NCT03849079

Validation of the HYPONUT Product

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peanut Allergy

Interventions

Type	Name	Description
OTHER	Hyponut	Prick tests with hyponut

Timeline

• Start date: 2019-09-24
• Primary completion: 2020-02-04
• Completion: 2020-02-04
• First posted: 2019-02-21
• Last updated: 2020-11-27

Locations

1 site across 1 country: France