[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT02137668":3,"trial-entities:NCT02137668":80,"trial-summary:NCT02137668":84},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":37,"secondary_outcomes":42,"sex":43,"minimum_age":44,"maximum_age":45,"healthy_volunteers":46,"eligibility_criteria":47,"std_ages":55,"locations":58,"central_contacts":75,"overall_officials":76,"references":78,"see_also_links":79},"NCT02137668","Davies 1","Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin","The Human Gastrointestinal Tract Microbiota in the Setting of Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin","RECRUITING","2028-07","2016-11","2016-11-15","2010-07","Sacramento Pediatric Gastroenterology","OTHER",false,"The purpose of this study is twofold. First, is to determine whether vancomycin is effective in the early treatment of Biliary Atresia (BA) and Primary Sclerosing Cholangitis (PSC), and if so, by what mechanism. Secondly, to characterize human intestinal microbial communities and their interactions with the host.","Investigators hope to learn to characterize human intestinal microbial communities (microbiome: the collection or collectivity of microorganisms) using molecular methods, examine the mechanisms of interaction between host and microbiome using genomic approaches, and determine how the microbiome both preserves local health and promotes pathology. Investigation will focus on primary sclerosing cholangitis, biliary atresia, as well as states of health. The composition of the associated microbiome will be assessed based on ribosomal DNA and RNA sequences, and attention will be given to richness (diversity), evenness (relative abundance), and variation with respect to time, person, and anatomic niche. Host response at the adjacent mucosal surface will be assessed based on genome-wide gene expression patterns. In addition, changes in the metabolites of the blood will be analyzed.\n\nTo see if the antibiotic vancomycin, when used for the early treatment of Biliary Atresia (BA) and Primary Sclerosing Cholangitis (PSC) is effective treatment for these diseases. Investigators hope to learn what effect Vancomycin has on the bacteria that are present in stool, body fluid or intestinal tissue on someone who has BA and PSC and if so by what mechanism.",[19,20],"Primary Sclerosing Cholangitis","Biliary Atresia",[],"INTERVENTIONAL","TREATMENT",[25],"PHASE1",{"count":27,"type":28},200,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Oral Vancomycin","Oral Vancomycin is given to PSC or BA participants",[32],[36],"ANI",[38],{"measure":39,"description":40,"timeFrame":41},"Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis and Biliary Atresia","Blood tests, imaging studies and\u002For liver biopsy changes before and while on oral vancomycin will determine the benefit of the treatment.","3 months",[],"ALL","2 Weeks","40 Years",true,{"inclusion":48,"exclusion":51,"raw_text":54},[49,50],"Persons who have primary sclerosing cholangitis, biliary atresia, a chronic intestinal disorder or who are undergoing upper or lower endoscopy.","Persons who have primary sclerosing cholangitis or biliary atresia who are good candidates for vancomycin therapy.",[52,53],"Patients that have taken antibiotics and\u002For immunomodulators within the last 3 months will be excluded as this will alter the original bacterial flora.","Females who are pregnant may not participate.","Inclusion Criteria:\n\n* Persons who have primary sclerosing cholangitis, biliary atresia, a chronic intestinal disorder or who are undergoing upper or lower endoscopy.\n* Persons who have primary sclerosing cholangitis or biliary atresia who are good candidates for vancomycin therapy.\n\nExclusion Criteria:\n\n* Patients that have taken antibiotics and\u002For immunomodulators within the last 3 months will be excluded as this will alter the original bacterial flora.\n* Females who are pregnant may not participate.",[56,57],"CHILD","ADULT",[59],{"facility":13,"status":8,"city":60,"state":61,"zip":62,"country":63,"contacts":64,"geoPoint":72},"Sacramento","California","95841","United States",[65,69],{"name":66,"role":67,"phone":68},"Yinka Davies, MD","CONTACT","916-332-1244",{"name":70,"role":71},"Yinka Davies, M.D.","PRINCIPAL_INVESTIGATOR",{"lat":73,"lon":74},38.58157,-121.4944,[],[77],{"name":70,"affiliation":13,"role":71},[],[],{"nct_id":4,"conditions":81,"biomarkers":83},[20,82,19],"Intestinal Disorder",[],{"nct_id":4,"found":46,"summary":85,"prompt_version":95},{"design":86,"status":87,"heading":88,"summary":89,"follow_up":90,"word_count":91,"commitments":92,"compensation":93,"drugs_mentioned":94},"This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 200 participants.","completed","Vancomycin for Primary Sclerosing Cholangitis and Biliary Atresia","This study is testing whether oral vancomycin, an antibiotic, can effectively treat Primary Sclerosing Cholangitis (PSC) and Biliary Atresia (BA) in their early stages. Researchers also want to understand how vancomycin affects the bacteria in your gut (intestinal microbial communities) and how these bacteria interact with your body. You may be able to join if you have PSC, BA, a chronic intestinal disorder, or are having an endoscopy, and are between 2 weeks and 40 years old. The main goal is to see if vancomycin helps improve these conditions after 3 months. The study is currently unclear on its recruitment status and plans to enroll 200 participants.","The primary benefit of oral vancomycin therapy will be measured at 3 months.",107,"Not specified in the trial record.","Not stated in the trial record.",[32],"v2"]