NCT03048149

Brief Summary

This study is retrospective. It focuses on hazelnut allergic patients with a clinical history and a positive specific immunoglobulin E (sIgE) against hazelnut and its recombinants that have followed a hazelnut oral tolerance induction at the allergy Unit of Saint Vincent Hospital of Lille (France) since 2011.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2017

Completed
Last Updated

January 25, 2018

Status Verified

February 1, 2017

Enrollment Period

3 months

First QC Date

February 7, 2017

Last Update Submit

January 23, 2018

Conditions

Allergy

Keywords

hazelnut allergy

Outcome Measures

Primary Outcomes (1)

  • Evolution of the threshold reactive dose in milligrams

    During the OTI protocol, an oral food challenge is performed every 6 months. The dose that induce the first allergic reaction is reported. The protocol is followed until the patients get a threshold reactive dose of 11 766mg of hazelnut protein, or until the patient decide to end it.

    At inclusion, then every 6 months until a threshold reactive dose of 11 766mg of hazelnut protein is reached (up to 5 years)

Secondary Outcomes (2)

  • Evolution of IgE dosages against hazelnut proteins, r Cor a 1, 8, 9 or 14

    At inclusion, then every 6 months until a threshold reactive dose of 11 766mg of hazelnut protein is reached (up to 5 years)

  • Evolution of the size of the prick test

    At inclusion, then every 6 months until a threshold reactive dose of 11 766mg of hazelnut protein is reached (up to 5 years)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hazelnut allergic patients that have followed a hazelnut oral tolerance induction protocol at the allergy Unit of Saint Vincent Hospital of Lille (France) since 2011

You may qualify if:

  • Patients with clinical symptoms when consuming hazelnuts, such as urticaria, asthma, angioedema, atopic dermatitis, dermo-respiratory syndrome or anaphylactic shock.
  • Positive sIgE against hazelnut, r Cor a 1, 8, 9 or 14
  • Patients that had followed a hazelnut oral tolerance induction

You may not qualify if:

  • No clinical symptoms or biological confirmation of a hazelnut allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GHICL

Lomme, 59462, France

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Tomas Moraly

    GHICL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2017

First Posted

February 9, 2017

Study Start

December 1, 2016

Primary Completion

March 8, 2017

Study Completion

March 8, 2017

Last Updated

January 25, 2018

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)