Nut AllergyREVIALLNCT02966938
Visual Recognition of Allergens by Allergic Patients and/or Their Parents
An observational study of Nut Allergy and Peanut Allergy, run by Lille Catholic University.
Trial summary
Food allergies are constantly increasing. Peanut and nut allergies are a major cause of allergic reactions. Diagnosed patients are also at risk, because 27% of the patients that had an allergic reaction have another one in the following year with the same food, despite a real improvement in industrial products… Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Nut Allergy, Peanut Allergy
- How many people
- 440 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Mar 2016
- 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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients and their family with peanut or other nuts allergies followed in the allergy Unit of Saint Vincent Hospital of Lille (France) from 2013 to 2015, that are following an elimination diet and beginning a therapeutic education.
Who may be able to join
- Peanut or nut allergy
- Following an elimination diet since at least 3 months
- Results obtained at the beginning of a therapeutic education started from 2013 to 2015
Who cannot join
- Patients opposed to enter the study
About this study
Food allergies are constantly increasing. Peanut and nut allergies are a major cause of allergic reactions. Diagnosed patients are also at risk, because 27% of the patients that had an allergic reaction have another one in the following year with the same food, despite a real improvement in industrial products labeling.
The investigators have observed in the allergy Unit that patients (and/or their family) following an elimination diet, sometimes since several years, use very strict elimination strategies. Those strategies sometimes lead to incapacities to recognize the allergens. Yet, a good identification of the allergen is the key to a successful elimination and the non-identification a known risk factor.
Read more
Ferdman shown in 2006 that 27% of the patients didn't recognize the allergen there were allergic to. However, this is a US study, and geographical specificities have an impact on food consumption and culture. Food allergology needs to take those two elements into account. For example, in France, a single food can have two names. It is the case of peanut, which can be called "arachide", or more frequently "cacahuète".
The goal of the study is to observe patient aptitudes to recognize peanut (and the association between the two names) and other nuts available in France and define by the European law, using a plate with various food samples in seed or in shell.
Thus, patients in care at the allergy Unit of Saint Vincent Hospital of Lille (France) and their families were surveyed with a standardized procedure at the beginning of their therapeutic education and their capacity to recognize various nuts, to identify peanut ("cacahuète" or "arachide") and to associate the two words "cacahuète" and "arachide" was assessed. It is a standard procedure in therapeutic education, and the responses have been systematically entered in the medical record.
The main objective of this study is to describe peanut or nut allergic patient capacity (adult, children and/or the family) to visually identify the foods there are allergic to.
The secondary objective of this study is to describe the capacity of patient that describe themselves as allergic to "arachide" to associate this word to the word "cacahuète".
- Conditions
- Nut Allergy, Peanut Allergy
- Medical subject headings
- Nut Hypersensitivity, Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Nut allergic patients | Allergic patient and their family with allergy to peanut or other tree nuts that are in elimination diet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient that can visually identify the foods there are allergic to.
Measured: At inclusion
Secondary outcomes (1)
number of patients presenting themselves as allergic to "arachide" knowing it is a synonym of "cacahuète"
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startDec 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nut AllergyStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Sauvage, MD, Principal investigator, GHICL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966938
- Sponsor's protocol ID
- OBS-048
- Acronym
- REVIALL
- Status last verified
- Nov 2016
- First submitted
- 15 Nov 2016
- Last updated
- 18 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Recognition of Allergens by Allergic Patients and/or Their Parents
- ClinicalTrials.gov ID
- NCT02966938
- Acronym / sponsor ID
- REVIALL / OBS-048
- Conditions
- Nut Allergy, Peanut Allergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 17 Nov 2016 (estimated)
- 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.
Food allergies are constantly increasing. Peanut and nut allergies are a major cause of allergic reactions. Diagnosed patients are also at risk, because 27% of the patients that had an allergic reaction have another one in the following year with the same food, despite a real improvement in industrial products labeling.
The investigators have observed in the allergy Unit that patients (and/or their family) following an elimination diet, sometimes since several years, use very strict elimination strategies. Those strategies sometimes lead to incapacities to recognize the allergens. Yet, a good identification of the allergen is the key to a successful elimination and the non-identification a known risk factor.
Ferdman shown in 2006 that 27% of the patients didn't recognize the allergen there were allergic to. However, this is a US study, and geographical specificities have an impact on food consumption and culture. Food allergology needs to take those two elements into account. For example, in France, a single food can have two names. It is the case of peanut, which can be called "arachide", or more frequently "cacahuète".
The goal of the study is to observe patient aptitudes to recognize peanut (and the association between the two names) and other nuts available in France and define by the European law, using a plate with various food samples in seed or in shell.
Thus, patients in care at the allergy Unit of Saint Vincent Hospital of Lille (France) and their families were surveyed with a standardized procedure at the beginning of their therapeutic education and their capacity to recognize various nuts, to identify peanut ("cacahuète" or "arachide") and to associate the two words "cacahuète" and "arachide" was assessed. It is a standard procedure in therapeutic education, and the responses have been systematically entered in the medical record.
The main objective of this study is to describe peanut or nut allergic patient capacity (adult, children and/or the family) to visually identify the foods there are allergic to.
The secondary objective of this study is to describe the capacity of patient that describe themselves as allergic to "arachide" to associate this word to the word "cacahuète".
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nut allergic patients | – | –Allergic patient and their family with allergy to peanut or other tree nuts that are in elimination diet. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients and their family with peanut or other nuts allergies followed in the allergy Unit of Saint Vincent Hospital of Lille (France) from 2013 to 2015, that are following an elimination diet and beginning a therapeutic education.
Key inclusion criteria (3 listed)
- Peanut or nut allergy
- Following an elimination diet since at least 3 months
- Results obtained at the beginning of a therapeutic education started from 2013 to 2015
Key exclusion criteria (1 listed)
- Patients opposed to enter the study
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
Number of patient that can visually identify the foods there are allergic to.
Time frame: At inclusion
1 secondary outcome
number of patients presenting themselves as allergic to "arachide" knowing it is a synonym of "cacahuète"
Time frame: at inclusion
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 18 Nov 2016.
- 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.
Christine Sauvage, MD principal investigator
GHICL
Questions about this trial
What is this clinical trial studying?
An observational study of Nut Allergy and Peanut Allergy, run by Lille Catholic University.
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 3 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: finished, as of the sponsor's last update on 18 Nov 2016. 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?
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?
Number of patient that can visually identify the foods there are allergic to. (time frame: At inclusion). 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 18 Nov 2016.