[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100502342":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":48,"centralContacts":53,"locations":59,"responsibleParty":77,"collaborators":30,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":30,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":30,"overallStatus":61,"whyStopped":30,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",[8,18],{"label":9,"type":10,"description":11,"interventionNames":12},"LFMT-capsules","EXPERIMENTAL","LFMT-capsules. 3 times bulk, and further continuous administration. This arm is also treated pre- and probiotics.",[13,14,15,16,17],"Combination Product: Lyophilized fecal microbiota transplantation capsules","Dietary Supplement: A. soehngenii","Dietary Supplement: Pasteurized A. muciniphila","Dietary Supplement: B. animalis subsp. lactis","Dietary Supplement: Fructo-oligosaccharides",{"label":19,"type":20,"description":21,"interventionNames":22},"Placebo","PLACEBO_COMPARATOR","Placebo-capsules. 3 times bulk, and further continuous administration. This arm is also treated pre- and probiotics.",[23,14,15,16,17],"Combination Product: Placebo capsules",[25,31,34,38,41,44],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"COMBINATION_PRODUCT","Lyophilized fecal microbiota transplantation capsules","Oral administration (capsule)",[9],null,{"type":26,"name":32,"description":28,"armGroupLabels":33,"otherNames":30},"Placebo capsules",[19],{"type":35,"name":36,"description":28,"armGroupLabels":37,"otherNames":30},"DIETARY_SUPPLEMENT","A. soehngenii",[9,19],{"type":35,"name":39,"description":28,"armGroupLabels":40,"otherNames":30},"Pasteurized A. muciniphila",[9,19],{"type":35,"name":42,"description":28,"armGroupLabels":43,"otherNames":30},"B. animalis subsp. lactis",[9,19],{"type":35,"name":45,"description":46,"armGroupLabels":47,"otherNames":30},"Fructo-oligosaccharides","Oral administration (dissolved in water)",[9,19],[49],{"name":50,"affiliation":51,"role":52},"A.G. Holleboom, MD, PhD","Amsterdam UMC","PRINCIPAL_INVESTIGATOR",[54],{"name":55,"role":56,"phone":57,"phoneExt":30,"email":58},"Quinten Augustijn, MD","CONTACT","+31205661267","q.j.augustijn@amsterdamumc.nl",[60],{"facility":51,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"RECRUITING","Amsterdam","North Holland","1105AZ","Netherlands","NL",{"type":68,"coordinates":69},"Point",[70,71],4.88969,52.37403,{"lat":71,"lon":70},[74],{"name":75,"role":56,"phone":76,"phoneExt":30,"email":58},"Q.J.J. Augustijn, MD","+315661267",{"type":52,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Onno Holleboom, MD, PhD","Principal Investigator","100502342","phase-2-synbiotics-and-fecal-microbiota-transplantation-to-treat-non-alcoholic-steatohepatitis-100502342",false,"NCT05821010","Synbiotics and Fecal Microbiota Transplantation to Treat Non-Alcoholic Steatohepatitis","SYNCH","Inclusion Criteria:\n\n* biopsy-proven NASH obtained up to 32 weeks before screening: SAF Steatosis score ≥1, Activity ≥2, Fibrosis \\\u003C4; 50% of participants should at least have NASH fibrosis stage 1, 2 or 3 according to the NASH CRN fibrosis staging system based on tandem reading of two expert liver pathologists\n* fluency in Dutch or English\n* participants should be able to understand the information and give informed consent\n\nExclusion Criteria:\n\n* Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year before screening (significant alcohol consumption is defined as more than 2 international units\u002Fday for females and more than 3 international units\u002Fday for males, on average; 1 international unit contains ±14 grams of alcohol)\n* liver cirrhosis or hepatocellular carcinoma\n* hepatitis B and\u002For C\n* auto-immune hepatitis\n* Wilson's disease\n* primary sclerosing cholangitis\n* primary biliary cholangitis\n* alpha-1-antitripsine deficiency and hemochromatosis\n* history of liver transplant, current placement on a liver transplant list\n* use of pre-, pro- or synbiotics\n* use of systemic antibiotics 3 month prior to randomization\n* use of tamoxifen, methotrexate or amiodarone\n* prior or planned bariatric surgery\n* active GLP-1 receptor agonist treated diabetes mellitus\n* bleeding disorder\n* International normalized ratio (INR) of prothrombin time \\>1.4 or platelet count \\\u003C100 109\u002FL at screening\n* anti-platelet\u002Fcoagulant therapy use which cannot be temporarily discontinued\n* any major cardiovascular event within 6 months prior to screening (e.g. myocardial infarction, cerebrovascular accident)\n* prolonged compromised immunity (e.g. recent cytotoxic chemotherapy, HIV-infection with a CD4 count \\\u003C 240)\n* active or prior history of invasive malignancy (except for curatively treated in situ carcinomas \\[e.g., cervix\\] or non-melanoma skin cancer) unless a complete remission was achieved\n* surgery scheduled for the trial duration period, except for minor surgical procedures, in the opinion of the investigator\n* pregnant or nursing women\n* any condition which, in the investigator's opinion, might jeopardize participants' safety or compliance with the protocol\n* participation in another concomitant clinical trial.","ALL","18 Years","75 Years",{"count":91,"type":92},48,"ESTIMATED","INTERVENTIONAL",[95],"PHASE2","The goal of this clinical trial is to investigate the therapeutic potential of A. soehngenii and pasteurized A. muciniphila combined with B. animalis subsp. lactis and fructo-oligosaccharides with and without conditioned vegan lyophilized fecal microbiota transplantation capsules to reduce NASH in patients with fibrotic NASH. The main questions to answer are:\n\n1. Can NASH be treated by altering the gut microbiota using LFMT capsules?\n2. Can NASH be treated using a syntrophic cocktail of synbiotics and will these strains strengthen the effect of FMT?\n3. What are the underlying mechanism by which the aforementioned treatments attenuate NASH?\n\nParticipants will be treated with FMT-capsules or placebo, and all participants will receive a cocktail of 3 strains of probiotics and one type of prebiotic.",[98,99,100,101,102,103,104,105,106],"Non Alcoholic Steatohepatitis","Non-Alcoholic Fatty Liver Disease","Fecal Microbiota Transplantation","FMT","Prebiotics","Probiotics","Microbiome","Intestinal Microbiome","Gut Microbiome","2024-08-26",{"date":109,"type":110},"2024-08-27","ACTUAL",{"date":112,"type":110},"2023-03-17",{"date":114,"type":92},"2026-08-20",{"name":5,"class":6},1]