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Validation of the HYPONUT Product

NCT ID: NCT03849079

Last Updated: 2020-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-24

Study Completion Date

2020-02-04

Brief Summary

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The HYPONUT product was previously validated in a laboratory setting ("Procédé de préparation d'aliment hypoallergénique", n° FR1250977) on 2012. A international patent was then obtained on 2013. Through the present study, the investigators would like to prove that the hypoallergenicity of the product is sustained in a clinical setting. Patients allergic to peanuts currently undergo in vivo tests to confirm their allergy: skin prick tests, and oral food challenges. In vitro tests are also performed (i.e. IgE levels for peanut and peanut components). The follow-up of patients consists in regular yearly or semestral evaluations. During one of these evaluation, the investigators will skin tests patients with the hyponut product to verify if they are sensitized to this last one as well. When skin tests will be negative, the investigators will propose to patients to take some of the product to verify its tolerability as well.

Detailed Description

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Conditions

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Peanut Allergy

Keywords

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Peanut Allergy Skin Prick Test Oral Food Challenge Hyponut

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Hyponut

Group Type EXPERIMENTAL

Hyponut

Intervention Type OTHER

Prick tests with hyponut

Interventions

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Hyponut

Prick tests with hyponut

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients aged more than 6
* Patients suffering from peanut allergy and followed in the Allergy Unit of the University Hospital of Montpellier (France)

Exclusion Criteria

* Pregnancy, or patients breast-feeding
* Patients treated with drugs possibly altering the results of the tests (e.g. anti-histamines)
* Patients presenting with dermographism
* Patients not fluent in French
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital

Montpellier, Hérault, France

Site Status

Countries

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France

Other Identifiers

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UF 7542

Identifier Type: -

Identifier Source: org_study_id