Clinical and Biological Efficacy of Peanut Oral Immunotherapy

NCT02979600 | Completed DMC

• 1 other identifier: OBS-051
• Study Type: observational
• Target: 493
• Locations: 0 countries
• Sites: N/A

Brief Summary

An oral tolerance induction (OTI) protocol is conducted at the allergy Unit of Saint Vincent Hospital of Lille (France) in standard care since 2006. This protocol consists in exposing patients to regularly increasing doses of allergen. This protocol induces an increase of the threshold reactive dose (the minimum dose of allergen that triggered a reactive reaction) and a decrease of the quantity of specific immunoglobulin E (sIgE) against peanut proteins. The protocol is ended when the patient reaches a threshold reactive dose of 2942mg of peanut proteins, corresponding to 14 peanuts of middle size, which is the maximum dose of peanut that can be found in standard product in France. The investigators wish to study the evolution of the threshold reactive dose and of the sIgE of patients that have followed the OTI protocol. All the needed data are available in the medical records so the study will be conducted on retrospective data.

Conditions

Peanut Allergy

Keywords

Oral immunotherapy; Oral tolerance induction

Outcome Measures

Primary Outcomes (1)

• Evolution of the threshold reactive dose in milligrams

  During the OTI protocol, an oral food challenge is performed every 6 months. The dose that induce the first allergic reaction is reported. The protocol is followed until the patients get a threshold reactive dose of 2942mg of peanut protein, or until the patient decide to end it.

  At inclusion, then every 6 months until a threshold reactive dose of 2942mg of peanut protein is reached (up to 7 years)

Secondary Outcomes (1)

• Evolution of IgE dosages against Arah1, 2 and 3

  At inclusion, then every 6 months until a threshold reactive dose of 2942mg of peanut protein is reached (up to 7 years)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Peanut allergic patients that have followed a peanut oral tolerance induction protocol at the allergy Unit of Saint Vincent Hospital of Lille (France) since 2005

You may qualify if:

• Patients with clinical symptoms when consuming peanuts, such as urticaria, asthma, angioedema, atopic dermatitis, dermo-respiratory syndrome or anaphylactic shock.
• Positive sIgE against r Ara h 2 dosage, i.e. r Ara h 2 \>0.1
• Patients that had followed a peanut oral tolerance induction

You may not qualify if:

• No clinical symptoms or biological confirmation of a peanut allergy

Sponsors & Collaborators

• Lille Catholic University: lead

MeSH Terms

Conditions

Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

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

Study Officials

• Maxime Seynave, MD

  GHICL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: December 1, 2016
• Study Start: September 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 1, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share