[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523202":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":38,"locations":46,"responsibleParty":195,"collaborators":198,"id":202,"slug":203,"hasResults":204,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":204,"sex":210,"minAge":211,"maxAge":212,"enrollmentInfo":213,"targetDuration":26,"studyType":216,"phases":217,"briefSummary":219,"conditions":220,"keywords":222,"overallStatus":49,"whyStopped":26,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":237},{"fullName":5,"class":6},"University of Bari","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Interventional: Probiotics","EXPERIMENTAL","Patients will receive a four probiotic preparation (LactoLevure, UniPharma, Athens, Greece).) in capsules containing: Lactobacillus acidophilus LA-5 \\[1.75 × 109 colony-forming units (cfu)\\], Lactobacillus plantarum (0.5 × 109 cfu), Bifidobacterium lactis BB12 (1.75 × 109 cfu) and Saccharomyces boulardii (1.5 × 109 cfu).",[13],"Dietary Supplement: LactoLevure",{"label":15,"type":16,"description":17,"interventionNames":18},"Control: Placebo","PLACEBO_COMPARATOR","Patients will receive a placebo in capsules containing powdered glucose polymer.",[19],"Other: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","LactoLevure","Patients will receive two capsules, twice daily for 30 days, one through the nasogastric tube and one spread on the oropharynx. The probiotic capsules look identical to the placebo capsules; the powder will be similar when opened. The capsule for nasogastric tube will be opened and suspended in 100 ml of tap water. The capsule for the oropharynx will be opened and suspended in sterile water based surgical lubricant. The administration must happen at least 30 minutes after oral antiseptic product usage (e.g. daily chlorhexidine oral care), which otherwise might neutralize the study supplement's action.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","Patients will receive two capsules, twice daily for 30 days, one through the nasogastric tube and one spread on the oropharynx. The placebo capsules contain a powdered glucose polymer that is unharmful for the patient and will be provided by the sponsor. The placebo capsules look identical to the probiotic capsules; the powder will be similar when opened. The capsule for nasogastric tube will be opened and suspended in 100 ml of tap water. The capsule for the oropharynx will be opened and suspended in sterile water based surgical lubricant. The administration must happen at least 30 minutes after oral antiseptic product usage (e.g. daily chlorhexidine oral care), which otherwise might neutralize the study supplement's action.",[15],[32,35],{"name":33,"affiliation":5,"role":34},"Filomena Puntillo, MD, PhD","STUDY_DIRECTOR",{"name":36,"affiliation":5,"role":37},"Alberto Corriero, MD","PRINCIPAL_INVESTIGATOR",[39,43],{"name":36,"role":40,"phone":41,"phoneExt":26,"email":42},"CONTACT","+393280072443","alberto.corriero@gmail.com",{"name":33,"role":40,"phone":44,"phoneExt":26,"email":45},"+390805594237","filomena.puntillo@uniba.it",[47,68,87,107,120,136,153,168,182],{"facility":48,"status":49,"city":50,"state":26,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Hospital Erasme","RECRUITING","Brussels","Belgium","BE",{"type":54,"coordinates":55},"Point",[56,57],4.34878,50.85045,{"lat":57,"lon":56},[60,63,65],{"name":61,"role":40,"phone":26,"phoneExt":26,"email":62},"Prof Taccone, MD,PhD","Fabio.Taccone@ulb.be",{"name":64,"role":37,"phone":26,"phoneExt":26,"email":26},"Fabio Taccone, MD,PhD",{"name":66,"role":67,"phone":26,"phoneExt":26,"email":26},"Michele Salvagno, MD","SUB_INVESTIGATOR",{"facility":69,"status":49,"city":70,"state":71,"zip":26,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Regional General Hospital F. Miulli","Acquaviva delle Fonti","BA","Italy","IT",{"type":54,"coordinates":75},[76,77],16.8433,40.89704,{"lat":77,"lon":76},[80,84,85],{"name":81,"role":40,"phone":82,"phoneExt":26,"email":83},"Adalgisa Caracciolo, MD","+393495141839","a.caracciolo@miulli.it",{"name":81,"role":37,"phone":26,"phoneExt":26,"email":26},{"name":86,"role":37,"phone":26,"phoneExt":26,"email":26},"Giovanna Magnesa, MD",{"facility":88,"status":49,"city":89,"state":71,"zip":26,"country":72,"countryCode":73,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Intensive Care Unit, Policlinico di Bari","Bari",{"type":54,"coordinates":91},[92,93],16.86982,41.12066,{"lat":93,"lon":92},[96,97,99,100,101,103,105],{"name":36,"role":40,"phone":41,"phoneExt":26,"email":42},{"name":98,"role":37,"phone":26,"phoneExt":26,"email":26},"Mariateresa Giglio, MD",{"name":33,"role":37,"phone":26,"phoneExt":26,"email":26},{"name":36,"role":37,"phone":26,"phoneExt":26,"email":26},{"name":102,"role":37,"phone":26,"phoneExt":26,"email":26},"Luigi Pisani, MD, PhD",{"name":104,"role":37,"phone":26,"phoneExt":26,"email":26},"Rossana Soloperto, MD",{"name":106,"role":37,"phone":26,"phoneExt":26,"email":26},"Vito Marco Ranieri, MD, PhD",{"facility":108,"status":49,"city":109,"state":26,"zip":26,"country":72,"countryCode":73,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Azienda Ospedaliero Universitaria di Alessandria SS. Antonio e Biagio e Cesare Arrigo","Alessandria",{"type":54,"coordinates":111},[112,113],8.61007,44.90924,{"lat":113,"lon":112},[116],{"name":117,"role":40,"phone":118,"phoneExt":26,"email":119},"Gianmaria Cammarota","+39 347 5226578","gianmaria.cammarota@uniupo.it",{"facility":121,"status":49,"city":89,"state":26,"zip":122,"country":72,"countryCode":73,"cosmosGeoPoint":123,"geoPoint":125,"contacts":126},"Ospedale Di Venere","70131",{"type":54,"coordinates":124},[92,93],{"lat":93,"lon":92},[127,129,132,134],{"name":128,"role":40,"phone":26,"phoneExt":26,"email":26},"Claudio Petrillo, Dr",{"name":130,"role":40,"phone":26,"phoneExt":26,"email":131},"Nilo De Toma, Dr","nilodetoma@gmail.com",{"name":133,"role":37,"phone":26,"phoneExt":26,"email":26},"Nilo De Toma",{"name":135,"role":37,"phone":26,"phoneExt":26,"email":26},"Claudio Petrillo",{"facility":137,"status":49,"city":138,"state":26,"zip":26,"country":72,"countryCode":73,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"AUSL Bologna Ospedale Bellaria","Parma",{"type":54,"coordinates":140},[141,142],10.32618,44.79935,{"lat":142,"lon":141},[145,149,151],{"name":146,"role":40,"phone":147,"phoneExt":26,"email":148},"Manuel Moneti","+39 3920425452","manuel.moneti@ausl.bologna.it",{"name":150,"role":37,"phone":26,"phoneExt":26,"email":26},"Manuel Moneti, MD",{"name":152,"role":37,"phone":26,"phoneExt":26,"email":26},"Raffaele Aspide, MD, PhD",{"facility":154,"status":49,"city":138,"state":26,"zip":26,"country":72,"countryCode":73,"cosmosGeoPoint":155,"geoPoint":157,"contacts":158},"Azienda Ospedaliero Universitaria di Parma",{"type":54,"coordinates":156},[141,142],{"lat":142,"lon":141},[159,163,164,166],{"name":160,"role":40,"phone":161,"phoneExt":26,"email":162},"Edoardo Picetti","+39 347 884354","epicetti@ao.pr.it",{"name":160,"role":37,"phone":26,"phoneExt":26,"email":26},{"name":165,"role":67,"phone":26,"phoneExt":26,"email":26},"Susanna Biondini",{"name":167,"role":67,"phone":26,"phoneExt":26,"email":26},"Federica Garofalo",{"facility":169,"status":49,"city":170,"state":26,"zip":26,"country":72,"countryCode":73,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Azienda Ospedaliera di Perugia","Perugia",{"type":54,"coordinates":172},[173,174],12.38878,43.1122,{"lat":174,"lon":173},[177,181],{"name":178,"role":40,"phone":179,"phoneExt":26,"email":180},"Angelo Giacomucci Dr","+3923299321","angelo.giacomucci@ospedale.perugia.it",{"name":178,"role":37,"phone":26,"phoneExt":26,"email":26},{"facility":183,"status":49,"city":184,"state":26,"zip":26,"country":72,"countryCode":73,"cosmosGeoPoint":185,"geoPoint":189,"contacts":190},"Azienda ospedaliera Santa Maria di Terni","Terni",{"type":54,"coordinates":186},[187,188],12.64329,42.56335,{"lat":188,"lon":187},[191],{"name":192,"role":40,"phone":193,"phoneExt":26,"email":194},"Maria Laura Scarcella","+39 3474285936","m.scarcella@aospterni.it",{"type":37,"investigatorFullName":196,"investigatorTitle":197,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Filomena Puntillo","Professor",[199],{"name":200,"class":201},"Uni-Pharma","INDUSTRY","100523202","probiotics-to-actively-counter-ventilator-associated-pneumonia-proact-100523202",false,"NCT06092554","Probiotics to Actively Counter Ventilator Associated Pneumonia (PROACT)","Probiotics in ICU to Reduce Ventilator-Associated Pneumonia: A Double-blind Multicentre Randomized Clinical Trial","PROACT","Inclusion Criteria:\n\n* adults aged 18-80 years\n* at least one of the following conditions: a) recent trauma involving head injury and at least one more organ system; b) stroke or brain hemorrhage without any sign of aspiration and lung infection\n* intubation and start of mechanical ventilation. This needs to start immediately after the event described in the inclusion criteria (b). For cases of head trauma this is defined as start in the ambulance or the emergency department\n* likelihood that the duration of mechanical ventilation would be at least six days\n* written informed consent provided by the patient or legal representative\n\nExclusion Criteria:\n\n* has received mechanical ventilation more than 72 hours from start of screening\n* pregnancy or Lactation\n* patients at risk of iatrogenic probiotic infection e.g. immunosuppression which includes\n* HIV \\\u003C200 CD4 cells\u002FμL\n* those receiving chronic immunosuppressive medications (e.g., azathioprine, cyclosporine, cyclophosphamide, tacrolimus, methotrexate, mycofenolate, Anti-IL2)\n* previous transplantation at any time\n* malignancy requiring chemotherapy in the last 3 months\n* neutropenia \\[absolute neutrophil count \\\u003C 500\\])\n* patients with a primary diagnosis of severe pancreatitis (Ranson score of 3 or more). Mild and moderate pancreatis is not excluded\n* ischemic bowel disease\n* oropharyngeal mucosal injury\n* inability to receive enteral medications\n* intent to withdraw advanced life support as per ICU doctor in charge\n* patients at risk of endovascular infection which includes\n\n  1. previously documented rheumatic heart disease, congenital valve disease, surgically repaired congenital heart disease, unrepaired cyanotic congenital heart disease, any intracardiac repair with prosthetic material \\[mechanical or bioprosthetic cardiac valves\\]\n  2. previous or current endocarditis\n  3. permanent endovascular devices (e.g., endovascular grafts \\[e.g., aortic aneurysm repair, stents involving large arteries such as aorta, femorals and carotids\\] inferior vena cava filters, dialysis vascular grafts\n  4. tunnelled (not short-term) hemodialysis catheters\n  5. pacemakers or defibrillators\n\n     Patients with peripherally inserted central catheters (PICCs), temporary central venous catheters, central venous dialysis catheters, coronary artery stents, coronary artery bypass grafts (CABG), or neurovascular coils are not excluded, nor are patients with mitral valve prolapse or bicuspid aortic valve if they do not meet any other exclusion criteria.\n* patients with sepsis and\u002For septic shock","ALL","18 Years","80 Years",{"count":214,"type":215},186,"ESTIMATED","INTERVENTIONAL",[218],"NA","PROACT study aims to resolve uncertainties to influence actual practice guidelines or public health policing regarding VAP prevention in ICU by using probiotics administration.\n\nMulti-trauma patients with a head injury OR stroke or brain haemorrhage patients without any sign of aspiration and lung infection will be enrolled and randomized to either placebo or probiotic treatment to assess if VAP and mortality can be reduced in the interventional group.",[221],"Ventilator Associated Pneumonia",[221,223,224,225,226,227],"Traumatic Brain Injury","stroke","probiotics","VAP","TBI","2025-09-17",{"date":230,"type":231},"2025-09-23","ACTUAL",{"date":233,"type":231},"2023-12-13",{"date":235,"type":215},"2026-07-15",{"name":5,"class":6},9]