Relevance of Sensitization to Fenugreek in Children

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

Study Overview

• Status: Not yet recruiting
• Conditions: Allergy to Fenugreek
• Intervention / Treatment: Diagnostic test: Oral Food Challenge

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Amandine Divaret-Chauveau, MD; Phone Number: +33 630094606; Email: a.chauveau@chru-nancy.fr
• Study Contact Backup: Name: Timé Muller, MD; Phone Number: +33 630336839; Email: t.muller@chru-nancy.fr

Study Locations

• France
  • Vandœuvre-lès-Nancy, France, 54511
    • Centre Hospitalo-Universitaire de Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

children aged from 1 to 17 years old, sensitized to fenugreek with an evaluation of their tolerance to fenugreek by an oral food challenge

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Amandine Divaret-Chauveau, MD, Centre Hospitalo-Universitaire de Nancy

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2022
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: April 8, 2022
• First Submitted That Met QC Criteria: April 15, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 15, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: children; diagnostic; sensitization; allergy; legumes
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: 2021PI211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No