Relevance of Sensitization to Fenugreek in Children

Sponsor

Central Hospital, Nancy, France (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05340920

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

24.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The prevalence of allergy to legumes is inscreasing, especially in children and for some of these legumes, little is known and there are not included in the list of priority allergen. The overall goal of this study is to improve knowledge about fenugreek allergy. The principal aim is to evaluate the prevalence of allergy to fenugreek confirmed by a positive oral food challenge in children sensitized to fenugreek. The secondary objectives are to describe the case of allergy to fenugreek (co-allergies, severity, age..), to evaluate diagnostic values of skin prick-tests and specific IgE and to compare the molecular profile of specific IgE to peanut between sensitization to fenugreek without allergy and sensitization with a confirmed allergy

Condition or Disease	Intervention/Treatment	Phase
Allergy to Fenugreek	Diagnostic Test: Oral Food Challenge

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Relevance of Sensitization to Fenugreek in Children

Anticipated Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Outcome Measures

Primary Outcome Measures

Oral food challenge to fenugreek [2017-2022]
Astier's score 0 to 4 (0=negative, 1 and 2=mild to moderate reaction, 3 and 4 = severe reaction)
skin prick-test to fenugreek [2017-2022]
skin prick test positive if wheal size superior to 3mm
specific IgE to fenugreek [2017-2022]
specific IgE positive if value superior to 0.35kU/L

Secondary Outcome Measures

severity of allergy [2017-2022]
reactogenic dose (from 1 to 1000mg of fenugreek)
molecular profile for peanut allergy [2017-2022]
IgE values for rAra h1, h2, h3, h6, h8, h9

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Children for whom an oral food challenge to fenugreek has been performed between the 1st January 2017 and the 15th April 2022 and for whom skin prick test and/or specific IgE to fenugreek are avalaible

Exclusion Criteria:

patient over 18 years old
undeterminate oral food challenge

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalo-Universitaire de Nancy	Vandœuvre-lès-Nancy		France	54511

Sponsors and Collaborators

Central Hospital, Nancy, France

Investigators

Principal Investigator: Amandine Divaret-Chauveau, MD, centre hospitalo-universitaire de Nancy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Amandine DIVARET-CHAUVEAU, Head of pediatric allergy department, Central Hospital, Nancy, France

ClinicalTrials.gov Identifier:

NCT05340920

Other Study ID Numbers:

2021PI211

First Posted:

Apr 22, 2022

Last Update Posted:

Apr 22, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Amandine DIVARET-CHAUVEAU, Head of pediatric allergy department, Central Hospital, Nancy, France

Additional relevant MeSH terms:

Hypersensitivity

Study Results

No Results Posted as of Apr 22, 2022