Validation of the HYPONUT Product

Peanut Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03849079
• Other study ID #: UF 7542
• Status: Terminated
• Phase: N/A
• Start date: September 24, 2019
• Est. completion date: February 4, 2020

Study information

• Verified date: November 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: February 4, 2020
• Est. primary completion date: February 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peanut Allergy
• Peanut Hypersensitivity

Intervention

Other:
• Hyponut
Prick tests with hyponut

Locations

Country	Name	City	State
France	University Hospital	Montpellier	Hérault

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin Prick Tests evaluation		day patient enrolled
Secondary	Oral food challenge evaluation		day patient enrolled