[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627882":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":41,"centralContacts":76,"locations":81,"responsibleParty":98,"collaborators":40,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":40,"eligibilityCriteria":107,"healthyVolunteers":108,"sex":109,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":40,"studyType":115,"phases":116,"briefSummary":119,"conditions":120,"keywords":123,"overallStatus":124,"whyStopped":40,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"Air Force Military Medical University, China","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Fecal Microbiota Transplantation Group","EXPERIMENTAL","All the subjects in this arm continued to receive standard medical treatment for hepatic encephalopathy: rifaximin 0.2g per tablet, 2 tablets per dose, 3 times a day, with a total daily dose of 1200mg; lactulose oral solution 25ml per dose, 2 times a day, with the dosage adjusted as needed according to clinical requirements. On the basis of the standard treatment, the subjects received intranasal jejunal tube infusion of fecal suspension (100mL per dose, 2 times a day, for 3 consecutive days), followed by oral enteric-coated freeze-dried fecal capsules (7 capsules per day, for 1 week). The fecal preparation was prepared under sterile conditions. The donor feces used were all subjected to strict screening for infectious diseases and pathogenicity and were rich in Clostridium mucosum, Rumenoccus, and Bifidobacterium.",[13,14],"Biological: Fecal Microbiota Transplantation","Drug: Rifaximin、Lactulose",{"label":16,"type":17,"description":18,"interventionNames":19},"Placebo Control Group","PLACEBO_COMPARATOR","All subjects in this arm will receive the exact same standard medical therapy as the FMT group: rifaximin 0.2g tablets, 2 tablets each time, 3 times daily (total 1200mg per day); lactulose oral solution 25ml each time, twice daily, with dose adjusted according to clinical needs. On top of standard therapy, subjects will receive isovolumetric placebo solution via nasojejunal tube infusion (same frequency and duration as the FMT group), followed by matched oral placebo capsules (same dosage, frequency and duration as the FMT group). Placebo preparations are identical to FMT preparations in appearance, dosage form and administration route.",[20,14],"Other: FMT Matched Placebo",[22,29,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"BIOLOGICAL","Fecal Microbiota Transplantation","Fecal microbiota transplantation is used to reconstruct gut microbiota structure, regulate intestinal microecological homeostasis, improve intestinal barrier function, reduce systemic endotoxin load and inflammatory level, for the prevention and treatment of refractory hepatic encephalopathy after TIPS. The preparation is made from stool of qualified screened donors, processed under sterile conditions.",[9],[28],"FMT",{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"FMT Matched Placebo","Placebo preparation is identical to fecal microbiota transplantation preparation in appearance, dosage form, administration route and frequency, with no active biological or therapeutic components, used for the control arm of this randomized controlled trial.",[16],[34],"Placebo",{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DRUG","Rifaximin、Lactulose","Rifaximin is a non-absorbable oral rifamycin antibiotic, used as standard medical therapy for hepatic encephalopathy, to reduce intestinal urease-producing bacteria and intestinal ammonia production.Lactulose is a synthetic disaccharide laxative, used as first-line standard medical therapy for hepatic encephalopathy, to acidify the intestinal lumen, reduce ammonia production and promote ammonia excretion.",[9,16],null,[42,46,48,52,54,56,58,60,62,64,66,68,70,72,74],{"name":43,"affiliation":44,"role":45},"Guohong HAN, Professor","Xi'an International Medical Center Hospital","STUDY_CHAIR",{"name":43,"affiliation":44,"role":47},"PRINCIPAL_INVESTIGATOR",{"name":49,"affiliation":50,"role":51},"Mingtao ZHAO","Xi'an Jiaotong University","STUDY_DIRECTOR",{"name":53,"affiliation":44,"role":51},"Menghao LI",{"name":55,"affiliation":44,"role":51},"Heng ZENG",{"name":57,"affiliation":44,"role":51},"Xing WANG",{"name":59,"affiliation":44,"role":51},"Gui