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Validation of the HYPONUT Product

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Terminated

Conditions

Peanut Allergy

Treatments

Other: Hyponut

Study type

Interventional

Funder types

Other

Identifiers

NCT03849079
UF 7542

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

6+ years old

Volunteers

No 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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

6 participants in 1 patient group

Hyponut
Experimental group
Treatment:
Other: Hyponut

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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