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OpenTrials
Completed

NCT Number: NCT03852342

Reactive Doses and Times During Oral Food Challenge 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.

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Key information

Conditions

Peanut Allergy Anaphylaxis Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nut and Peanut Hypersensitivity Peanut Hypersensitivity

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University hospital of Montpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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 outcomes

  1. Time between the reaction and the last administered dose

    Time frame: 1 day

    Time between the reaction and the last administered dose

  2. Identifying risk factors of peanut hypersensitivity

    Time frame: 1 day

    To identify the risk factors, that remain significantly associated with a positive peanut OFC

  3. Risk factors of anaphylaxis during a positive peanut OFC

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: PeaNewT

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 25, 2019
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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