Reactive Doses and Times During Oral Food Challenge to Peanut

Peanut Allergy Clinical Trial

— PeaNewT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03852342
• Other study ID #: RECHMPL18_0344
• Status: Completed
• Start date: October 10, 2018
• Est. completion date: March 20, 2019

Study information

• Verified date: September 2018
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: March 20, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peanut Allergy
• Peanut Hypersensitivity

Locations

Country	Name	City	State
France	University hospital of Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time between the reaction and the last administered dose	Time between the reaction and the last administered dose	1 day
Secondary	Identifying risk factors of peanut hypersensitivity	To identify the risk factors, that remain significantly associated with a positive peanut OFC	1 day
Secondary	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