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Validation of the HYPONUT Product

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03849079
Enrollment
6
Registered
2019-02-21
Start date
2019-09-24
Completion date
2020-02-04
Last updated
2020-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peanut Allergy

Keywords

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

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.

Interventions

OTHERHyponut

Prick tests with hyponut

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Skin Prick Tests evaluationday patient enrolled

Secondary

MeasureTime frame
Oral food challenge evaluationday patient enrolled

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026