Reactive Doses and Times During Oral Food Challenge to Peanut

Completed

• Conditions: Peanut Allergy

• Registration Number: NCT03852342
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-09
• Study First Submitted: 2018-09-12
• Study Start: 2018-10-10
• Study First Submitted QC: 2019-02-20
• Study First Posted: 2019-02-25
• Primary Completion: 2019-02-28
• Study Completion: 2019-03-20
• Last Update Submitted: 2019-04-17
• Last Update Posted: 2019-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 262

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reactive doses of peanut (mg) at which an allergic reaction appears in patients with positive peanut Oral Food Challenge	1 day	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

Secondary Outcome Measures

Name	Time	Method
Identifying risk factors of peanut hypersensitivity	1 day	To identify the risk factors, that remain significantly associated with a positive peanut OFC
Time between the reaction and the last administered dose	1 day	Time between the reaction and the last administered dose
Risk factors of anaphylaxis during a positive peanut OFC	1 day	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.

Trial Locations

Locations (1)

University hospital of Montpellier; 🇫🇷 Montpellier, France