Assessing Tolerance to "May Contain Traces" Processed Foods in Tree Nuts or Peanut Allergic Children.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University Hospital, Geneva
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Result of the food challenges with foods labelled with "may contain traces" (tolerated or reacted).
Study Overview
Brief Summary
This protocol will help better define whether patients with peanut and/or tree nut food allergy can tolerate traces in products with precautionary allergen labelling.
Detailed Description
Visit 1 (V1): During this visit at the Pediatric Research Platform at the Children's Hospital, subjects will undergo an open food challenge to 3 processed foods labeled with "may contain traces" by following safety and accuracy guidelines for food challenges (7). The following foods (similar for all patients) will be given in one dose in the size of a regular serving:
- cookies, max 30 g;
- chocolate, max 30 g;
- breakfast cereals, max 50 g.
Each meal will be administered with a 1 hour observation period in between and at the end.
If the patient does not react to any of the foods or has only oral itching (mild symptoms), he/she will be instructed to stop the ban on "may contain" foods and eat them regularly. If the patient has more than mild symptoms, the study will be stopped and the patient will be banned from eating foods with traces. The study subjects with a negative challenge and instructed to eat foods with the "may contain" label will be provided emergency medications and instruction on when and how to use them according to current guidelines (8).
An age appropriate quality of life questionnaire will be filled out by the parents/patient during the visit.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Children aged 2-18 years at time of inclusion
- •Tree nut or peanut allergy documented by:
- •Positive skin prick tests (SPTs) to peanut and/or tree nuts
- •Positive specific IgE (sIgE) to peanut and/or tree nuts ( ≥0.35 kU/L)
- •A recent (< 1 year) positive food challenge, reacting to the dose of 30 mg of proteins or below.
- •Parent/Legal guardian has been informed about the study and has signed Informed Consent Form
Exclusion Criteria
- •History of a moderate or severe reaction during a food challenge with a dose of 30 mg of proteins or less.
- •Expected non-adherence to the study protocol.
- •Severe or uncontrolled asthma.
Arms & Interventions
Foods with traces
Oral food challenge with foods with traces
Intervention: Oral food challenge to foods with traces (Other)
Outcomes
Primary Outcomes
Result of the food challenges with foods labelled with "may contain traces" (tolerated or reacted).
Time Frame: At study entry
Result of the food challenges with foods labelled with "may contain traces" (tolerated or reacted).
Secondary Outcomes
- Tolerance to foods labelled with "may contain traces" eaten normally during a 3 months follow-up.(During 3 months follow-up)
- Frequency of reactions to foods labelled with "may contain traces" eaten normally during a 3 months follow-up.(During 3 months follow-up)
- Changes of quality of life after 3 months without restriction of foods labelled with "may contain traces", compared to baseline when restricting.(At entry and after 3 months)
- Severity of reactions to foods labelled with "may contain traces" eaten normally during a 3 months follow-up.(During 3 months follow-up)
Investigators
Philippe Eigenmann
Head, Pediatric Allergy Unit, Department of Pediatrics
University Hospital, Geneva