[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625397":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":43,"responsibleParty":59,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":25,"enrollmentInfo":75,"targetDuration":25,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":89,"overallStatus":90,"whyStopped":25,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Casa di Cura Dott. Pederzoli","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Clostridium butyricum CBM588","EXPERIMENTAL","Participants randomized to the experimental arm will receive Clostridium butyricum CBM588 (Butirrisan®) supplementation in addition to standard postoperative care following pancreaticoduodenectomy.",[13],"Other: Clostridium butyricum CBM588 Strain",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants randomized to the placebo arm will receive placebo tablets identical in appearance, packaging, and dosing schedule to the experimental product, in addition to standard postoperative care following pancreaticoduodenectomy.",[19],"Other: Placebo",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Clostridium butyricum CBM588 Strain","Butirrisan® contains ≥4.5 × 10⁵ CFU of Clostridium butyricum CBM588 per tablet. Participants will receive 6 tablets per day (3 tablets in the morning and 3 tablets in the evening) starting at hospital discharge and continuing for 3 months.",[9],null,{"type":6,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Placebo tablets contain lactose and inert components and will be administered at a dosage of 6 tablets per day (3 tablets in the morning and 3 tablets in the evening) starting at hospital discharge and continuing for 3 months.",[15],[30],{"name":31,"affiliation":32,"role":33},"Giovanni Butturini, MD, PhD","Ospedale Pederzoli","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Erica Pizzocaro, MSC","CONTACT","+390456449283","erica.pizzocaro@ospedalepederzoli.it",{"name":41,"role":37,"phone":25,"phoneExt":25,"email":42},"Alice Cattelani, MD","alice.cattelani@outlook.it",[44],{"facility":32,"status":25,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Peschiera del Garda","Verona","37019","Italy","IT",{"type":51,"coordinates":52},"Point",[53,54],10.68614,45.43912,{"lat":54,"lon":53},[57],{"name":31,"role":37,"phone":38,"phoneExt":25,"email":58},"giovanni.butturini@ospedalepederzoli.it",{"type":60,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[62],{"name":63,"class":64},"PharmExtracta S.p.A.","UNKNOWN","100625397","pan-clo-bu-pancreas-clostridium-butyricum-100625397",false,"NCT07422103","PAN-CLO-BU (PANcreas-CLOstridium-BUtyricum)","Supplementation With Clostridium Butyricum CBM588 in Patients Undergoing Pancreaticoduodenectomy for Periampullary Neoplasms: A Prospective Randomized Double-Blind Study","PAN-CLO-BU","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Written informed consent\n* Patients undergoing pancreaticoduodenectomy\n* Candidates for upfront surgery without previous neoadjuvant chemotherapy or radiotherapy\n* Patients with benign or malignant periampullary neoplasms\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Previous or current use of Clostridium butyricum CBM588\n* Lactose intolerance\n* Neoadjuvant chemotherapy or radiotherapy","ALL","18 Years",{"count":76,"type":77},158,"ESTIMATED","INTERVENTIONAL",[80],"NA","This is a prospective, randomized, double-blind, single-center clinical trial designed to evaluate the effects of Clostridium butyricum CBM588 supplementation on postoperative diarrhea, gastrointestinal symptoms, and quality of life in patients undergoing pancreaticoduodenectomy for periampullary neoplasms. Oncological outcomes, including disease-free survival and overall survival, will be monitored as secondary endpoints during follow-up.",[83,84,85,86,87,88],"Pancreatic Cancer","Pancreatic Diseases","Gastrointestinal Symptoms","Clostridium Butyricum Miyairi","Pancreatoduodenectomy","CBM588",[83,84,85,86],"NOT_YET_RECRUITING","2026-02-12",{"date":93,"type":94},"2026-02-19","ACTUAL",{"date":96,"type":77},"2026-03-15",{"date":98,"type":77},"2030-11-30",{"name":5,"class":6},1]