Peanut Allergy Clinical Trial
— PeaNewTOfficial title:
Reactive Doses and Times During Oral Food Challenge (OFC) to Peanut
Verified date | September 2018 |
Source | University Hospital, Montpellier |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | University hospital of Montpellier | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
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 |
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