[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576953":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":43,"locations":53,"responsibleParty":137,"collaborators":139,"id":142,"slug":143,"hasResults":144,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":26,"eligibilityCriteria":148,"healthyVolunteers":144,"sex":149,"minAge":150,"maxAge":151,"enrollmentInfo":152,"targetDuration":26,"studyType":155,"phases":156,"briefSummary":158,"conditions":159,"keywords":165,"overallStatus":173,"whyStopped":26,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":183},{"fullName":5,"class":6},"Acibadem Maslak Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Routine Antibiotic Prophylaxis + Placebo","PLACEBO_COMPARATOR","This arm receives routine antibiotic prophylaxis with a single dose of intravenous Cefazolin and a placebo capsule to match the probiotic intervention.",[13],"Drug: Placebo Capsule",{"label":15,"type":16,"description":17,"interventionNames":18},"Routine Antibiotic Prophylaxis + Probiotics","EXPERIMENTAL","This arm receives routine antibiotic prophylaxis with a single dose of intravenous Cefazolin and a dual-strain probiotic containing Human Milk Oligosaccharides (HMO).",[19],"Dietary Supplement: Probiotic with Human Milk Oligosaccharides (HMO)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Placebo Capsule","Participants will receive an inert placebo capsule that matches the probiotic capsule in size, shape, and color. The placebo will be administered orally twice daily, starting 2 weeks before surgery and continuing for 2 weeks postoperatively.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DIETARY_SUPPLEMENT","Probiotic with Human Milk Oligosaccharides (HMO)","Participants will receive a dual-strain probiotic containing Human Milk Oligosaccharides (HMO) in capsule form. The probiotic will be administered orally twice daily, starting 2 weeks before surgery and continuing for 2 weeks postoperatively.",[15],[33],"Dual-Strain Probiotic",[35,39],{"name":36,"affiliation":37,"role":38},"Javad Parvizi, Prof. Dr.","International Joint Center Acibadem, Parvizi Surgical Innovation","STUDY_CHAIR",{"name":40,"affiliation":41,"role":42},"Emanuele Chisari, Dr., Ph.D.","Parvizi Surgical Innovation, University of Groningen","STUDY_DIRECTOR",[44,49],{"name":45,"role":46,"phone":47,"phoneExt":26,"email":48},"İbrahim Tuncay, Prof. Dr.","CONTACT","+90 212 304 43 78","ituncay@gmail.com",{"name":50,"role":46,"phone":51,"phoneExt":26,"email":52},"Göksel Dikmen, Assoc. Prof. Dr","+90 505 202 1748","goksel.dikmen@acibadem.com",[54,73,78,94,113,125],{"facility":55,"status":26,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Parvizi Surgical Innovation","Philadelphia","Pennsylvania","19107","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-75.16362,39.95238,{"lat":65,"lon":64},[68,72],{"name":69,"role":46,"phone":70,"phoneExt":26,"email":71},"Emanuele Chisari, Dr., Ph.D","+1 646 806 8067","chisari.emanuele@gmail.com",{"name":69,"role":46,"phone":26,"phoneExt":26,"email":26},{"facility":74,"status":26,"city":75,"state":26,"zip":76,"country":75,"countryCode":77,"cosmosGeoPoint":26,"geoPoint":26,"contacts":26},"Thonburi Trang Hastanesi","Thailand","40002","TH",{"facility":79,"status":26,"city":80,"state":26,"zip":81,"country":82,"countryCode":26,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Istanbul University Cerrahpasa","Istanbul","34098","Turkey (Türkiye)",{"type":62,"coordinates":84},[85,86],28.94966,41.01384,{"lat":86,"lon":85},[89,93],{"name":90,"role":46,"phone":91,"phoneExt":26,"email":92},"Halil İbrahim Bulut, Medical Student","+90 506 185 4819","halilibrahim.bulut@ogr.iuc.edu.tr",{"name":90,"role":46,"phone":26,"phoneExt":26,"email":26},{"facility":95,"status":26,"city":80,"state":26,"zip":96,"country":82,"countryCode":26,"cosmosGeoPoint":97,"geoPoint":99,"contacts":100},"Acıbadem International Joint Center","34457",{"type":62,"coordinates":98},[85,86],{"lat":86,"lon":85},[101,103,107,108,109,110,111],{"name":102,"role":46,"phone":51,"phoneExt":26,"email":52},"Göksel