[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650890":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":31,"responsibleParty":50,"collaborators":26,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":26,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":75,"overallStatus":80,"whyStopped":26,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"University of Padova","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dietary Supplement Group (Treatment A)","ACTIVE_COMPARATOR","In this arm patients receive 2 tablets\u002Fday of Colipral (1\u002Fbreakfast, and 1\u002Fdinner, before the meal) for 60 days",[13],"Dietary Supplement: Food Supplement Colipral in film-coated tablets containing Escherichia coli 5C LMG S-33222",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Group (Treatment B)","PLACEBO_COMPARATOR","In this arm patients receive 2 tablets\u002Fday of placebo (1\u002Fbreakfast, and 1\u002Fdinner, before the meal) for 60 days",[19],"Other: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Food Supplement Colipral in film-coated tablets containing Escherichia coli 5C LMG S-33222","2 tablets\u002Fday of Colipral (1\u002Fbreakfast, and 1\u002Fdinner, before the meal) for 60 days",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","2 tablets\u002Fday of Placebo (1\u002Fbreakfast, and 1\u002Fdinner, before the meal) for 60 days",[15],[32],{"facility":33,"status":26,"city":34,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Azienda Ospedale - Univeristà Padova","Padova","35128","Italy","IT",{"type":39,"coordinates":40},"Point",[41,42],11.14261,44.38225,{"lat":42,"lon":41},[45],{"name":46,"role":47,"phone":48,"phoneExt":26,"email":49},"Fabiana Zingone","CONTACT","+39 0498215656","fabiana.zingone@unipd.it",{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","ZINGONE FABIANA","Professor","100650890","evaluation-of-the-effects-of-colipral-on-microbiota-gut-composition-in-patients-presenting-with-ulcerative-colitis-during-remission-phase-and-functional-disorders-100650890",false,"NCT07751081","Evaluation of the Effects of Colipral on Microbiota Gut Composition in Patients Presenting With Ulcerative Colitis During Remission Phase and Functional Disorders","Evaluation of the Effects of Colipral® (E.Coli 5C LMG S-33222) on Microbiota Gut Composition in Patients Presenting With Ulcerative Colitis During Remission Phase and Functional Disorders","COLIPRAL","Inclusion criteria:\n\n* Diagnosis of UC confirmed by clinical, endoscopic and histopathological evidence.\n* Disease in remission phase confirmed by clinical, endoscopic and histopathological evidence for at least 6 months\n* Diagnosis of disorders of gut-brain interaction (DGBI): IBS-D, IBS-M, bloating, and abdominal pain\n* Male\u002Ffemale\n* Age in the range 18-70 years\n* Subjects capable of conforming to the study protocol\n* Subjects who have given their free and informed consent\n\nExclusion criteria:\n\n* History of gastrointestinal disorders or gastrointestinal surgery interfering with gastrointestinal function\n* Subjects with untreated food intolerance, i.e. remaining symptomatic despite the withdrawal of the suspected food\n* Currently following a restrictive diet (for example low FODMAPs diet or vegan diet)\n* Females of childbearing potential, in the absence of effective contraceptive methods\n* Subjects who become unable to conform to protocol\n* Recent history or suspicion of alcohol abuse or drug addiction\n* Indication for the initiation of a new drug therapy during the study\n* History of current or recent antibiotic or probiotics use within the last 30 days\n* Subjects who are treated with antibiotics","ALL","18 Years","70 Years",{"count":66,"type":67},50,"ESTIMATED","INTERVENTIONAL",[70],"NA","The study is a double-blind, placebo-controlled, crossover, randomised trial, in which enrolled subjects will be included for 18 months. This study aims to evaluate the effect of the Colipral as a Food Supplement prescribed according to the standard of care of patients suffering UC during remission phase and DGBI.\n\nThe primary objective of the study is to evaluate the variation in gut microbiota, specifically focusing on bacterial diversity and abundance, in patients with UC during the remission phase and DGBI.\n\nThe secondary objective of the study is to evaluate the clinical parameters variations (based on fecal calprotectin and IBDQ's score before and after the treatment), the severity of gastrointestinal symptoms, the quality of life, and the maintenance of the remission phase in patients with UC in remission and DGBI.",[73,74],"Inflammatory Bowel Disease, Ulcerative Colitis Type","Functional Disorder of Gastrointestinal Tract",[76,77,78,79],"inflammatory bowel disease","ulcerative colitis","functional disorders","gut microbiota","NOT_YET_RECRUITING","2026-08-03",{"date":83,"type":84},"2026-08-07","ACTUAL",{"date":86,"type":67},"2026-09-01",{"date":88,"type":67},"2028-03",{"name":5,"class":6},1]