[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100518106":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":47,"responsibleParty":65,"collaborators":67,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":32,"enrollmentInfo":90,"targetDuration":32,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":105,"whyStopped":32,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"University Hospital Center of Martinique","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group","PLACEBO_COMPARATOR","The control group will receive daily a placebo capsule per os at mealtime (just before or after) for a period of 6 months",[13],"Other: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Experimental group","EXPERIMENTAL","The experimental group will receive daily per os one capsule of BioGaia® Gastrus probiotic (combination of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475) dosed at 108 colony forming units (CFU)\u002Fday (distributed by the laboratory PEDIACT France), taken at mealtime (just before or after) for a period of 6 months",[19],"Dietary Supplement: Limosilactobacillus reuteri",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Limosilactobacillus reuteri","The BioGaia® Gastrus probiotic capsule contains the following components: L. reuteri DSM 17938, L. reuteri ATCC PTA 6475) at 10\\^8 CFU\\*\u002Fday, fully hydrogenated palm oil; ascorbic acid; tangerine flavour and mint flavour.\n\n\\*Colony forming Unit",[15],[27],"BioGaïa® Gastrus",{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo","The placebo capsules have the same external appearance and composition as the BioGaia® Gastrus Limosilactobacillus reuteri probiotic capsule (combination of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475), but without the active ingredient.",[9],null,[34],{"name":35,"affiliation":36,"role":37},"DABOR RESIERE, Professor","University Hospital of Martinique","PRINCIPAL_INVESTIGATOR",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":32,"email":43},"SEBASTIEN CAVALINI","CONTACT","+596 596 592 696","sebastien.cavalini@chu-martinique.fr",{"name":45,"role":41,"phone":42,"phoneExt":32,"email":46},"CORINE CARPIN","corine.carpin@chu-martinique.fr",[48],{"facility":49,"status":32,"city":50,"state":51,"zip":52,"country":53,"countryCode":32,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Centre Hospitalier Universitaire de Martinique - Hôpital Pierre ZOBDA QUITMAN","Fort-de-France","France","97261","Martinique",{"type":55,"coordinates":56},"Point",[57,58],-61.07418,14.60365,{"lat":58,"lon":57},[61,62,63],{"name":40,"role":41,"phone":42,"phoneExt":32,"email":43},{"name":45,"role":41,"phone":42,"phoneExt":32,"email":46},{"name":64,"role":37,"phone":32,"phoneExt":32,"email":32},"Dabor RESIERE, Professor",{"type":66,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[68,71,73,76,78],{"name":69,"class":70},"BioGaia AB","INDUSTRY",{"name":72,"class":6},"University Hospital, Limoges",{"name":74,"class":75},"Regional Health Agency, Martinique","UNKNOWN",{"name":77,"class":75},"Biological Resource Centre, Martinique",{"name":79,"class":6},"Reims University hospital","100518106","effects-of-probiotic-oral-intake-on-plasma-chlordecone-kepone-concentrations-in-individuals-environmentally-exposed-to-pesticide-in-martinique-100518106",false,"NCT06026228","Effects of Probiotic Oral Intake on Plasma Chlordecone (Kepone) Concentrations in Individuals Environmentally Exposed to Pesticide in Martinique.","Effects of Oral Intake of the Probiotic Limosilactobacillus Reuteri on Plasma Chlordecone (Kepone) Concentrations (Chlordeconemia) in Individuals Environmentally Exposed to the Organochlorine Pesticide in Martinique : an Exploratory Pilot Study","CHLOR-DETOX","Inclusion Criteria:\n\n* Male or female, 18 years of age or older\n* Seen in clinical toxicology consultation at the CHU of Martinique during the study period\n* With an initial chlordeconemia \\> 1μg\u002FL on a test less than 1 month old at the time of study inclusion\n* Affiliated to a social security scheme\n* Having received informed information on research\n* Having freely given written and informed consent to participate in the research\n\nExclusion Criteria:\n\n* History of cancer\n* Recent infections less than 6 months old\n* Known digestive diseases: chronic diarrhoea, ulcerative colitis, Crohn's disease, pancreatitis\n* Digestive procedures less than 6 months old.\n* Intrahepatic cholestasis less than 6 months old\n* Extrahepatic cholestasis less than 6 months old\n* Use of cholestyramine or ursodeoxycholic acid in the previous 3 months\n* Consumption of food (non-ordinary yoghurt, etc.) or supplements (tablets, drops, capsules, etc.) containing L. reuteri or any other probiotic within the previous 2 weeks.\n* Antibiotics taken in the previous 4 weeks.\n* Immune deficiency secondary to a pathology (lymphoma, leukaemia) or medical treatment (immunosuppressant, corticoid, chemotherapy).\n* Women who are unable to obtain contraception during the trial\n* Persons referred to in articles L.1121-5, L.1121-7, L. 1121-8 of the Public Health Code:\n\n  * Pregnant woman, parturient or breastfeeding mother\n  * Adult subject to a legal protection measure (guardianship, curatorship, safeguard of justice)\n  * Persons deprived of their liberty by a judicial or administrative decision,\n  * Persons staying in a health or social care institution for purposes other than research\n* Persons subject to psychiatric care under Articles L. 3212-1 and L. 3213-1 of the Public Health Code.","ALL","18 Years",{"count":91,"type":92},100,"ESTIMATED","INTERVENTIONAL",[95],"NA","The CHLOR-DETOX study is a single-centre, double-blind, prospective, interventional, controlled, exploratory pilot study on subjects environmentally exposed to the organochlorine pesticide (kepone or chlordecone, CLD) in the French Caribbean (Martinique island). To our best knowledge, it is the first clinical trial in such subjects evaluating the potential effect of oral probiotic intake (Limosilactobacillus reuteri) on the reduction of CLD plasma levels (chlordeconemia) and fecal excretion, thus concurring to the reduction of CLD toxicity in study subjects.",[98],"Chlordecone (Kepone) Toxicity",[100,101,102,103,104],"Chlordecone toxicity","Probiotics","Gut elimination","entero-hepatic cycle","plasma level concentration","NOT_YET_RECRUITING","2024-02-19",{"date":108,"type":109},"2024-02-21","ACTUAL",{"date":111,"type":92},"2024-04",{"date":113,"type":92},"2026-10",{"name":5,"class":6},1]