Status:
ENROLLING_BY_INVITATION
Improved Diagnostics in Food Allergy Study
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Royal College of Surgeons, Ireland
University of Manchester
Conditions:
Food Allergy
Eligibility:
All Genders
2-18 years
Phase:
NA
Brief Summary
The investigators will conduct low-dose intranasal allergen challenges on children and young people with an indeterminate diagnosis of food allergy to cow's milk or peanut. Blood samples will also be ...
Eligibility Criteria
Inclusion
- IgE-sensitisation to peanut, (hen's) egg or cow's milk, with indeterminate clinical (allergy) status, defined as IgE-sensitisation below 95% positive predictive value (PPV) for diagnosis for either allergen-specific IgE or SPT, using published cut-offs OR clinician suspicion of tolerance (on basis of clinical history) despite IgE sensitisation \>95% PPV cut-offs.
- Written informed consent from parent/guardian, with assent from children aged 6 years and above wherever possible. Participants aged over 16 years will need to provide their own informed consent.
Exclusion
- Acute illness or current unstable asthma, defined as:
- Febrile ≥38.0oC in last 72 hours
- Acute wheeze in last 72 hours requiring treatment
- Recent admission to hospital in preceding 2 weeks for acute asthma
- Current medication
- Asthma reliever medication required in preceding 72 hours
- Recent administration of a medicine containing antihistamine within the last 3 days
- Current oral steroid for asthma exacerbation or course completed within last 2 weeks
- Unwilling or unable to fulfil study requirements
Key Trial Info
Start Date :
October 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2025
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT06097572
Start Date
October 18 2023
End Date
July 31 2025
Last Update
March 28 2024
Active Locations (2)
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1
Prof Jonathan Hourihane
Dublin, Ireland
2
Imperial College Healthcare NHS Trust (St. Mary's Hospital)
London, United Kingdom