Status:
COMPLETED
Promoting Tolerance to Peanut in High-Risk Children
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Immune Tolerance Network (ITN)
Conditions:
Eczema
Egg Allergy
Eligibility:
All Genders
4-10 years
Phase:
PHASE2
Brief Summary
This study will evaluate whether early exposure to peanuts promotes tolerance and provides protection from developing peanut allergy in children who are allergic to eggs or who have severe eczema. Th...
Detailed Description
Allergic reactions to peanuts are potentially life-threatening and, in some children, can result from ingestion of only trace quantities of peanuts. At highest risk are children with eczema or who are...
Eligibility Criteria
Inclusion
- Able to consume solid food
- Allergy to eggs and/or severe eczema
- Informed consent obtained from parent or guardian.
Exclusion
- Clinically significant chronic illness. Participants with eczema or recurrent wheeze are not excluded.
- Positive skin prick test for peanut allergen with a wheel diameter greater than 4 mm in the presence of a negative saline control
- Previous or current consumption of peanut protein that exceeds 0.2 g of peanut protein on at least one occasion or 0.5 g over a single week
- Investigator-suspected allergy to peanut protein
- Investigator-suspected allergy to peanut protein in care provider or current household member.
- Diagnosis of persistent asthma
- ALT (SGPT) or bilirubin greater than 2 times the upper limit of age-related normal value
- BUN or creatinine greater than 1.25 times the upper limit of age-related normal value
- Platelet count less than 100,000/mL, hemoglobin less than 9 g/dL, or investigator-suspected immunocompromise
- Unwillingness or inability to comply with study requirements and procedures
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
640 Patients enrolled
Trial Details
Trial ID
NCT00329784
Start Date
December 1 2006
End Date
May 1 2014
Last Update
April 17 2019
Active Locations (1)
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1
Evelina Children's Hospital, Guy's & St Thomas' NHS Foundation Trust
London, England, United Kingdom, SE1 7EH