[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633592":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":45,"responsibleParty":95,"collaborators":30,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":99,"sex":105,"minAge":106,"maxAge":30,"enrollmentInfo":107,"targetDuration":30,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":117,"overallStatus":123,"whyStopped":30,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"VA Office of Research and Development","FED",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"MTT","EXPERIMENTAL","Microbiota transplant therapy (MTT) capsules",[13],"Biological: Microbiota transplant therapy (MTT) capsules",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo capsule",[19],"Other: Placebo capsule",[21,27],{"type":22,"name":11,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","MTP-101-C is manufactured using cGMP protocols in the Molecular and Cellular Therapeutics (MCT) facility at the University of Minnesota.",[9],[26],"MTP-101-C",{"type":28,"name":17,"description":17,"armGroupLabels":29,"otherNames":30},"OTHER",[15],null,[32],{"name":33,"affiliation":34,"role":35},"Jasmohan S. Bajaj, MD MS","Richmond VA Medical Center, Richmond, VA","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":30,"email":41},"Jasmohan S Bajaj, MD MS","CONTACT","(804) 675-5802","Jasmohan.Bajaj@va.gov",{"name":43,"role":39,"phone":40,"phoneExt":30,"email":44},"Brian C Davis, MD","brian.davis5@va.gov",[46,65,80],{"facility":47,"status":30,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"CERC (VISN1, West Haven, CT)","West Haven","Connecticut","06516-2770","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-72.94705,41.27065,{"lat":57,"lon":56},[60],{"name":61,"role":39,"phone":62,"phoneExt":63,"email":64},"Lynn Buchwalder","203-932-5711","5338","Lynn.Buchwalder@va.gov",{"facility":66,"status":30,"city":67,"state":68,"zip":69,"country":51,"countryCode":52,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX","Dallas","Texas","75216-7167",{"type":54,"coordinates":71},[72,73],-96.80667,32.78306,{"lat":73,"lon":72},[76],{"name":77,"role":39,"phone":78,"phoneExt":30,"email":79},"Elizabeth Hernandez","469-231-9343","elizabeth.hernandez4@va.gov",{"facility":34,"status":30,"city":81,"state":82,"zip":83,"country":51,"countryCode":52,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Richmond","Virginia","23249-0001",{"type":54,"coordinates":85},[86,87],-77.46026,37.55376,{"lat":87,"lon":86},[90,94],{"name":91,"role":39,"phone":92,"phoneExt":30,"email":93},"Haley Obolewicz","804-675-5705","haley.obolewicz@va.gov",{"name":33,"role":35,"phone":30,"phoneExt":30,"email":30},{"type":96,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100633592","phase-2-microbiota-transplant-therapy-in-hepatic-encephalopathy-masterpiece-100633592",false,"NCT07528690","Microbiota trAnSplant ThERaPy In hEpatiC Encephalopathy (MASTERPIECE)","Microbiota Transplant Therapy to Prevent HE Recurrence in a Phase 2B Multi-Center Trial of Veterans With Cirrhosis","MASTERPIECE","Inclusion Criteria:\n\n* 21 years of age\n\n  * Cirrhosis diagnosed by any of the following in a patient with chronic liver disease\n\n    * Liver Biopsy\n    * Radiologic evidence of varices, cirrhosis or portal hypertension\n    * Laboratory evidence of platelet count \\\u003C110,000 or AST\u002FALT ratio\\>1\n    * Endoscopic evidence of varices or portal hypertensive gastropathy\n  * Prior overt HE (patient can be on lactulose and\u002For rifaximin 4 weeks stable dosing)\n  * Able to give written, informed consent \\[mini-mental status exam (MMSE)\\]\\>25 at the time of consenting)\n  * For lactulose only group: Prior HE not on rifaximin\n\nExclusion Criteria:\n\n* Disease-related:\n\n  * MELD3.0 score\\>22\n  * WBC count\\\u003C1000\n  * non-elective hospitalization or overt HE episode within 1 month\n  * on dialysis\n  * known untreated, luminal GI cancer\n  * chronic intrinsic GI diseases (ulcerative colitis, Crohn's disease, microscopic colitis, eosinophilic gastroenteritis or celiac disease)\n* Safety-related:\n\n  * Current dysphagia\n  * History of aspiration, intestinal obstruction or non-medication induced gastroparesis\n  * Ongoing absorbable antibiotic use\n  * History of anaphylactic food allergy\n  * Allergy to ingredients in the capsules (glycerol, sodium chloride, hypromellose, gellan gum, titanium dioxide, theobroma oil)\n* Adverse event attributable to prior FMT (7) ASA Class V\n* Pregnant or nursing patients\n* Acute illness or fever on the day of planned FMT\n* History of spontaneous bacterial peritonitis","ALL","21 Years",{"count":108,"type":109},162,"ESTIMATED","INTERVENTIONAL",[112],"PHASE2","The goal of this clinical trial is to find out whether changing the microbes in the bowels of Veterans with cirrhosis and hepatic encephalopathy (a condition that affects the brain as a result of liver problems) using capsules made from microbes from healthy people can prevent future episodes of hepatic encephalopathy.",[115,116],"Hepatic Encephalopathy","Cirrhosis",[118,119,120,121,122],"cirrhosis","hepatic encephalopathy","rifaximin","lactulose","microbiota transplant therapy","NOT_YET_RECRUITING","2026-04-09",{"date":126,"type":127},"2026-04-14","ACTUAL",{"date":129,"type":109},"2026-10-30",{"date":131,"type":109},"2031-03-03",{"name":5,"class":6},3]