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

NCT03680066 | Terminated DMC

• 1 other identifier: CCER 2017-01413
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Allergy; Peanut Allergy; Tree Nut Allergy

Keywords

Peanut allergy; Tree Nut allergy; Precautionary allergen labeling; May contain traces; Allergen threshold

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• Severity 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

Study Arms (1)

Foods with traces

EXPERIMENTAL

Oral food challenge with foods with traces

Other: Oral food challenge to foods with traces

Interventions

Oral food challenge to foods with traces OTHER

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.

Foods with traces

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Pediatric Allergy Unit - University Hospitals of Geneva

Geneva, 1205, Switzerland

Location

MeSH Terms

Conditions

Food Hypersensitivity; Peanut Hypersensitivity; Nut Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Nut and Peanut Hypersensitivity

Study Officials

• Philippe Eigenmann, MD

  University Hospitals of Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Pediatric Allergy Unit, Department of Pediatrics

Study Record Dates

• First Submitted: July 25, 2018
• First Posted: September 21, 2018
• Study Start: April 1, 2018
• Primary Completion: November 28, 2023
• Study Completion: November 28, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)