[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100423320":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":39,"centralContacts":43,"locations":53,"responsibleParty":72,"collaborators":25,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":25,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":25,"enrollmentInfo":83,"targetDuration":25,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":56,"whyStopped":25,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"National Taiwan University Hospital","OTHER",[8,14,19,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Active bamboo charcoal","EXPERIMENTAL","Eligible 120 participants (group I),The other 60 eligible controls (group II) will be also randomized into ABC-treatment (A) or no-treatment (B) with a 1:1 ratio. The participants will receive CharXenPlus 4g particles ( containing ABC 2g) thrice daily for 6 months in subgroups IA and IIA.\n\nWhile the patients in subgroups IB and IIB will not receive any ABC. The subgroups IA and IB will be further randomly subdivided into IAa, IAb, IBa, and IBb subsubgroups.\n\nAll the patients will receive probiotics APL-MIX2 (CharXprob) 0.8 g powder once a day in the last 3 months except those in subsubgroups IAb and IBb.",[13],"Dietary Supplement: Active bamboo charcoal",{"label":15,"type":10,"description":16,"interventionNames":17},"Probiotics","Eligible 120 participants (group I),The other 60 eligible controls (group II) will be also randomized into ABC-treatment (A) or no-treatment (B) with a 1:1 ratio. The patients will receive CharXenPlus 4g particles ( containing ABC 2g) thrice daily for 6 months in subgroups IA and IIA.\n\nWhile the patients in subgroups IB and IIB will not receive any ABC. The subgroups IA and IB will be further randomly subdivided into IAa, IAb, IBa, and IBb subsubgroups.\n\nAll the patients will receive probiotics APL-MIX2 (CharXprob) 0.8 g powder once a day in the last 3 months except those in subsubgroups IAb and IBb.",[18],"Dietary Supplement: probiotics",{"label":20,"type":10,"description":16,"interventionNames":21},"Active bamboo charcoal+Probiotics",[13,18],{"label":23,"type":24,"description":16,"interventionNames":25},"No invervention","NO_INTERVENTION",null,[27,33],{"type":28,"name":9,"description":29,"armGroupLabels":30,"otherNames":31},"DIETARY_SUPPLEMENT","4g particle",[9,20],[32],"CharXenPlus",{"type":28,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"probiotics","0.8g powder",[20,15],[38],"Charxprob",[40],{"name":41,"affiliation":5,"role":42},"Chau chung Wu","PRINCIPAL_INVESTIGATOR",[44,49],{"name":41,"role":45,"phone":46,"phoneExt":47,"email":48},"CONTACT","02-23123456","88560","Chauchungwu@ntu.edu.tw",{"name":50,"role":45,"phone":46,"phoneExt":51,"email":52},"Mei-Chang Huang","88559","r204.cc01@gmail.com",[54],{"facility":55,"status":56,"city":57,"state":25,"zip":25,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"NTUH","RECRUITING","Taipei","Taiwan","TW",{"type":61,"coordinates":62},"Point",[63,64],121.52639,25.05306,{"lat":64,"lon":63},[67,69],{"name":68,"role":45,"phone":46,"phoneExt":47,"email":48},"Chau chung Wu, PhD",{"name":70,"role":45,"phone":46,"phoneExt":71,"email":52},"Mei-Chen Huang, master","885589",{"type":73,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100423320","oral-absorbent-and-probiotics-in-ckd-patients-with-pad-on-gut-microbiota-incrna-metabolome-and-vascular-function-100423320",false,"NCT04792320","Oral Absorbent and Probiotics in CKD Patients With PAD on Gut Microbiota, IncRNA, Metabolome, and Vascular Function","Therapeutic Impact of Oral Uremic Toxin Absorbent and Probiotics in Chronic Kidney Disease Patients With Peripheral Arterial Disease--- on Gut Microbiota, Circulating Long Noncoding RNA, Metabolome, and Vascular Function","Inclusion Criteria:\n\nI. CKD\u002FPAD group Patients (Group I)\n\n1. Age \\> 20 years old on the day of screening.\n2. CKD patients with eGFR 15 \\\u003C eGFR \\\u003C 60 ml\u002Fmin\u002F1.73m2 in a stable status, creatinine elevated less than 0.3 mg\u002FdL in at least 30 days before enrollment.\n3. Symptomatic PAD with Rutherford Stage ≥ 2 and ABI ≤ 0.9 (or documented by CT-angio, vascular duplex, etc.). II. non-CKD\u002FPAD group Patients (Group II)\n\n1\\. Age \\> 20 years old on the day of screening. 