Sensitization to LegumesLégumineusesNCT03686891
Prevalence of Sensitization to Legumes in a Region From Southern France (Légumineuses)
A study testing Skin prick tests with four native legumes in people with Sensitization to Legumes, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The Mediterranean diet is a model for health. Indeed, according to some epidemiological studies, it would participate in the prevention of various diseases such as cardiovascular diseases, diabetes type 2, cancer and obesity. Among the foods composing the Mediterranean diet, wheat and legumes are strongly represented. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Sensitization to Legumes
- What is being tested?
- Skin prick tests with four native legumes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jan 2018to 16 Sep 2022
- Phase
- Interventional
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients seen in allergy consultation
- The patient (or parents for the under 18 years) must have given their free consent and signed the consent chart
- Men and women are included
- The patient is at least 2 years old
Who cannot join
- The patient is pregnant
- The patient is breast-feeding
- The patient is unable to stop in antihistamine medication for at least 7 days
- The patient refused or is unable to sign the consent chart
- The patient has a dermographism
Trial locations and contacts
1 site in 1 country.
France1 site
Service Exploration des allergologies-Hopital Arnaud de Villeneuve-CHU de Montpellier
Montpellier, 34295
About this study
Official title: Analyis of the Prevalence of Sensitization to Legumes by Realistic Skin Prick Tests in a Patient Population Consulting at the University Hospital of Montpellier
The Mediterranean diet is a model for health. Indeed, according to some epidemiological studies, it would participate in the prevention of various diseases such as cardiovascular diseases, diabetes type 2, cancer and obesity. Among the foods composing the Mediterranean diet, wheat and legumes are strongly represented. The introduction of legumes into an easily prepared and economical food for a large part of the population will lead to an increase in consumption. The combination of durum wheat semolina and legume flour would benefit from the nutritional qualities of the two raw materials (high protein, slow digestible carbohydrates, fiber, vitamins and minerals), but also of their double wheat-legume allergenicity.
- Conditions
- Sensitization to Legumes
- Being tested
- Skin prick tests with four native legumes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin prick tests with four native legumesOther
Skin prick tests with four native legumes
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Skin prick tests with four native legumes Receives: Other: Skin prick tests with four native legumes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitization rate to four cooked legumes in the population consulting in Allergy Unit at the University Hospital of Montpellier
A prick test will be considered as positive in the presence of a wheal of urticaria of at least 3 mm in size
Measured: 10 minutes (the average duration of the test will not be significantly increased)
Secondary outcomes (2)
Describe the population with positive skin prick tests to legumes
A prick test will be considered as positive in the presence of a wheal of urticaria of at least 3 mm in size
Measured: 5 years
Associations between symptoms on ingestion of these legumes
Association between the positivity of the legume prick test and (1) symptoms upon ingestion of legumes (e.g., aracid and other fruits and vegetables), (2) symptoms of rhinitis, asthma, atopic eczema, and (3) positivity to other prick tests of the standard pneumallergen battery
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start24 Jan 2018
- Primary completion16 Sep 2022
- Study completion16 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensitization to LegumesStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686891
- Sponsor's protocol ID
- 9776
- Acronym
- Légumineuses
- Status last verified
- Oct 2022
- First submitted
- 25 Sep 2018
- Last updated
- 17 Oct 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 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analyis of the Prevalence of Sensitization to Legumes by Realistic Skin Prick Tests in a Patient Population Consulting at the University Hospital of Montpellier
- ClinicalTrials.gov ID
- NCT03686891
- Acronym / sponsor ID
- Légumineuses / 9776
- Conditions
- Sensitization to Legumes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 24 Jan 2018 (actual)
- Primary completion
- 16 Sep 2022 (actual)
- Study completion
- 16 Sep 2022 (actual)
- First posted
- 27 Sep 2018 (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 Mediterranean diet is a model for health. Indeed, according to some epidemiological studies, it would participate in the prevention of various diseases such as cardiovascular diseases, diabetes type 2, cancer and obesity. Among the foods composing the Mediterranean diet, wheat and legumes are strongly represented. The introduction of legumes into an easily prepared and economical food for a large part of the population will lead to an increase in consumption. The combination of durum wheat semolina and legume flour would benefit from the nutritional qualities of the two raw materials (high protein, slow digestible carbohydrates, fiber, vitamins and minerals), but also of their double wheat-legume allergenicity.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Skin prick tests with four native legumesSkin prick tests with four native legumes |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients seen in allergy consultation
- The patient (or parents for the under 18 years) must have given their free consent and signed the consent chart
- Men and women are included
- The patient is at least 2 years old
Key exclusion criteria (5 listed)
- The patient is pregnant
- The patient is breast-feeding
- The patient is unable to stop in antihistamine medication for at least 7 days
- The patient refused or is unable to sign the consent chart
- The patient has a dermographism
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 |
|---|---|---|
| Skin prick tests with four native legumesSkin prick tests with four native legumes | Other | Experimental |
Primary outcome
Sensitization rate to four cooked legumes in the population consulting in Allergy Unit at the University Hospital of Montpellier
Time frame: 10 minutes (the average duration of the test will not be significantly increased)
A prick test will be considered as positive in the presence of a wheal of urticaria of at least 3 mm in size
2 secondary outcomes
Describe the population with positive skin prick tests to legumes
Time frame: 5 years
Associations between symptoms on ingestion of these legumes
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin prick tests with four native legumes in people with Sensitization to Legumes, run by University Hospital, Montpellier 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 17 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 rate to four cooked legumes in the population consulting in Allergy Unit at the University Hospital of Montpellier (time frame: 10 minutes (the average duration of the test will not be significantly increased)). 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 17 Oct 2022.