[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604768":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":28,"locations":34,"responsibleParty":58,"collaborators":25,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":25,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":25,"overallStatus":36,"whyStopped":25,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Changhai Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","Physiological saline placebo will be injected through a nasojejunal nutrition tube once a day for five days.",[13],"Procedure: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"FMT","EXPERIMENTAL","FMT bacterial solution will be injected through a nasojejunal nutrition tube once a day for five days.\n\nAfter intestinal preparation (via nasal feeding of inulin or oligofructose 24 hours before FMT), the subjects underwent 5-6 consecutive FMT treatments (injecting 100ml of standard bacterial solution 1\u002Fd into the nasojejunal nutrition tube, with a minimum of 2.5 \\* 1012 CFU of viable cells per 50mL of bacterial solution).\n\nFMT intervention can be performed when the subject's intestinal function is restored and SIRS indicators are significantly relieved compared to before.\n\nDuring the research period, long-term use of probiotics, antibiotics, and other foods and drugs that interfere with and damage gut microbiota is prohibited. Subjects need to be informed in advance before taking any medication.\n\nAll subjects need to complete relevant examinations before enrollment. Conduct a comprehensive safety and efficacy evaluation during treatment, after treatment, and one week after treatment.",[19],"Procedure: FMT",[21,26],{"type":22,"name":15,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","FMT bacterial solution will be injected through a nasojejunal nutrition tube once a day for five days.",[15],null,{"type":22,"name":9,"description":11,"armGroupLabels":27,"otherNames":25},[9],[29],{"name":30,"role":31,"phone":32,"phoneExt":25,"email":33},"Kong Xiang yu, associate professor","CONTACT","13564644397","xiangyukong185@hotmail.com",[35,51],{"facility":5,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","Shanghai","Shanghai Municipality","200433","China","CN",{"type":43,"coordinates":44},"Point",[45,46],121.45806,31.22222,{"lat":46,"lon":45},[49],{"name":50,"role":31,"phone":32,"phoneExt":25,"email":33},"Kong Xiang yu, Associate Professor",{"facility":5,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":52,"geoPoint":54,"contacts":55},{"type":43,"coordinates":53},[45,46],{"lat":46,"lon":45},[56],{"name":57,"role":31,"phone":32,"phoneExt":25,"email":33},"Xiangyu Kong",{"type":59,"investigatorFullName":57,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Principle Investigator","100604768","fecal-microbiota-transplantation-fmt-in-patients-with-moderate-to-severe-acute-pancreatitis-100604768",false,"NCT07153809","Fecal Microbiota Transplantation (FMT) in Patients With Moderate to Severe Acute Pancreatitis","Randomized, Double-blind Clinical Trial on the Efficacy and Safety of Gut Microbiota Transplantation (FMT) in the Treatment of Moderate to Severe Acute Pancreatitis","Inclusion Criteria:\n\nAge: 18-70 years old Diagnosis: Meets the diagnostic criteria for severe acute pancreatitis (SAP)\n\n* Organ function: There may be organ failure and systemic complications that can be recovered within 48 hours\n* Stage of the disease: Approximately 2 weeks after onset (non acute phase), accompanied by accumulation of pancreatic fluid volume, and significant improvement in CTSI score compared to before (grade II)\n* Nutritional support: Enteral nutrition tube has been left in place Feasibility of transplantation: No absolute contraindications for gut microbiota transplantation\n* Informed Consent: Voluntarily sign a written informed consent form\n* Gastrointestinal status:\n\nAbdominal pressure (bladder pressure measurement)\\\u003C12mmHg ◦ Existence of spontaneous defecation\u002Fexhaust Significant improvement in abdominal distension compared to before\n\nExclusion Criteria:\n\nSerious complications: combined gastrointestinal bleeding or intestinal fistula\n\n* Special population: Pregnant or lactating women\n* Informed refusal: Failure to sign informed consent form\n* Basic organ dysfunction: Prior to admission, there were chronic organ dysfunction in the heart, lungs, liver, kidneys, or blood system Malignant tumor: Suffering from incurable malignant tumors\n* Immune abnormalities:\n\nAutoimmune diseases\n\n◦ Immunosuppression status (solid organ\u002Fbone marrow transplantation history, AIDS, long-term use of immunosuppressants\u002Fhormones)\n\n* Enteral nutrition intolerance: unable to meet 50% of calorie requirements due to severe diarrhea, fibrotic intestinal stenosis, severe gastrointestinal edema, high flow intestinal fistula, etc\n* Systemic infection: meets the diagnostic criteria for systemic inflammatory response syndrome (SIRS)\n* Antibiotic dependence: broad-spectrum antibiotic intervention is required for combined extraintestinal organ infections\n* Immunodeficiency: Congenital or acquired immunodeficiency\n* Mental illness: severe mental disorders","ALL","18 Years","70 Years",{"count":72,"type":73},80,"ESTIMATED","INTERVENTIONAL",[76],"NA","This study is a randomized, double-blind and placebo-controlled study. The purpose of this study is to evaluate the efficacy and safety of FMT in patients with moderate to severe acute pancreatitis.",[79,80],"Acute Pancreatitis","Severe Acute Pancreatitis","2025-08-31",{"date":83,"type":84},"2025-09-04","ACTUAL",{"date":86,"type":84},"2024-10-12",{"date":88,"type":73},"2026-12-31",{"name":5,"class":6},2]