Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Validation of the HYPONUT Product

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03849079
Recruitment Status : Terminated (All prick tests are positive)
First Posted : February 21, 2019
Last Update Posted : November 27, 2020
Information provided by (Responsible Party):
University Hospital, Montpellier

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.

Condition or disease Intervention/treatment Phase
Peanut Allergy Other: Hyponut Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Clinical Validation of the Inactivation Procedure for Peanut Major Allergens in the HYPONUT Product
Actual Study Start Date : September 24, 2019
Actual Primary Completion Date : February 4, 2020
Actual Study Completion Date : February 4, 2020

Arm Intervention/treatment
Experimental: Hyponut Other: Hyponut
Prick tests with hyponut

Primary Outcome Measures :
  1. Skin Prick Tests evaluation [ Time Frame: day patient enrolled ]

Secondary Outcome Measures :
  1. Oral food challenge evaluation [ Time Frame: day patient enrolled ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03849079

Layout table for location information
University Hospital
Montpellier, Hérault, France, 34090
Sponsors and Collaborators
University Hospital, Montpellier
Layout table for additonal information
Responsible Party: University Hospital, Montpellier Identifier: NCT03849079    
Other Study ID Numbers: UF 7542
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: November 27, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Peanut Allergy
Skin Prick Test
Oral Food Challenge
Additional relevant MeSH terms:
Layout table for MeSH terms
Peanut Hypersensitivity
Immune System Diseases
Nut and Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate