Food Allergy Proved Clinical Trial
— AAAliOfficial title:
Association Between Asthma and Food Allergy in Children and Adults
| Verified date | August 2016 |
| Source | University Hospital, Montpellier |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Prevalences of food allergies and asthma increased in the population during the last decades.
These two pathologies, responsible for a real burden, are often associated and are to be
considered as comorbidities; this aspect is more and more studied in the literature and many
authors tried to find a link between diets and asthma. The narrow link between these two
atopic pathologies and the fact that food allergy can come along with respiratory symptoms
also in patients without history of asthma must be better understood, considered into the
management of food allergy. The main objective of this study is to study the prevalence of
signs and/or symptoms suggestive of bronchial hyperreactivity, during an oral food challenge
(OFC) in patients older than 5 years. The secondary objective is to study the risk factors to
develop asthma during a food allergy reaction.
This historical-prospective single center study , was realized in the Allergy Unit of the
University Hospital of Montpellier. All the patients having been hospitalized for a positive
OFC between January, 2001 and January, 2016 were included. The diagnosis of asthma was
established according to the recommended international clinical and physiological criteria.
Prevalence of bronchial hyperreactivity during OFC among those with positive OFC, was
calculated. The search for risk factors was made by a logistic regression univariate then
multivariate, completed by a decision tree.
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | March 2018 |
| Est. primary completion date | March 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 5 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Patient hospitalized for oral food challenge at the hospital Exclusion Criteria: - Patient want to leave the protocol - Patient take medication forbidden during the study |
| Country | Name | City | State |
|---|---|---|---|
| France | University hospital of Montpellier | Montpellier |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of patient with bronchospasm in OFC | up to 3 hours | ||
| Secondary | Questionnaire for the assessment of the responsible food of allergy | up to 3 hours | ||
| Secondary | the eliciting dose | the dose of the tested food which elicits the symptoms of allergy | up to 3 hours | |
| Secondary | The grade of the allergic reaction shown during the last food ingestion of the concerned food | up to 3 hours | ||
| Secondary | The presence of one or several sensitisations associated with respiratory allergens | defining the atopic ground | up to 3 hours | |
| Secondary | The level of specific immunoglobulin E of the concerned food | up to 3 hours | ||
| Secondary | The time of appearance of the first signs of atopy | up to 3 hours | ||
| Secondary | questionnaire for the assessment of the mode of clinical expression of food allergies | up to 3 hours |