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

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ClinicalTrials.gov Identifier: NCT03680066
Recruitment Status : Recruiting
First Posted : September 21, 2018
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
Philippe Eigenmann, University Hospital, Geneva

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.

Condition or disease Intervention/treatment Phase
Food Allergy Peanut Allergy Tree Nut Allergy Other: Oral food challenge to foods with traces Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Assessing Tolerance to "May Contain Traces" Processed Foods in Tree Nuts or Peanut Allergic Children.
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

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.





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Tolerance to foods labelled with "may contain traces" eaten normally during a 3 months follow-up. [ Time Frame: During 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).

  2. Frequency of reactions to foods labelled with "may contain traces" eaten normally during a 3 months follow-up. [ Time Frame: During 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).

  3. Severity of reactions to foods labelled with "may contain traces" eaten normally during a 3 months follow-up. [ Time Frame: 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 on a severity scale).

  4. Changes of quality of life after 3 months without restriction of foods labelled with "may contain traces", compared to baseline when restricting. [ Time Frame: At entry and after 3 months ]
    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 scale 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.



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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03680066


Contacts
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Contact: François Graham, MD, MSc 079 55 35215 francois.graham@hcuge.ch

Locations
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Switzerland
Pediatric Allergy Unit - University Hospitals of Geneva Recruiting
Geneva, Switzerland, 1205
Contact: François Graham, MD, MSc       francois.graham@hcuge.ch   
Sponsors and Collaborators
University Hospital, Geneva
Investigators
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Principal Investigator: Philippe Eigenmann, MD University Hospitals of Geneva

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Responsible Party: Philippe Eigenmann, Head, Pediatric Allergy Unit, Department of Pediatrics, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT03680066     History of Changes
Other Study ID Numbers: CCER 2017-01413
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Philippe Eigenmann, University Hospital, Geneva:
Peanut allergy
Tree Nut allergy
Precautionary allergen labeling
May contain traces
Allergen threshold
Additional relevant MeSH terms:
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Hypersensitivity
Food Hypersensitivity
Peanut Hypersensitivity
Nut Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate
Nut and Peanut Hypersensitivity