosteroids

Drug

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

Other names: Betamethasone, Prednisolone

Adrenaline (rescue medication)

Drug

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

Other names: Adrenaline

Primary outcomes

  1. Time to complete resolution of allergic symptoms

    Time frame: From onset of allergic symptoms during the oral food challenge until complete resolution of all allergic symptoms, assessed up to 24 hours.

    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.

Secondary outcomes

  1. Total number of adrenaline doses and cumulative adrenaline dose

    Time frame: 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 intramuscular adrenaline administrations and cumulative adrenaline dose administered per participant for treatment of allergic reactions during the oral food challenge.

  2. Total number of antihistamine doses and cumulative antihistamine dose

    Time frame: 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 oral antihistamine administrations and cumulative antihistamine dose administered per participant for treatment of allergic reactions during the oral food challenge.

  3. Severity of allergic reaction

    Time frame: 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 reactions assessed using PRACTALL consensus definitions and documented on a standardized monitoring form during the oral food challenge.

  4. Hospitalization and intensive care unit admission

    Time frame: From onset of allergic reaction during the oral food challenge until hospital discharge or end of observation period, assessed up to 24 hours.

    Occurrence of hospitalization or admission to an intensive care unit (ICU) for management of allergic reactions occurring during the oral food challenge.

  5. Time from onset of allergic symptoms to patient discharge

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

    Time from onset of allergic symptoms leading to discontinuation of the oral food challenge until discharge from hospital or outpatient unit.

  6. Late-phase allergic reactions

    Time frame: From resolution of initial allergic symptoms during the oral food challenge until 24 hours after onset of the allergic reaction.

    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.

Other outcomes

  1. Adverse events

    Time frame: Up to 24 hours after onset of the allergic reaction.

    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.

  2. Rebound allergic symptoms

    Time frame: Up to 24 hours after onset of the allergic reaction.

    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.

  3. Additional medical interventions

    Time frame: Up to 24 hours after onset of the allergic reaction.

    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.

  4. Length of hospital stay and intensive care unit stay

    Time frame: Through hospital or ICU discharge (up to 24 hours after onset of the allergic reaction).

    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.

  5. Prolonged observation period after allergic reaction

    Time frame: Up to 24 hours after onset of the allergic reaction.

    Proportion of participants requiring extended clinical observation due to persistent or worsening symptoms after initial treatment during the oral food challenge.

  6. Patient and guardian assessment of symptom severity

    Time frame: Baseline and up to 24 hours after onset of the allergic reaction.

    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.

  7. Pollen exposure and weather conditions on the day of the oral food challenge

    Time frame: Day of the oral food challenge (Day 0).

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Johannes Trück, PD Dr. med. DPhil

CONTACT

[email protected]

+41 44 249 49 49

Sponsors and collaborators

Lead sponsor

Johannes Trueck

Other

Collaborators

  • University Children's Hospital Basel

Registry information

Official study title

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.

Acronym: SAFARI

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 14, 2026
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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