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Validation of the HYPONUT Product

Primary Purpose

Peanut Allergy

Status

Terminated

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Hyponut

About this trial

This is an interventional other trial for Peanut Allergy focused on measuring Peanut Allergy, Skin Prick Test, Oral Food Challenge, Hyponut

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hyponut

Arm Description

Outcomes

Primary Outcome Measures

Skin Prick Tests evaluation

Secondary Outcome Measures

Oral food challenge evaluation

Full Information

NCT ID

NCT03849079

First Posted

February 19, 2019

Last Updated

November 23, 2020

Sponsor

University Hospital, Montpellier

1. Study Identification

Unique Protocol Identification Number

NCT03849079

Brief Title

Validation of the HYPONUT Product

Official Title

Clinical Validation of the Inactivation Procedure for Peanut Major Allergens in the HYPONUT Product

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Terminated

Why Stopped

All prick tests are positive

Study Start Date

September 24, 2019 (Actual)

Primary Completion Date

February 4, 2020 (Actual)

Study Completion Date

February 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peanut Allergy

Keywords

Peanut Allergy, Skin Prick Test, Oral Food Challenge, Hyponut

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hyponut

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Hyponut

Intervention Description

Prick tests with hyponut

Primary Outcome Measure Information:

Title

Skin Prick Tests evaluation

Time Frame

day patient enrolled

Secondary Outcome Measure Information:

Title

Oral food challenge evaluation

Time Frame

day patient enrolled

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

University Hospital

City

Montpellier

State/Province

Hérault

ZIP/Postal Code

34090

Country

France

12. IPD Sharing Statement

Plan to Share IPD

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Validation of the HYPONUT Product

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