NCT02979600|CompletedDMC
Loading search results
Sponsor study identifier
observational
493
0 countries
N/A
Study Start
September 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2015
Actual (reported)Study Completion
December 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2015
Date type not reportedThis date has not been verified as actual or estimated.
December 2015
Actual (reported)December 2015
Actual (reported)November 17, 2016
Actual (reported)December 1, 2016
Actual (reported)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)
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)
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
Maxime Seynave, MD
GHICL
493 participants (actual enrollment reported by the registry).
First Submitted
November 17, 2016
First Posted
December 1, 2016
Study Start
September 2015
Date type not reportedThis date has not been verified as actual or estimated.
Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen OIT
Contact the study team to confirm eligibility.
Primary Completion
December 2015
Actual (reported)Study Completion
December 2015
Actual (reported)Last Updated
December 1, 2016
Record last verified: 2016-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: