NCT03849079

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

September 24, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2020

Completed
Last Updated

November 27, 2020

Status Verified

November 1, 2020

Enrollment Period

4 months

First QC Date

February 19, 2019

Last Update Submit

November 23, 2020

Conditions

Peanut Allergy

Keywords

Peanut AllergySkin Prick TestOral Food ChallengeHyponut

Outcome Measures

Primary Outcomes (1)

  • Skin Prick Tests evaluation

    day patient enrolled

Secondary Outcomes (1)

  • Oral food challenge evaluation

    day patient enrolled

Study Arms (1)

Hyponut

EXPERIMENTAL
Other: Hyponut

Interventions

HyponutOTHER

Prick tests with hyponut

Hyponut

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged more than 6
  • Patients suffering from peanut allergy and followed in the Allergy Unit of the University Hospital of Montpellier (France)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Montpellier, Hérault, 34090, France

Location

MeSH Terms

Conditions

Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut HypersensitivityFood HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2019

First Posted

February 21, 2019

Study Start

September 24, 2019

Primary Completion

February 4, 2020

Study Completion

February 4, 2020

Last Updated

November 27, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)