A Phase 4 interventional study of Antihistamines and Systemic corticosteroids in Anaphylactic Reaction, Anaphylaxis and Allergy in Children, sponsored by Johannes Trueck. Recruiting at 2 sites in Switzerland. Open to participants aged 6 Months to 18 Years. Per ClinicalTrials.gov, last updated 2026-01-27.
Sponsored by Johannes Trueck · Phase 4, Interventional, and Treatment
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.
100 studies on the registry are indexed under Anaphylaxis; 20 are open to participants now.
This study's planned enrollment of 160 is above the median of 40 across 50 interventional studies indexed under Anaphylaxis.
Browse Anaphylaxis studies →This is the only study on the registry with Johannes Trueck as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
Oral administration of antihistamines for treatment of allergic symptoms during the oral food challenge.
Also known as: Dimetindene maleate, Levocetirizine
Oral administration of systemic corticosteroids as adjunctive treatment of allergic reactions during the oral food challenge.
Also known as: Betamethasone, Prednisolone
Intramuscular administration of adrenaline as rescue treatment for severe allergic reactions (anaphylaxis), administered as clinically indicated.
Also known as: Adrenaline
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.
Time frame: From onset of allergic symptoms during the oral food challenge until complete resolution of all allergic symptoms, assessed up to 24 hours.
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.
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 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.
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 reaction
Severity of allergic reactions assessed using PRACTALL consensus definitions and documented on a standardized monitoring form during the oral food challenge.
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.
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.
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.
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.
Time frame: 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.
Time frame: From resolution of initial allergic symptoms during the oral food challenge until 24 hours after onset of the allergic reaction.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day of the oral food challenge (Day 0).
Plan to share: Undecided
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