NCT05340920

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2022

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 22, 2022

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

April 22, 2022

Status Verified

April 1, 2022

Enrollment Period

1 month

First QC Date

April 8, 2022

Last Update Submit

April 15, 2022

Conditions

Keywords

allergychildrenlegumessensitizationdiagnostic

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • severity of allergy

    2017-2022

  • molecular profile for peanut allergy

    2017-2022

Interventions

Oral Food ChallengeDIAGNOSTIC_TEST

diagnostic values of skin prick test and specific IgE for allergy confirmed by oral food challenge (routine, not an intervention)

Eligibility Criteria

Age1 Year - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • patient over 18 years old
  • undeterminate oral food challenge

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalo-Universitaire de Nancy

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

HypersensitivityDisease

Condition Hierarchy (Ancestors)

Immune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Amandine Divaret-Chauveau, MD

    centre hospitalo-universitaire de Nancy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amandine Divaret-Chauveau, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of pediatric allergy department

Study Record Dates

First Submitted

April 8, 2022

First Posted

April 22, 2022

Study Start

April 1, 2022

Primary Completion

May 1, 2022

Study Completion

June 1, 2022

Last Updated

April 22, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations