[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565492":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":44,"responsibleParty":64,"collaborators":26,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":26,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"University of Padova","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Prolife 10 Forte","ACTIVE_COMPARATOR","Treatment: 1 dose\u002Fdie (contains 10 ml with: in particular, 7 strains of Lactobacillus (L. casei R215, L. plantarum Lp-115, L. helveticus R0052, L. acidophilus La-14, L. gasseri Lg-36, L. brevis Lbr-35, L. rhamnosus HN001), 2 strains of Bifidobacteria (B. lactis Bl-04 and HN019) and Bacillus coagulans BC4. In addition, it contains 10 mg of glucoligosaccharide and a pool of Vitamin B (B1, B2, B6, B12).",[13],"Dietary Supplement: Prolife",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Treatment 1dose\u002Fdie ( All additional components except probiotics and vitamins)",[19],"Dietary Supplement: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Prolife","randomized in a 1:1 ratio to treatment :1 vial\u002Fday for 60 days.",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Placebo: 1 vial\u002Fday for 60 days.",[15],[31],{"name":32,"affiliation":5,"role":33},"Edoardo V Savarino","PRINCIPAL_INVESTIGATOR",[35,41],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Edoardo V. Savarino, Prof.MD; PhD","CONTACT","0498218720","0039","edoardo.savarino@unipd.it",{"name":42,"role":37,"phone":38,"phoneExt":39,"email":43},"Sonia Facchin, PhD","sonia.facchin@unipd.it",[45],{"facility":46,"status":47,"city":48,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Edoardo Vincenzo Savarino","RECRUITING","Padua","35128","Italy","IT",{"type":53,"coordinates":54},"Point",[55,56],11.88586,45.40797,{"lat":56,"lon":55},[59,62],{"name":60,"role":37,"phone":61,"phoneExt":26,"email":40},"Edoardo V. Savarino","+39.049.8217749",{"name":63,"role":37,"phone":26,"phoneExt":26,"email":43},"Sonia Facchin",{"type":33,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Savarino Edoardo Vincenzo","Prof","100565492","evaluation-of-prolife-10-forte-on-gut-microbiota-composition-in-uc-patients-100565492",false,"NCT06642883","Evaluation of ProLife 10 FORTE on Gut Microbiota Composition in UC Patients","Evaluation of the Effects of 10-strain Probiotic (ProLife 10 FORTE) on Gut Microbiota Composition in Patients Presenting with Ulcerative Colitis During the Remission Phase","ProZ-UC","Inclusion Criteria:\n\n* Diagnosis of UC confirmed by clinical, endoscopic, and histopathological evidence. Disease in remission phase confirmed by clinical, endoscopic, and histopathological evidence.\n* Age between 18 and 75 years old.\n* Ability of the subject to participate fully in all aspects of this clinical trial.\n\nExclusion Criteria:\n\n* Patients with active UC are determined by clinical, endoscopic, and histopathological evidence.\n* Known diagnosis of CD, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis or microscopic colitis.\n* Positive stool culture for active C. difficile.\n* Pregnant women.\n* Allergy to soy or fructose (contained in Prolife 10 FORTE)\n* Patients under antibiotic and\u002For probiotic treatment within 10 days before visit1.","ALL","18 Years","75 Years",{"count":79,"type":80},70,"ESTIMATED","INTERVENTIONAL",[83],"NA","This clinical trial aims to learn if the probiotic Prolife 10 Forte could improve the Gut Microbiota composition of Ulcerative colitis patients during the remission phase. The main questions it seeks to answer are:\n\n* Does Prolife 10 Forte improve the microbiota composition in patients with Ulcerative colitis?\n* Is it possible to highlight the variation in microbial pathways?\n* What clinical parameters vary and are associated with changes in the gut microbiota? Researchers will compare Prolife 10 Forte to a placebo (a look-alike substance containing no drug) to see if the probiotics improve microbiota.\n\nParticipants will:\n\n* Take 1 vial\u002Fday of Prolife 10 Forte \u002FPlacebo for 60 days.\n* Visit the clinic two times for checkups, Questionaire and tests",[86],"Ulcerative Colitis in Remission",[88],"Microbiota, Probiotics","2024-10-14",{"date":91,"type":92},"2024-10-15","ACTUAL",{"date":94,"type":92},"2024-05-15",{"date":96,"type":80},"2026-06-15",{"name":5,"class":6},1]