ZHANG",{"name":61,"affiliation":44,"role":51},"Zhanxin YIN",{"name":63,"affiliation":44,"role":51},"Ruijun LI",{"name":65,"affiliation":44,"role":51},"Wei BAI",{"name":67,"affiliation":44,"role":51},"Dongdong XIA",{"name":69,"affiliation":44,"role":51},"Na ZHANG",{"name":71,"affiliation":44,"role":51},"Zhengyu WANG",{"name":73,"affiliation":44,"role":51},"Bohan LUO",{"name":75,"affiliation":44,"role":51},"Feifei WU",[77],{"name":43,"role":78,"phone":79,"phoneExt":40,"email":80},"CONTACT","13991969930","13991969930@126.com",[82],{"facility":44,"status":40,"city":83,"state":84,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"Xi’an","Shanxi","710100","China","CN",{"type":89,"coordinates":90},"Point",[91,92],113.52486,35.99785,{"lat":92,"lon":91},[95],{"name":96,"role":78,"phone":97,"phoneExt":40,"email":80},"Guohong HAN, MD, PhD","86-29-84771537",{"type":47,"investigatorFullName":99,"investigatorTitle":100,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"Guohong Han","Professor","100627882","phase-1-evaluation-of-the-outcome-of-fecal-microbiota-transplantation-100627882",false,"NCT07454408","Evaluation of the Outcome of Fecal Microbiota Transplantation","A Clinical Randomized Controlled Study on the Prevention and Treatment of Drug-refractory Hepatic Encephalopathy After TIPS With Fecal Microbiota Transplantation","Inclusion Criteria:\n\n* Aged between 18 and 75 years old\n* Patients who have experienced esophageal-gastric variceal bleeding or recurrent refractory ascites and meet the inclusion criteria, and for whom conservative treatment has failed, are planned to undergo elective TIPS surgery\n* Patients with recurrent hepatic encephalopathy (HE) after transjugular intrahepatic portosystemic shunt (TIPS), despite treatment with lactulose and rifaximin (at least 2 episodes of West Haven grade ≥2 HE within 6 months under lactulose and rifaximin intervention)\n* Provided written informed consent from the patient\n\nExclusion Criteria:\n\n* Malignant tumors of the liver, gastrointestinal tract or other systems\n* Uncontrolled severe active infection (\\>grade 2) or sepsis\n* Spontaneous bacterial peritonitis\n* Complicated with severe cardiac, renal or pulmonary insufficiency\n* Other neuropsychiatric diseases, including dementia\n* Budd-Chiari syndrome\n* Alcohol dependence or use of psychotropic drugs (benzodiazepines, opioids, etc.)\n* History of gastrointestinal surgery (e.g., colectomy) within 3 months before enrollment\n* Pregnant or lactating subjects\n* Poor compliance judged by the investigator\n* Model for End-Stage Liver Disease (MELD) score \\>17\n* Tumor, immunodeficiency, or receiving immunosuppressive therapy within 3 months before enrollment\n* Patients who have used other prebiotics, probiotics or fecal microbiota transplantation (FMT) before enrollment",true,"ALL","18 Years","75 Years",{"count":113,"type":114},40,"ESTIMATED","INTERVENTIONAL",[117,118],"PHASE1","PHASE2","This study is a randomized, placebo-controlled, exploratory phase II clinical trial led by Professor Han Gyeong-ho from the Digestive Disease Hospital of Xi'an International Medical Center. The study enrolled 40 patients who had experienced recurrence of hepatic encephalopathy despite treatment with rifaximin and lactulose. These patients were randomly divided 1:1 into the experimental group and the control group. After obtaining informed consent from the patients, fecal microbiota transplantation or placebo control was performed. The fecal microbiota was sourced from the feces of healthy individuals who had a rich composition of the Muribaculaceae, Ruminococcaceae, and Bifidobacteriaceae families and did not contain pathogenic bacteria. The safety and efficacy of the treatment were followed up, and blood and fecal samples were collected for sequencing analysis. The aim was to provide new solutions for patients with hepatic encephalopathy who did not respond to the treatment with rifaximin and lactulose after TIPS surgery; and to explore the impact of microbiota changes and translocation on the recurrence of hepatic encephalopathy after TIPS surgery.",[121,24,122],"Hepatic Encephalopathy","TIPS",[121,24,122,28],"NOT_YET_RECRUITING","2026-03-05",{"date":127,"type":128},"2026-03-06","ACTUAL",{"date":130,"type":114},"2026-03-07",{"date":132,"type":114},"2028-06-30",{"name":5,"class":6},1]