[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561117":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":45,"responsibleParty":61,"collaborators":64,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":26,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":26,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Universitas Diponegoro","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"RILLUS","ACTIVE_COMPARATOR","Treatment group receive RILLUS, a synbiotic that each tablet contains Viable cells 1.0 x 109 CFU containing three types of prebiotic species (Lactobacillus plantarum 8.55mg, Streptococcus thermophilus 8.55mg, and Bifidobacterium bifidum 2.55 mg) and Fructooligosaccharide (FOS) 480 mg as prebiotic.",[13],"Dietary Supplement: Treatment",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Control group receive what appeared to be RILLUS, but only placebo containing Fructooligosaccharide, Xylitol DC, Isomalt, Microcrystalline cellulose, Corn starch, Milk flavor powder, Hydroxypropyl methylcellulose, Vanilla flavor powder, Magnesium stearate",[19],"Dietary Supplement: Control",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Treatment","RILLUS is a synbiotic produced by Kalbe Farma",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Control","Placebo produced by Kalbe Farma",[15],[32],{"name":33,"affiliation":34,"role":35},"Hery D Purnomo, Dr","Dr. Kariadi Medical Hospital","PRINCIPAL_INVESTIGATOR",[37,41],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","+628122803136","herydjagat@yahoo.co.id",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"Adiyan Pramono, PhD","+6281282037051","adriyanpramono@fk.undip.ac.id",[46],{"facility":47,"status":48,"city":49,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RSUP Dr. Kariadi","RECRUITING","Semarang","50244","Indonesia","ID",{"type":54,"coordinates":55},"Point",[56,57],110.42083,-6.99306,{"lat":57,"lon":56},[60],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},{"type":35,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Adriyan Pramono","Lecturer",[65,67],{"name":66,"class":6},"Dr. Kariadi General Hospital Medical Center",{"name":68,"class":69},"PT Kalbe Farma Tbk","INDUSTRY","100561117","synbiotics-impact-on-insulin-and-tnf--in-mafld-a-gut-microbiota-profile-analysis-100561117",false,"NCT06585982","Synbiotics Impact on Insulin and TNF-α in MAFLD: a Gut Microbiota Profile Analysis","Gut Microbiota Profile Analysis and Randomized Controlled Trials (RCT) Study of the Effect of Synbiotics on Insulin and TNF-α in Metabolic Dysfunction -Associated Fatty Liver Disease (MAFLD)","Inclusion Criteria:\n\n1. Adult patients aged 25-55 years\n2. Patients are willing to become research respondents after filling out informed consent\n3. Patients can and are willing to consume supplements orally within a predetermined time\n4. Patients are willing to record compliance with taking supplements in a diary that has been provided\n5. Patients diagnosed with MAFLD by FibroScan interpreted by a specialist in gastroenterology-hepatology with a CAP score ≥263 dB\u002Fm\n\nExclusion Criteria:\n\n1. Patients with hepatitis (hepatitis B, hepatitis C, and autoimmune hepatitis) and alcoholic liver disease, cirrhosis of the liver\n2. Patients who are pregnant, or breastfeeding or in a programme to become pregnant during participation in this study.\n3. Patients with a history of alcohol consumption \\>40 g\u002Fday.\n4. Patients with a history of decompensated disease including ascites, encephalopathy, variceal haemorrhage\n5. Patients with Hepatocellular Carcinoma (HCC)\n6. Patients with a history of bowel resection or bariatric surgery Patients with chronic inflammatory bowel disease (IBD)\n7. Patients with a history of antibiotic use or probiotic\u002Fprebiotic\u002Fsynbiotic consumption in the past 1 month\n8. Use of Vitamin E and omega-3 fatty acids\n9. Patients who were not hospitalised in the last month and therefore did not have any food restrictions related to their illness.","ALL","25 Years","55 Years",{"count":81,"type":82},50,"ESTIMATED","INTERVENTIONAL",[85],"NA","Primary Objective: To analyze the effect of synbiotic supplementation on metabolic profile, insulin and TNF-α and gut microbiota changes in patients with Metabolic dysfunction-Associated Fatty Liver Disease (MAFLD).\n\nResearch question: Are there any changes in metabolic profile, Insulin and TNF-α and gut microbiota changes in MAFLD patients after synbiotic supplementation\n\nParticipants will:\n\n* Treatment group given supplementation and the control group will be given placebo at a dose of 2x1 tablet for 12 weeks.\n* Patients will visit the hospital every 28 days for up to 4 months for control and follow-up supplementation.\n* patients will be given a supplement consumption compliance logbook and a food record logbook used to record food consumption filled in by the patient.",[88],"Fatty Liver Disease",[90,91,92,93],"Metabolic dysfunction-associated fatty liver disease","Gut Microbiota","Metabolic profile","Synbiotic","2024-11-07",{"date":96,"type":97},"2024-11-12","ACTUAL",{"date":99,"type":97},"2024-03-04",{"date":101,"type":82},"2025-03-07",{"name":5,"class":6},1]