Status:
COMPLETED
Improving the Safety of Oral Immunotherapy for Cow's Milk Allergy
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
JP Moulton Charitable Foundation
Sociedad Española de Alergología e Inmunología
Conditions:
Food Allergy
Eligibility:
All Genders
6-17 years
Phase:
NA
Brief Summary
Allergy to cow's milk is the most common food allergy affecting children. There is currently no accepted routine clinical therapy to cure milk allergy. Recently studies have attempted to induce desens...
Eligibility Criteria
Inclusion
- Allergic to 1.44g CM protein (approx. 40ml fresh milk) or less, at DBPCFC prior to randomisation
- Informed consent of parent/legal guardian, patient assent where possible
Exclusion
- Required previous admission to an intensive care unit for management of an allergic reaction.
- Significant symptoms of non---IgE---mediated CM allergy within the previous 12 months.
- Children with a past history of CM allergy currently consuming CM-containing products other than extensively--heated milk in baked foods (e.g. biscuits, cakes).
- Poorly controlled asthma within the previous 3 months (as defined by clinician judgement with reference to the ICON consensus), or asthma requiring treatment with \>5 days oral corticosteroids within the previous 3 months.
- Moderate---severe eczema, defined as requiring more than once daily application of 1% hydrocortisone as maintenance treatment despite appropriate use of emollients (eczema is not otherwise an exclusion criteria)
- Clinically significant chronic illness (other than asthma, rhinitis or eczema)
- History of symptoms of eosinophilic oesophagitis, irrespective of cause
- Undergoing specific immunotherapy to another allergen and within the first year of treatment.
- Receiving anti--IgE therapy, oral immunosuppressants, beta---blocker or ACE inhibitor.
- Pregnancy
- Unwilling or unable to fulfil study requirements
Key Trial Info
Start Date :
July 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 19 2022
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT02216175
Start Date
July 19 2018
End Date
January 19 2022
Last Update
January 18 2023
Active Locations (2)
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1
Niño Jesús Hospital
Madrid, Spain
2
Imperial College London / Imperial College Healthcare NHS Trust
London, United Kingdom