[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533633":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":27,"centralContacts":35,"locations":45,"responsibleParty":67,"collaborators":69,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":10,"maxAge":81,"enrollmentInfo":82,"targetDuration":10,"studyType":85,"phases":10,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":48,"whyStopped":10,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Ulcerative colitis flare-up",null,"Patient with ulcerative colitis, whatever the extent, except isolated proctitis (\\\u003C5 cm), diagnosed for more than 3 months, presenting with a flare of UC defined by a Pediatric Ulcerative Colitis Activity Index (PUCAI) score between 35 and 65.",[13],"Other: Feces collection",{"label":15,"type":10,"description":16,"interventionNames":17},"Ulcerative colitis remission","Patient with ulcerative colitis, whatever the extent, except isolated proctitis (\\\u003C5 cm), diagnosed for more than 3 months and in clinical remission defined by a Pediatric Ulcerative Colitis Activity Index (PUCAI) score under 10.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Controls","Paediatric patients (\\\u003C18 years) without chronic liver disease or chronic digestive disease (celiac disease, inflammatory bowel disease, chronic diarrhea) and hospitalized for an endoscopic examination to investigate abdominal pain, gastroesophageal reflux or polyposis.",[13],[23],{"type":6,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"Feces collection","A single stool sample will be taken (a specific kit will be given to the patient for this) during a consultation for follow-up or hospitalization.\n\nStool samples will be used to study the composition of the intestinal microbiota and to measure faecal biomarkers.",[19,9,15],[28,31],{"name":29,"affiliation":5,"role":30},"Bénédicte Pigneur, MD","PRINCIPAL_INVESTIGATOR",{"name":32,"affiliation":33,"role":34},"Frédéric Barbut, PhD","Institut National de la Santé Et de la Recherche Médicale, France","STUDY_DIRECTOR",[36,41],{"name":29,"role":37,"phone":38,"phoneExt":39,"email":40},"CONTACT","1 44 49 25 16","+33","benedicte.pigneur@aphp.fr",{"name":42,"role":37,"phone":43,"phoneExt":39,"email":44},"Hélène Morel","1 71 19 63 46","helene.morel@aphp.fr",[46],{"facility":47,"status":48,"city":49,"state":10,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Hôpital Necker-Enfants Malades","RECRUITING","Paris","75015","France","FR",{"type":54,"coordinates":55},"Point",[56,57],2.3488,48.85341,{"lat":57,"lon":56},[60,62,65],{"name":29,"role":37,"phone":61,"phoneExt":39,"email":40},"1 44 49 25 60",{"name":63,"role":64,"phone":10,"phoneExt":10,"email":10},"Antonin Lamazière","SUB_INVESTIGATOR",{"name":66,"role":64,"phone":10,"phoneExt":10,"email":10},"Nathalie Kapel",{"type":68,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[70],{"name":71,"class":6},"URC-CIC Paris Descartes Necker Cochin","100533633","role-of-bile-acids-and-microbiota-in-clostridioides-difficile-infection-in-ulcerative-colitis-100533633",false,"NCT06228352","Role of Bile Acids and Microbiota in Clostridioides Difficile Infection in Ulcerative Colitis","Is Clostridioides Difficile Infection Associated With Changes in Bile Acid Profiles in Children With Ulcerative Colitis","ABRICO","For everyone :\n\nInclusion Criteria:\n\n* Pediatric patients (\\\u003C18 years) consultant or hospitalized in the Gastroenterology department of Necker-Enfants Malades Hospital.\n* Information and consent of parents and the patient\n\nExclusion Criteria:\n\n* Patient who received antibiotic or antifungal treatment in the 4 weeks prior to inclusion.\n* Patients colonized by C. difficile.\n* Pregnant or breastfeeding young girl.\n* Refusal of the protocol by parents or patient.\n\nFor group 1: Patients with active UC\n\nInclusion criteria:\n\n* Patient with UC, whatever the extent, except isolated proctitis (\\\u003C5 cm), diagnosed for more than 3 months according to the usual clinical, biological and endoscopic criteria.\n* UC in flare defined by a PUCAI score of between 35 and 65.\n\nNon-inclusion criteria:\n\n* Patient with IBD unclassified or Crohn's disease.\n* Patient with isolated proctitis (\\\u003C5 cm).\n* Colectomized patients.\n* Patients with sclerosing cholangitis associated with their UC or liver disease.\n\nGroup 2: Patients in UC remission\n\nInclusion criteria:\n\n* Patient with UC, whatever the extent, except isolated proctitis (\\\u003C5 cm), diagnosed for more than 3 months according to the usual clinical, biological and endoscopic criteria.\n* UC in remission defined by a PUCAI score \\\u003C10.\n\nNon-inclusion criteria:\n\n* Patient with IBD unclassified or Crohn's disease.\n* Patient with isolated proctitis (\\\u003C5 cm).\n* Colectomized patients.\n* Patients with sclerosing cholangitis associated with their UC or liver disease.\n\nGroup 3: Healthy control subjects\n\nInclusion criteria:\n\n\\- Patients hospitalized for an endoscopic assessment to control for abdominal pain, gastroesophageal reflux or polyposis.\n\nNon-inclusion criteria:\n\n* Patient with chronic liver disease.\n* Patient with chronic digestive disease (celiac disease, IBD, chronic chronic).","ALL","17 Years",{"count":83,"type":84},80,"ESTIMATED","OBSERVATIONAL","Ulcerative Colitis (UC) is a chronic Inflammatory Bowel Disease characterized by chronic inflammation of the colon. Composition of gut microbiota of UC patients is abnormal (dysbiosis).\n\nUlcerative Colitis patients have an increased risk of Clostridioides difficile infection (CDI) and CDI complications (colectomy, death, recurrence). The reason for this increased risk in IBD patients is not fully understood. The decrease in the proportion of secondary bile acids, induced by microbiota dysbiosis in patients with UC could favor C. difficile infection.\n\nThe main objective of the study is to describe the composition of bile acids (primary and secondary) in children followed for UC during relapse with or without CDI and to compare it to children with UC in remission and healthy controls. The composition of fecal microbiota will be also describe to correlate dysbiosis and bile acid abnormalities. And finally some fecal biomarkers will be study : short chain fatty acids, metabolic pathway of Tryptophan, and fecal Calprotectin.",[88],"Ulcerative Colitis",[90,91,92,93],"Ulcerative colitis","Clostridioides difficile infection","Intestinal dysbiosis","Bile acid profiles","2026-06-22",{"date":96,"type":97},"2026-06-24","ACTUAL",{"date":99,"type":97},"2026-06-09",{"date":101,"type":84},"2029-06",{"name":5,"class":6},1]