Reactive Doses and Times During Oral Food Challenge to Peanut

NCT03852342 | Completed

• 1 other identifier: RECHMPL18_0344
• Study Type: observational
• Target: 262
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peanut Allergy

Keywords

Anaphylaxis; Oral Food Challenge; Hypersensitivity; Food Allergy; Peanut

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time between the reaction and the last administered dose

  1 day

• Identifying risk factors of peanut hypersensitivity

  1 day

• Risk factors of anaphylaxis during a positive peanut OFC

  1 day

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• The patient refused to participate in the study

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University hospital of Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Peanut Hypersensitivity; Anaphylaxis; Hypersensitivity; Food Hypersensitivity

Condition Hierarchy (Ancestors)

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

Study Officials

• Pascal DEMOLY, MD, PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: February 25, 2019
• Study Start: October 10, 2018
• Primary Completion: February 28, 2019
• Study Completion: March 20, 2019
• Last Updated: April 18, 2019

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)