Steroids for allergic reactions to food in children
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.
This study will test whether giving steroids in addition to adrenaline and antihistamines helps children who have allergic reactions during supervised food challenges.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 6 Months to 18 Years |
| Sex | All |
| Sponsor | University Children's Hospital, Zurich Academic / other |
| Locations | 2 sites (Basel, Basel and 1 other locations) |
| Trial ID | NCT07341776 on ClinicalTrials.gov |
What this trial studies
Children scheduled for a supervised oral food challenge who develop allergic reactions are randomly assigned to receive standard emergency medications with or without an added steroid. The randomization is done at the time of the reaction, and treating clinicians follow usual protocols including adrenaline and antihistamines as needed. Doctors closely monitor the course of the reaction and no extra visits or tests beyond routine care are required. The study is conducted at pediatric allergy centers in Basel and Zurich, Switzerland.
Who should consider this trial
Good fit: Children with suspected or confirmed IgE-mediated food allergies who are scheduled for a supervised oral food challenge and have no contraindications to steroid use or the challenge are ideal candidates.
Not a fit: Children with non-IgE or non-food allergies, those outside the eligible age range, or those with contraindications to oral food challenge or recent steroid use are unlikely to benefit from participation.
Why it matters
Potential benefit: If steroids are shown to be unnecessary, children could avoid an added medication and its side effects, and if they are helpful, treatment could be standardized to reduce prolonged or biphasic reactions.
How similar studies have performed: Steroids are commonly used in practice but randomized trial evidence for their benefit in acute food-allergic reactions is limited, so this approach is not well established.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Basel, Basel and 1 other locations
- University Children's Hospital Basel — Basel, Basel, Switzerland (Recruiting)
- University Children's Hospital, Zürich — Zurich, Canton of Zurich, Switzerland (Recruiting)
Study contacts
- Study coordinator: Johannes Trück, PD Dr. med. DPhil
- Email: johannes.trueck@kispi.uzh.ch
- Phone: +41 44 249 49 49
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.