[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100454050":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":39,"locations":45,"responsibleParty":62,"collaborators":26,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":26,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"University Hospital, Brest","OTHER",[8,16],{"label":9,"type":6,"description":10,"interventionNames":11},"Case","Patients aged to 1 to 3 years with severe asthma (i.e. resistant to inhaled corticosteroid doses less than or equal to 200μg fluticasone equivalent).\n\n\"Severe\" asthma patients (cases) are defined by poor asthma control under doses of inhaled corticosteroids ≤200μg fluticasone equivalent.",[12,13,14,15],"Procedure: Stool test","Procedure: Blood test","Procedure: Induced sputum","Procedure: nasale virology",{"label":17,"type":6,"description":18,"interventionNames":19},"Control","Patients aged to 1 to 3 years with low or moderate asthma (controlled with mild to moderate doses of inhaled corticosteroids less than or equal to 200μg of fluticasone equivalent).\n\n\"Mild to moderate\" asthma patients (controls) are defined by disease control by first-line treatment in asthma, i.e. corticosteroids inhaled at mild to moderate doses of ≤200 micrograms\u002Fday of fluticasone equivalent.",[12,13,14,15],[21,27,31,35],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Stool test","At inclusion (day 0), stools will be collected with a kit for to remove to 5 mg for each patient.",[9,17],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Blood test","Blood sample taken during inclusion (day 0) will be collected. There is between 19 and 26 mL for each patient.",[9,17],{"type":22,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"Induced sputum","At inclusion (day 0), bronchial aspiration after inhalation induction of 4 mL of 6% salt serum administered (after 200 μg of salbutamol via an inhalation chamber during a bronchial drainage session).",[9,17],{"type":22,"name":36,"description":37,"armGroupLabels":38,"otherNames":26},"nasale virology","At inclusion (Day 0), patients will be taken nasal swab for virology with swab adapted for nasal swab or with suction trap when blowing the child's nose (depending on center practice)and multiplex PCR.",[9,17],[40],{"name":41,"role":42,"phone":43,"phoneExt":26,"email":44},"Pierrick CROS","CONTACT","02 98 22 36 59","pierrick.cros@chu-brest.fr",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"CHU de Brest","RECRUITING","Brest","Finistère","29609","France","FR",{"type":55,"coordinates":56},"Point",[57,58],-4.48628,48.39029,{"lat":58,"lon":57},[61],{"name":41,"role":42,"phone":43,"phoneExt":26,"email":44},{"type":63,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100454050","respiratory-dysbiosis-in-preschool-children-with-asthma-predictive-of-a-severe-form-100454050",false,"NCT05192499","Respiratory Dysbiosis in Preschool Children with Asthma: Predictive of a Severe Form","DREAM","Inclusion Criteria:\n\n* Age greater than 1 year and less than 3 years\n* Diagnosis of asthma by a pediatrician\n* Parental consent\n* Affiliation to the social security system\n\nExclusion Criteria:\n\n* Chronic pathologies: congenital heart disease, immune deficiency, cystic fibrosis, bronchopulmonary dysplasia, encephalopathy, primary ciliary dyskinesia, laryngomalacia, digestive pathology requiring digestive surgery\n* Premature \\\u003C 34 SA\n* Recent antibiotic therapy (\\\u003C 7 days)\n* Treatment with oral corticosteroid therapy within the previous 10 days.\n* Patient whose parent(s) is (are) minor(s)","ALL","1 Year","3 Years",{"count":75,"type":76},30,"ESTIMATED","INTERVENTIONAL",[79],"NA","The prevalence of asthma in preschool children is between 11 and12%. Inhaled corticosteroid therapy is the main therapy used, however this treatment seems insufficiently effective in some children.\n\nRecent research in cystic fibrosis has made it possible to highlight pulmotypes corresponding to the different stages of pulmonary dysbiosis, and a predictive microbiological signature of an increased risk of early primocolonization to P. aeruginosa. These pulmotypes are the result of the so-called \"enterotyping\" analysis, a biostatistical method that makes it possible to stratify individuals according to the analysis of the microbiota. In the light of these data, it seems interesting to transcribe the concept of using a biomarker of the microbiota in the monitoring of a chronic lung disease such as asthma.\n\nThe hypothesis is that there is respiratory dysbiosis causing corticosteroid resistance to treatment in children under 3 years of age with severe asthma.",[82,83],"Asthma in Children","Dysbiosis",[85,86,87],"Paediatric Pulmonology","asthma","respiratory microbiome","2024-09-19",{"date":90,"type":91},"2024-09-23","ACTUAL",{"date":93,"type":91},"2022-02-04",{"date":95,"type":76},"2028-02-04",{"name":5,"class":6},1]