[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100485210":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":42,"responsibleParty":107,"collaborators":25,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":119,"sex":120,"minAge":121,"maxAge":122,"enrollmentInfo":123,"targetDuration":25,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":133,"overallStatus":45,"whyStopped":25,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Chinese Academy of Medical Sciences, Fuwai Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"FMT capsules","EXPERIMENTAL","FMT capsules containing extensively screened donor stool. FMT capsules will be orally taken on week 0, week 4, week 8, week 12, week 24, week 28, week 32, week 36, week 48, week 52, week 56, week 60, week 72, week 76, week 80, week 84.",[13],"Biological: FMT capsules",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo capsules","PLACEBO_COMPARATOR","Placebo capsules that do not contain donor stool or any active drug. Placebo capsules will be orally taken on week 0, week 4, week 8, week 12, week 24, week 28, week 32, week 36, week 48, week 52, week 56, week 60, week 72, week 76, week 80, week 84.",[19],"Other: Placebo capsules",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","FMT capsules containing extensively screened donor stool.",[9],null,{"type":6,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Placebo capsules that do not contain donor stool or any active drug.",[15],[30],{"name":31,"affiliation":32,"role":33},"Jun Cai, MD,PhD","Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases, Chinese Institutes for Medical Research","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Luyun Fan, MD,PhD","CONTACT","01081992131","katevan@163.com",{"name":31,"role":37,"phone":25,"phoneExt":25,"email":41},"caijun7879@126.com",[43,59,67,75,83,95],{"facility":44,"status":45,"city":46,"state":47,"zip":25,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Beijing Chao-yang Hospital, Capital Medical University","RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":51,"coordinates":52},"Point",[53,54],116.39723,39.9075,{"lat":54,"lon":53},[57],{"name":58,"role":37,"phone":25,"phoneExt":25,"email":25},"Yifan Fan, MD",{"facility":60,"status":45,"city":46,"state":47,"zip":25,"country":48,"countryCode":49,"cosmosGeoPoint":61,"geoPoint":63,"contacts":64},"Beijing Hospital",{"type":51,"coordinates":62},[53,54],{"lat":54,"lon":53},[65],{"name":66,"role":37,"phone":25,"phoneExt":25,"email":25},"Ni Zhang, MD",{"facility":68,"status":45,"city":46,"state":47,"zip":25,"country":48,"countryCode":49,"cosmosGeoPoint":69,"geoPoint":71,"contacts":72},"Chinese People's Liberation Army (PLA) General Hospital",{"type":51,"coordinates":70},[53,54],{"lat":54,"lon":53},[73],{"name":74,"role":37,"phone":25,"phoneExt":25,"email":25},"Guogang Xu, MD",{"facility":76,"status":45,"city":46,"state":47,"zip":25,"country":48,"countryCode":49,"cosmosGeoPoint":77,"geoPoint":79,"contacts":80},"Xuanwu Hospital, Capital Medical University",{"type":51,"coordinates":78},[53,54],{"lat":54,"lon":53},[81],{"name":82,"role":37,"phone":25,"phoneExt":25,"email":25},"Jing Li, MD",{"facility":84,"status":45,"city":85,"state":86,"zip":25,"country":48,"countryCode":49,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Huadong Hospital Affiliated to Fudan University","Shanghai","Shanghai Municipality",{"type":51,"coordinates":88},[89,90],121.45806,31.22222,{"lat":90,"lon":89},[93],{"name":94,"role":37,"phone":25,"phoneExt":25,"email":25},"Kailei Shi, MD",{"facility":96,"status":45,"city":97,"state":98,"zip":25,"country":48,"countryCode":49,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Zhejiang Hospital","Hangzhou","Zhejiang",{"type":51,"coordinates":100},[101,102],120.16142,30.29365,{"lat":102,"lon":101},[105],{"name":106,"role":37,"phone":25,"phoneExt":25,"email":25},"Wei Yu, MD",{"type":33,"investigatorFullName":108,"investigatorTitle":109,"investigatorAffiliation":110,"oldNameTitle":25,"oldOrganization":25},"Jun Cai","Director","Beijing Anzhen Hospital","100485210","early-phase-1-effect-of-gut-microbiome-intervention-on-aging-via-oral-fmt-100485210",false,"NCT05598112","Effect of Gut Microbiome Intervention on Aging Via Oral FMT","Effect of Fecal Microbiota Transplantation on Aging and the Underlying Mechanism of Gut Microbiome Restoration: a Randomized Clinical Trial","STEP-aging","Inclusion Criteria:\n\n1. Age 70-85 years.