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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.
 
ClinicalTrials.gov Identifier: NCT03849079
Recruitment Status : Terminated (All prick tests are positive)
First Posted : February 21, 2019
Last Update Posted : November 27, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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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

Study Design
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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
Arms and Interventions
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Arm Intervention/treatment
Experimental: Hyponut Other: Hyponut
Prick tests with hyponut


Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03849079


Locations
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France
University Hospital
Montpellier, Hérault, France, 34090
Sponsors and Collaborators
University Hospital, Montpellier
More Information
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov 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

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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
Hyponut
Additional relevant MeSH terms:
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Peanut Hypersensitivity
Hypersensitivity
Immune System Diseases
 Nut and Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate