Reactive Doses and Times During Oral Food Challenge to Peanut (PeaNewT)

Reactive Doses and Times During Oral Food Challenge (OFC) to Peanut

Peanut allergy is a growing public health problem in developed countries with more and more hospitalizations for anaphylaxis. It has been determined that sensitization to certain peanut proteins such as rAra h 2, is predictive of allergy and could predict the severity of reaction (anaphylaxis) during Oral food challenges (OFC). So far, consensual threshold for cutaneous test and IgE as predictor in the positivity of OFC have not been determined. Identification of reactive doses for OFC and phenotype of patients would help to personalize management of patients subgroups, with an optimal security.

Study Overview

• Status: Completed
• Conditions: Peanut Allergy

• Study Type: Observational
• Enrollment (Actual): 262

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • University Hospital of Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients with a clinical suspicion of peanut allergy who underwent an open OFC to peanut between June 2001 to July 2018 in the Allergy Unit of the University Hospital of Montpellier (France).

Description

Inclusion criteria:

• Patients with a clinical suspicion of peanut allergy who underwent OFC to peanut
• Patients not objecting to participate in the study
• Men and women are included

Exclusion criteria:

• The patient refused to participate in the study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reactive doses of peanut (mg) at which an allergic reaction appears in patients with positive peanut Oral Food Challenge	An Oral Food Challenge consists in the ingestion of the suspected allergic food. The patient is given increased dose levels of this food throughout a day. The OFC is positive when the patient presents a clinical reaction (clinical symptoms linked to an allergic response) triggered by the food ingested. We'll gather the data of all patients who came in our unit of Allergology and who had a positive peanut OFC. The reactive dose is calculated from the total cumulative dose (mg) of peanut reached when the OFC peanut is considered positive. The reactive dose is considered as a time dependent data and will be analyzed with survival data analysis methods. The analyzed event is a positive OFC	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time between the reaction and the last administered dose	Time between the reaction and the last administered dose	1 day
Identifying risk factors of peanut hypersensitivity	To identify the risk factors, that remain significantly associated with a positive peanut OFC	1 day
Risk factors of anaphylaxis during a positive peanut OFC	To identify, among the collected data on the patient's clinical history detailled below, the risk factors of occurrence of an anaphylactic reaction during peanut OFC. Anaphylaxis is defined as a severe allergic reaction that appears quickly and has a fatal potential. It is usually characterized by the appearance of several signs and symptoms that can affect one or more systems of our body.	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Pascal DEMOLY, MD, PhD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2018
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): March 20, 2019

Study Registration Dates

• First Submitted: September 12, 2018
• First Submitted That Met QC Criteria: February 20, 2019
• First Posted (Actual): February 25, 2019

Study Record Updates

• Last Update Posted (Actual): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 17, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Hypersensitivity; Anaphylaxis; Oral Food Challenge; Peanut; Food Allergy
• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Nut and Peanut Hypersensitivity; Peanut Hypersensitivity
• Other Study ID Numbers: RECHMPL18_0344

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