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| ID | Type | Description | Link |
|---|---|---|---|
| HumRes67580 | Registry Identifier | Humanforschung Schweiz | |
| SNCTP000006696 | Registry Identifier | Humanforschung Schweiz |
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| Name | Class |
|---|---|
| University Children's Hospital Basel | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antihistamines | Drug | Oral administration of antihistamines for treatment of allergic symptoms during the oral food challenge. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 24 hours after onset of the allergic reaction. |
| Rebound allergic symptoms |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Johannes Trück, PD Dr. med. DPhil | Contact | +41 44 249 49 49 | johannes.trueck@kispi.uzh.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Children's Hospital Basel | Recruiting | Basel | Basel | 4031 | Switzerland |
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| ID | Term |
|---|---|
| D000707 | Anaphylaxis |
| D005512 | Food Hypersensitivity |
| ID | Term |
|---|---|
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D006633 | Histamine Antagonists |
| D004115 | Dimethindene |
| C472067 | levocetirizine |
| D001623 | Betamethasone |
| D011239 | Prednisolone |
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D018494 | Histamine Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
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|
| Systemic corticosteroids | Drug | Oral administration of systemic corticosteroids as adjunctive treatment of allergic reactions during the oral food challenge. |
|
|
| Adrenaline (rescue medication) | Drug | Intramuscular administration of adrenaline as rescue treatment for severe allergic reactions (anaphylaxis), administered as clinically indicated. |
|
|
| 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. | 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. | 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. | 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. | 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. | From resolution of initial allergic symptoms during the oral food challenge until 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. |
| 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. | 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. | 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. | 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. | 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. | Day of the oral food challenge (Day 0). |
| University Children's Hospital, Zürich | Recruiting | Zurich | Canton of Zurich | 8008 | Switzerland |
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| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D013259 | Steroids, Fluorinated |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |