Allergy;FoodNCT04329078
Relevance of Sensitization to Legumes in Children Allergic to Peanut
An observational study of Allergy;Food, run by Central Hospital, Nancy, France.
Trial summary
The objectives of this study are to determine in children allergic to peanut (i) the prevalence of sensitization to other legumes, (ii) the prevalence of allergy to each legume in patients who are sensitized to it (iii ) the severity of the allergy to legumes other than peanut Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Allergy;Food
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2020to 30 Jun 2020
- 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 18 years
- All sexes
- Child, Adult
Study population: children allergic to peanut with a follow-up at the Pediatric Allergy Department of the University Hospital of Nancy from january 2017 to february 2020
Who may be able to join
- Confirmed allergy to peanut
Who cannot join
- no available information regarding sensitization and tolerance to legumes
About this study
The objectives of this study are to determine in children allergic to peanut (i) the prevalence of sensitization to other legumes, (ii) the prevalence of allergy to each legume in patients who are sensitized to it (iii ) the severity of the allergy to legumes other than peanut
Read the detailed description
Allergy to legumes is more and more frequent, especially in children allergic to peanut, with some severe reactions but little is known about cross-reactivity and clinical meanings of legumes sensitization in children allergic to peanut.
All children with a confirmed peanut allergy and followed at the University Hospital of Nancy between January 1st 2017 and February 29th 2020 will be included in order to evaluate the prevalence of sensitization and allergy to other legumes in this population.
In children allergic to peanut and to at least one other legume, we will evaluate the severity of the allergy and the sIgE profiles for peanut.
- Conditions
- Allergy;Food
- Keywords
- food allergy, peanut, legumes, sensitization
- Medical subject headings
- Food Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitization to legumes
skin and sIgE sensitization
Measured: 2017 to 2020
Secondary outcomes (2)
allergy to legumes
history of allergic reaction or oral food challenge
Measured: 2017 to 2020
severity of allergy to legumes
history of allergic reaction or oral food challenge
Measured: 2017 to 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start1 Apr 2020 (estimated)
- Primary completion31 May 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergy;FoodStudies 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329078
- Sponsor's protocol ID
- 2019PI247
- Status last verified
- Mar 2020
- First submitted
- 30 Mar 2020
- Last updated
- 1 Apr 2020
- 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 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relevance of Sensitization to Legumes in Children Allergic to Peanut
- ClinicalTrials.gov ID
- NCT04329078
- Acronym / sponsor ID
- 2019PI247
- Conditions
- Allergy;Food
- Keywords
- food allergy, peanut, legumes, sensitization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 31 May 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 1 Apr 2020 (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 objectives of this study are to determine in children allergic to peanut (i) the prevalence of sensitization to other legumes, (ii) the prevalence of allergy to each legume in patients who are sensitized to it (iii ) the severity of the allergy to legumes other than peanut
Detailed description
Allergy to legumes is more and more frequent, especially in children allergic to peanut, with some severe reactions but little is known about cross-reactivity and clinical meanings of legumes sensitization in children allergic to peanut.
All children with a confirmed peanut allergy and followed at the University Hospital of Nancy between January 1st 2017 and February 29th 2020 will be included in order to evaluate the prevalence of sensitization and allergy to other legumes in this population.
In children allergic to peanut and to at least one other legume, we will evaluate the severity of the allergy and the sIgE profiles for peanut.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- children allergic to peanut with a follow-up at the Pediatric Allergy Department of the University Hospital of Nancy from january 2017 to february 2020
Key inclusion criteria (1 listed)
- Confirmed allergy to peanut
Key exclusion criteria (1 listed)
- no available information regarding sensitization and tolerance to legumes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
sensitization to legumes
Time frame: 2017 to 2020
skin and sIgE sensitization
2 secondary outcomes
allergy to legumes
Time frame: 2017 to 2020
severity of allergy to legumes
Time frame: 2017 to 2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergy;Food, run by Central Hospital, Nancy, 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 1 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 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitization to legumes (time frame: 2017 to 2020). 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 1 Apr 2020.