[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642387":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":23,"centralContacts":36,"locations":42,"responsibleParty":57,"collaborators":59,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":23,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":93,"whyStopped":23,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Tampere University Hospital","OTHER",[8,14,19,24,27],{"label":9,"type":10,"description":11,"interventionNames":12},"Children with ulcerative colitis and confirmed PSC receiving OVT and conventional treatment","EXPERIMENTAL","PSC is confirmed with MRCP and\u002For biopsy, will receive oral vancomycin (OVT) for 3-6-(12) months depending on the clinical response",[13],"Drug: Oral Vancomycin",{"label":15,"type":16,"description":17,"interventionNames":18},"Children with atypical UC without confirmed PSC receiving OVt and conventional treatment","ACTIVE_COMPARATOR","PSC is not seen in MRCP, will receive oral vancomycin for 3-6-(12) months depending on the clinical response.",[13],{"label":20,"type":21,"description":22,"interventionNames":23},"Children with atypical UC without confirmed PSC receiving conventional treatment only","NO_INTERVENTION","PSC is not seen in MRCP, will not receive oral vancomycin",null,{"label":25,"type":21,"description":26,"interventionNames":23},"Children with typical UC without confirmed PSC receiving conventional treatment only","Typical UC in colonoscopy, will not receive oral vancomycin",{"label":28,"type":21,"description":29,"interventionNames":23},"Children without IBD","Control group for healthy gut microbiota and non-inflammatory gut metabolism",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":23},"DRUG","Oral Vancomycin","Oral vancomycin will be given 50 mg\u002F kg in three divided doses up to 500 mg x 3\u002F day for at least 3 months. In responding children, the treatment will be continued for 6(-12) months depending on the timing if possible follow-up colonoscopy.",[15,9],[37],{"name":38,"role":39,"phone":40,"phoneExt":23,"email":41},"Laura Räisänen, PhD","CONTACT","+358444735309","laura.raisanen@pirha.fi",[43],{"facility":5,"status":23,"city":44,"state":23,"zip":23,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Tampere","Finland","FI",{"type":48,"coordinates":49},"Point",[50,51],23.78712,61.49911,{"lat":51,"lon":50},[54],{"name":55,"role":39,"phone":23,"phoneExt":23,"email":56},"Saara Ojala","saara.ojala@pirha.fi",{"type":58,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[60,63],{"name":61,"class":62},"Fimlab laboratories","UNKNOWN",{"name":64,"class":6},"University of Helsinki","100642387","phase-2-vancomycin-efficacy-in-response-to-dysbiosis-in-atypical-colitis-100642387",false,"NCT07646223","Vancomycin Efficacy in Response to Dysbiosis in Atypical Colitis","The Efficacy of Oral Vancomycin Therapy in Managing Different Phenotypes of Paediatric Inflammatory Bowel Diseases by Correlating Treatment Response to Commensal Microbiota Composition and Function","VERDA","Inclusion criteria.\n\n* children aged 6-15 years\n* able to swallow capsules\n* are scheduled for diagnostic endoscopy at Tampere University\n* has not received oral vancomycin before\n* do not have active infection (such as clostridium or other bacteria)\n* has not received new interventions (medications or new conventional therapies) for treating IBD was given within the past 4 weeks before starting OVT.\n\nExclusion Criteria:\n\n* The presence of PSC without UC, Crohn's disease type of inflammatory bowel diseases.\n* Under the age of 6 years old.\n* Is unable to swallow capsules.\n* Had a previous allergic reaction to vancomycin (such as vancomycin allergy) and\u002For other related antibiotics similar to vancomycin.\n* Presence of malignant disease or potential need for liver transplantation within the following 12 months.\n* Pregnancy\n* Known renal insufficiency or chronic renal disease","ALL","6 Years","15 Years",{"count":77,"type":78},140,"ESTIMATED","INTERVENTIONAL",[81],"PHASE2","The goal of this clinical trial is to learn how oral vancomycin therapy may contribute in treating paediatric inflammatory bowel disease, particularly atypical ulcerative colitis and PSC-associated colitis. It will also give more information on how this treatment affects gut microbiota and metabolism.\n\nThe main questions it aims to answer are:\n\n1. Does oral vancomycin improve disease activity and lead to remission (based on symptoms, biomarkers, and endoscopy findings)?\n2. How does oral vancomycin change gut metabolism?\n3. Does different types of colitis respond differently to oral vancomycin?\n\nResearchers will compare children receiving oral vancomycin plus standard therapy to those receiving standard therapy alone. The gut metabolisim before and after oral vancmycin will also be compared, as well as to healthy controls and children with typical ulcerative colitis.\n\nParticipants will:\n\n1. Take oral vancomycin (if assigned) together with conventional treatment for at least 3 months and up to 12 months depending on response\n2. Visit the clinic approximately every 3 months for checkups, tests, and monitoring\n3. Provide blood, stool, and saliva samples to study disease activity and microbiota activity\n4. Undergo clinical assessments such as symptom scoring, imaging, and possibly endoscopy\n5. Complete questionnaires about quality of life\n6. Be monitored for side effects and treatment response throughout the study period",[84,85,86],"Ulcerative Colitis (UC)","Primary Sclerosing Cholangitis (PSC)","Pediatric Inflammatory Bowel Diseases",[88,89,90,91,92],"PSC-UC","atypical UC","oral vancomycin","colitis","PIBD","NOT_YET_RECRUITING","2026-06-09",{"date":96,"type":97},"2026-06-12","ACTUAL",{"date":99,"type":78},"2026-08-01",{"date":101,"type":78},"2035-12-31",{"name":5,"class":6},1]