Allergy to FenugreekNCT05340920
Relevance of Sensitization to Fenugreek in Children
An observational study of Allergy to Fenugreek, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Allergy to Fenugreek
- What is being tested?
- Oral Food Challenge
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2022to Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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
Who cannot join
- patient over 18 years old
- undeterminate oral food challenge
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalo-Universitaire de Nancy
Vandœuvre-lès-Nancy, 54511
About this study
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
- Conditions
- Allergy to Fenugreek
- Being tested
- Oral Food Challenge
- Keywords
- allergy, children, legumes, sensitization, diagnostic
- Medical subject headings
- Hypersensitivity, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Food ChallengeDiagnostic test
diagnostic values of skin prick test and specific IgE for allergy confirmed by oral food challenge (routine, not an intervention)
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2017-2022
skin prick-test to fenugreek
skin prick test positive if wheal size superior to 3mm
Measured: 2017-2022
specific IgE to fenugreek
specific IgE positive if value superior to 0.35kU/L
Measured: 2017-2022
Secondary outcomes (2)
severity of allergy
reactogenic dose (from 1 to 1000mg of fenugreek)
Measured: 2017-2022
molecular profile for peanut allergy
IgE values for rAra h1, h2, h3, h6, h8, h9
Measured: 2017-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study startApr 2022 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergy to FenugreekStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amandine DIVARET-CHAUVEAU, Central Hospital, Nancy, France
- Investigators
- Amandine Divaret-Chauveau, MD, Principal investigator, centre hospitalo-universitaire de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340920
- Sponsor's protocol ID
- 2021PI211
- Status last verified
- Apr 2022
- First submitted
- 8 Apr 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relevance of Sensitization to Fenugreek in Children
- ClinicalTrials.gov ID
- NCT05340920
- Acronym / sponsor ID
- 2021PI211
- Conditions
- Allergy to Fenugreek
- Keywords
- allergy, children, legumes, sensitization, diagnostic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- patient over 18 years old
- undeterminate oral food challenge
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Food Challengediagnostic values of skin prick test and specific IgE for allergy confirmed by oral food challenge (routine, not an intervention) | Diagnostic test | – |
Primary outcome
Oral food challenge to fenugreek
Time frame: 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
Time frame: 2017-2022
skin prick test positive if wheal size superior to 3mm
specific IgE to fenugreek
Time frame: 2017-2022
specific IgE positive if value superior to 0.35kU/L
2 secondary outcomes
severity of allergy
Time frame: 2017-2022
molecular profile for peanut allergy
Time frame: 2017-2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amandine Divaret-Chauveau, MD principal investigator
centre hospitalo-universitaire de Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergy to Fenugreek, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amandine Divaret-Chauveau, MD (+33 630094606, a.chauveau@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral food challenge to fenugreek (time frame: 2017-2022). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.