\n2. Patients with informed consent after thorough explanation.\n\nExclusion Criteria:\n\n1. Participants of other clinical trials;\n2. Antibiotics or probiotics usage within last 4 weeks;\n3. Severe hepatic or renal diseases ((ALT \\>3 times the upper limit of normal value, or end stage renal disease on dialysis or eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2, or serum creatinine \\>2.5 mg\u002Fdl \\[\\>221 μmol\u002FL\\]);\n4. History of large atherosclerotic cerebral infarction or hemorrhagic stroke (not including lacunar infarction and transient ischemic attack \\[TIA\\]);\n5. Hospitalization for myocardial infarction within last 6 months; Coronary revascularization (PCI or CABG) within last 12 months; Planned for PCI or CABG in the next 6 months;\n6. NYHA class III-IV heart failure; Hospitalization for chronic heart failure exacerbation within last 6 months;\n7. Severe valvular diseases; Potential for surgery or percutaneous valve replacement within the study period;\n8. Dilated cardiomyopathy; Hypertrophic cardiomyopathy; Rheumatic heart disease; Congenital heart disease;\n9. History of dementia, Parkinson's disease, intracranial infection, intracranial tumor, schizophrenia, anxiety, depression;\n10. History of neurosurgical operation;\n11. History of gastrointestinal tumor, gastrointestinal surgery, inflammatory bowel disease; Hospitalization for peptic ulcer disease exacerbation within last 6 months or anticipated hospitalization for peptic ulcer disease the next 6 months;\n12. Hypertension with uncontrolled blood pressure ≥180\u002F110mmHg;\n13. Diabetes Mellitus with uncontrolled fasting glucose level ≥200mg\u002Fdl (11.1mmol\u002FL), or HbA1C\\>8%;\n14. Addicted to alcohol; Use of medication influencing cognitive function(i.e., antihistamine, antipsychotic);\n15. General anesthesia within last 3 months;\n16. Other severe diseases influencing the entry or survival of participants, such as malignant tumor or acquired immune deficiency syndrome, life expectancy \\\u003C1 year;\n17. Impaired verbal communication who are incapable of providing their own informed consent, or incapable of self-care;\n18. Special diet influencing microbiota (i.e. vegetarian);\n19. Other conditions inappropriate for recruitment according to the investigators.",true,"ALL","70 Years","85 Years",{"count":124,"type":125},210,"ESTIMATED","INTERVENTIONAL",[128],"EARLY_PHASE1","A severe public health issue facing global population is aging. Increasing preclinical and clinical data indicate the contribution of gut microbiome on aging and aging-related diseases such as cardiovascular disease, Alzheimer Disease, and diabetes. Interventions on microbiota are developed including prebiotics, probiotics, and fecal microbial transplantation (FMT). FMT via oral capsules also advances in recent with limited safety concerns compared with invasive routes. A hypothesis is thus raised that gut microbiome intervention via oral FMT can be a potential safe approach to encourage healthy aging, with multiple aspects evaluated for clinical phenotype of frailty, anthropometric measurement, cognitive function, cardiovascular aging, physical function, living activity, hippocampal volume, telomere length, cognitive biomarkers, inflammatory biomarkers, altered microbial composition and metabolites.",[131,132],"Aging","Frailty",[131,132,134,135,136],"Microbiome","Treatment","Fecal Microbiota Transplantation","2025-12-24",{"date":139,"type":140},"2025-12-31","ACTUAL",{"date":142,"type":140},"2023-04-24",{"date":144,"type":125},"2027-12-31",{"name":5,"class":6},6]