[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535329":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":38,"centralContacts":43,"locations":49,"responsibleParty":71,"collaborators":75,"id":77,"slug":26,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":23,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":26,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":97,"overallStatus":100,"whyStopped":26,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Helsinki University Central Hospital","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","The participants will be given 4 capsules containing fecal matter (Capsule 1) after treatment with antibiotics on day 7. Intervention group will be given placebo (Capsules 2) on day 28.",[13,14,15],"Other: FMT","Other: Placebo","Drug: Amox Clav",{"label":17,"type":18,"description":19,"interventionNames":20},"Control","PLACEBO_COMPARATOR","The participants will be given 4 placebo capsules (Capsule 2) after treatment with antibiotics on day 7.\n\nControl group will be given FMT capsules (Capsules 1) as \"rescue therapy\" on day 28.",[13,14,15],[22,27,31],{"type":6,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"FMT","Capsulated oral auto fecal microbiota transplant",[17,9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","Capsulated hot chocolate powder",[17,9],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Amox Clav","5 day course of Amoxicillin Clavulanic acid given to all participants",[17,9],[37],"Amorion comp",[39],{"name":40,"affiliation":41,"role":42},"Otto Helve, Docent","University of Helsinki","STUDY_DIRECTOR",[44],{"name":45,"role":46,"phone":47,"phoneExt":26,"email":48},"Noora Carpén, MD","CONTACT","+358 9 4711","noora.carpen@hus.fi",[50],{"facility":51,"status":26,"city":52,"state":53,"zip":26,"country":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Helsinki University Hospital","Helsinki","Uusimaa","Finland",{"type":56,"coordinates":57},"Point",[58,59],24.93545,60.16952,{"lat":59,"lon":58},[62,64,67,69],{"name":63,"role":46,"phone":47,"phoneExt":26,"email":48},"Noora Carpén",{"name":65,"role":46,"phone":26,"phoneExt":26,"email":66},"Kaija-Leena Kolho, Professor","kaija-leena.kolho@hus.fi",{"name":65,"role":68,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"name":40,"role":70,"phone":26,"phoneExt":26,"email":26},"SUB_INVESTIGATOR",{"type":72,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Otto Helve","Docent",[76],{"name":41,"class":6},"100535329",false,"NCT06250413","Autoflor -Lyophilized Capsulated Autological FMT to Restore Gut Microbiome After Treatment With Antibiotics","Lyophilized Capsulated Autological Fecal Microbial Transplant to Restore Gut Microbiome After Treatment With Antibiotics","Inclusion Criteria:\n\n-previously healthy\n\nExclusion Criteria:\n\n* IBD (inflammatory bowel disease)\n* celiac disease\n* abdominal symptoms such as diarrhea or constipation necessitating medical therapy\n* pregnancy and breastfeeding\n* allergy towards antibiotics penicillins\n* allergy towards soya.\n* trehalose intolerance.\n* travelling outside of European Union during the last 3 months\n* use of antibiotics during the last 3 months\n* use of probiotics during the previous 2 weeks or during the study.",true,"ALL","18 Years","40 Years",{"count":88,"type":89},40,"ESTIMATED","INTERVENTIONAL",[92],"NA","In this clinical trial, our aim is to assess the effect of auto-FMT (Fecal microbiome transplantation) on the intestinal microbiota, after a course of antibiotics.\n\n30 healthy adults are recruited. All are given a five day course of amoxicillin-clavulanate. The subjects are double blinded and randomized to two groups. Group A is given autologous FMT (auto-FMT) on day 7 (two days after the end of the course of antibiotics) and Group B is given auto-FMT on day 28 (23 days after the end of the course of antibiotics).",[95,96],"Microbial Colonization","Antibiotic Side Effect",[23,98,99],"lyophilized","antibiotics","NOT_YET_RECRUITING","2024-02-13",{"date":103,"type":104},"2024-02-14","ACTUAL",{"date":106,"type":89},"2024-02",{"date":108,"type":89},"2027-12",{"name":73,"class":6},1]