Steroid Use in Treatment of Allergic Reactions to Food
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age6-18
SponsorJohannes Trueck
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
suspected or confirmed IgE-mediated food allergy
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Antihistamines
DrugOral administration of antihistamines for treatment of allergic symptoms during the oral food challenge.
Systemic corticosteroids
DrugOral administration of systemic corticosteroids as adjunctive treatment of allergic reactions during the oral food challenge.
Adrenaline (rescue medication)
DrugIntramuscular administration of adrenaline as rescue treatment for severe allergic reactions (anaphylaxis), administered as clinically indicated.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Antihistamines plus oral steroidsActive comparator 3 interventions
Group B: Antihistamines only (no steroids)Active comparator 2 interventions
Trial outcomes
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.
Time frame
From onset of allergic symptoms during the oral food challenge until complete resolution of all allergic symptoms, assessed up to 24 hours.Secondary outcomes
1
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.2
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.3
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.4
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.Other outcomes
1
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.2
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.3
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.4
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).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Johannes Trueck
Lead sponsor
University Children's Hospital, Zurich
Sponsor institution
University Children's Hospital Basel
Collaborator
Source ClinicalTrials.gov