Dikmen, Assoc. Prof.",{"name":104,"role":46,"phone":105,"phoneExt":26,"email":106},"Vahit Emre Özden, Assoc. Prof.","+90 532 336 1464","emre.ozden@acibadem.com",{"name":45,"role":46,"phone":26,"phoneExt":26,"email":26},{"name":36,"role":46,"phone":26,"phoneExt":26,"email":26},{"name":102,"role":46,"phone":26,"phoneExt":26,"email":26},{"name":104,"role":46,"phone":26,"phoneExt":26,"email":26},{"name":112,"role":46,"phone":26,"phoneExt":26,"email":26},"Kayahan Karaytuğ, Assoc. Prof.",{"facility":114,"status":26,"city":80,"state":26,"zip":115,"country":82,"countryCode":26,"cosmosGeoPoint":116,"geoPoint":118,"contacts":119},"Acibadem LABMED Laboratories","34752",{"type":62,"coordinates":117},[85,86],{"lat":86,"lon":85},[120,124],{"name":121,"role":46,"phone":122,"phoneExt":26,"email":123},"Mustafa Serteser, Prof. Dr.","+90 539 515 3115","Mustafa.Serteser@acibadem.edu.tr",{"name":121,"role":46,"phone":26,"phoneExt":26,"email":26},{"facility":126,"status":26,"city":80,"state":26,"zip":115,"country":82,"countryCode":26,"cosmosGeoPoint":127,"geoPoint":129,"contacts":130},"Acıbadem Mehmet Ali Aydınlar University",{"type":62,"coordinates":128},[85,86],{"lat":86,"lon":85},[131,135],{"name":132,"role":46,"phone":133,"phoneExt":26,"email":134},"Arda Mavi, Intern Dr.","+90 537 852 6215","ardamavimd@gmail.com",{"name":136,"role":46,"phone":26,"phoneExt":26,"email":26},"Arda Mavi, Intern Dr",{"type":138,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[140],{"name":141,"class":6},"Acibadem University","100576953","phase-4-impact-of-probiotics-on-gut-microbiome-during-antibiotic-prophylaxis-in-elective-orthopedic-surgery-100576953",false,"NCT06791993","Impact of Probiotics on Gut Microbiome During Antibiotic Prophylaxis in Elective Orthopedic Surgery","Impact of Probiotics Combined with Antibiotic Prophylaxis on Gut Microbiome Balance in Patients Undergoing Elective Orthopedic Surgery, Double-Blinded Randomized Controlled Trial","Inclusion Criteria:\n\n* Adults aged between 18 and 65 years\n* Scheduled for elective low-risk orthopedic surgery (carpal tunnel release, A1 pulley release, knee arthroscopic surgery).\n\nExclusion Criteria:\n\n* History of infection or antibiotic use within the last 12 weeks.\n* Use of routine probiotics, vitamins, or herbal supplements in the last 4 weeks.\n* Known allergy to beta-lactam or cephalosporin antibiotics.\n* History of autoimmune disease, uncontrolled systemic disease, or chronic inflammatory conditions (e.g., systemic lupus erythematosus, rheumatoid arthritis).\n* History of chronic intestinal diseases such as small intestine bacterial overgrowth (SIBO), irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), or celiac disease.\n* Increased risk of infection due to medical comorbidities or use of immunosuppressive drugs.","ALL","18 Years","65 Years",{"count":153,"type":154},60,"ESTIMATED","INTERVENTIONAL",[157],"PHASE4","This study aims to evaluate whether probiotics can help maintain a healthy gut microbiome in patients receiving prophylactic antibiotics during elective orthopedic surgery. Antibiotics, while effective in preventing infections, can disrupt the balance of gut bacteria, leading to dysbiosis. The study hypothesizes that the use of probiotics during the perioperative period can prevent or reduce this disruption, supporting gut health and overall well-being. The research seeks to answer whether combining probiotics with routine antibiotic prophylaxis can preserve gut microbiome balance and improve patient outcomes.",[160,161,162,163,164],"Dysbiosis","Gut -microbiota","Microbiome Analysis","Probiotic","Antibiotic Prophylaxis",[166,167,168,169,164,170,171,172],"Gut Microbiome","Intestinal Dysbiosis","Surgical Site Infection","Probiotics","Human Milk Oligosaccharides (HMO)","Shotgun Metagenomic Sequencing","Short-Chain Fatty Acids (SCFAs)","NOT_YET_RECRUITING","2025-01-18",{"date":176,"type":177},"2025-01-24","ACTUAL",{"date":179,"type":154},"2025-02-01",{"date":181,"type":154},"2025-10-01",{"name":5,"class":6},6]