Study to Assess Tolerance of Traces in Peanut/Tree Nut Allergic Children.

Assessing Tolerance to "May Contain Traces" Processed Foods in Tree Nuts or Peanut Allergic Children.

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.

Study Overview

• Status: Terminated
• Conditions: Peanut Allergy; Food Allergy; Tree Nut Allergy
• Intervention / Treatment: Other: Oral food challenge to foods with traces

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.

For the following 3 months after "may contain food" challenges, the patients will be invited to eat on a regular basis any foods labeled as "may contain" tree nuts and/or peanuts and record the consumption on a diary. Such foods will only be eaten in presence of a family member instructed for the measures to be taken in case of a reaction. They will record any history of reaction and contact the study team. The brand name of the food, and if available the batch will be recorded. The participants will store the study food and its packaging safely in a box and bring it along at V2 for allergen content analysis.

If a reaction occurs, the food will be analyzed for allergen content by immunoaffinity capillary elecrophoresis-matrix assisted laser desorption/ionization mass spectrometry, as well as a simplified version of this technique, the immunomagnetic separation -matrix-assisted laser desorption/ionization mass spectrometry.

Visit 2 (V2): During this visit, the parents/patients will report on the brand, the frequency and the amount of "may contain" foods eaten since V1.

The quality of life questionnaire will be filled out again by the parents/patient.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1205
    • Pediatric Allergy Unit - University Hospitals of Geneva

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Foods with traces; Oral food challenge with foods with traces

Other: Oral food challenge to foods with traces; Subjects will undergo an open food challenge to 3 processed foods labeled with "may contain traces". 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Result of the food challenges with foods labelled with "may contain traces" (tolerated or reacted).	Result of the food challenges with foods labelled with "may contain traces" (tolerated or reacted).	At study entry

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerance to foods labelled with "may contain traces" eaten normally during a 3 months follow-up.	Tolerance to foods labelled with "may contain traces" eaten normally during a 3 months follow-up (reactions / no reactions to these foods).	During 3 months follow-up
Frequency of reactions to foods labelled with "may contain traces" eaten normally during a 3 months follow-up.	Frequency of reactions to foods labelled with "may contain traces" eaten normally during a 3 months follow-up (number of reactions).	During 3 months follow-up
Severity of reactions to foods labelled with "may contain traces" eaten normally during a 3 months follow-up.	Severity of reactions to foods labelled with "may contain traces" eaten normally during a 3 months follow-up (severity of reactions by reaction type).	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.	Changes of quality of life measured with the age-appropriate "Food allergy quality of life questionnaire (0-12 years [parents], 7-12 years [patients], or 13-17 years [patients]. Results (on a continuous numerical ranking from 1 to 6 for each item) after 3 months without restriction of foods labelled with "may contain traces", are compared to baseline when restricting.	At entry and after 3 months

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Investigators: Principal Investigator: Philippe Eigenmann, MD, University Hospitals of Geneva

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): November 28, 2023
• Study Completion (Actual): November 28, 2023

Study Registration Dates

• First Submitted: July 25, 2018
• First Submitted That Met QC Criteria: September 20, 2018
• First Posted (Actual): September 21, 2018

Study Record Updates

• Last Update Posted (Actual): December 5, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Peanut allergy; Tree Nut allergy; Precautionary allergen labeling; May contain traces; Allergen threshold
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Nut and Peanut Hypersensitivity; Hypersensitivity; Peanut Hypersensitivity; Food Hypersensitivity; Nut Hypersensitivity
• Other Study ID Numbers: CCER 2017-01413

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No