2.With eGFR \\> 60 ml\u002Fmin\u002F1.73m2 3.No clinical PAD.\n\nExclusion Criteria:\n\n1. Baseline estimated glomerular filtration rates (eGFR) \\\u003C 15 ml\u002Fmin\u002F1.73m2 according to MDRD equation.\n2. Patients in severe malnutrition status, albumin less than 2.0 g\u002FdL\n3. Patients in severe anemia or active gastrointestinal bleeding with hemoglobulin \\\u003C 8 g\u002FdL.\n4. Peptic ulcer, esophageal varices, ileus or under fasting status\n5. Previous gastrointestinal operation.\n6. Chronic constipation, as defined with less than 3 bowel movements per week, straining, hard stools, incomplete evacuation and inability to pass stool. If usage of oral laxatives can achieve bowel movement, this patient will not be excluded.\n7. Patients with major hemorrhage, as defined with acute hemorrhage and requirement of blood transfusion during index admission.\n8. Patients with a biopsy proved or clinically diagnosed advanced liver cirrhosis, Child classification B or C.\n9. Solid organ or hematological transplantation recipients.\n10. Patients with oliguric kidney injury, as defined with less than 500 cc\u002Fday.\n11. Evidence of obstructive kidney injury or polycystic kidney disease.\n12. Antibiotics or probiotics treatment within the last 2 weeks before enrollment and during follow-up period.\n13. Presence or history of malignant neoplasms within the past 5 years prior to the day of screening.\n14. Patients with Acquired Immune Deficiency Syndrome.\n15. Patients with recent acute coronary syndrome, acute myocardial infarction, or severe heart failure.","ALL","20 Years",{"count":84,"type":85},180,"ESTIMATED","INTERVENTIONAL",[88],"NA","Taiwan has more chronic kidney disease (CKD) per capita than anywhere in the world, leading to the highest expense of National Health Insurance. By reviewing previous studies, uremic toxins contribute critically to the detrimental effects of CKD on atherosclerotic peripheral artery disease (PAD). When recognized early and managed appropriately, mortality and complications of the participants with CKD and established PAD can be minimized. It is critical to identify novel biomarkers and mediators, which can help identify those with potential poor outcomes and facilitate the discovery\u002Fdevelopment of novel therapeutics for the patients with CKD and PAD. The OMICs studies support the theory that gut microbiome is a major contributor to adverse cardiovascular outcomes and progression of CKD. However, successful integration of multi-omics approach remains sparse. There is no report on the impact of gut microbiota on the host circulating long non-coding RNAs (lncRNAs) expression signature, other CAD\u002FPAD potential marker, and the potential link between gut microbiota, circulating lncRNA levels changes and CKD\u002FPAD. Additionally, although numerous studies indicated that probiotics or activated charcoal have benefits for CKD patients, few studies evaluated the effect of coadministration of activated charcoal\u002Fprobiotics on the patients with CKD\u002FPAD. The mechanisms of therapeutic effect on CKD\u002FPAD patients with coadministration of activated charcoal\u002Fprobiotics involving the cross talk among host, microbiota and metabolites still remain unclear. Thus, in the present study, investigators aim to develop novel diagnostic\u002Fprognostic markers and a new treatment with activated bamboo charcoal (ABC)\u002Fprobiotics for therapeutic opportunities to prevent cardiovascular complications, amputation and death in CKD patients with established PAD. To identify the diagnostic\u002Fprognostic markers, the multi-omics (microbolome and metabolome) and lncRNA will be analyzed. The therapeutic impact of activated bamboo charcoal (ABC)\u002Fprobiotics with optimal formulation, on the renal\u002Fendothelial\u002Fvascular function, cardiovascular (CV) outcome and mortality in CKD patients with PAD will be also determined to evaluate its therapeutic opportunities.",[91,92],"CKD","PAD - Peripheral Arterial Disease",[91,92,94,95,96,97,34],"bamboo charcoal probiotics","LncRNA","microbolomics","metabolomics","2025-07-16",{"date":100,"type":101},"2025-07-18","ACTUAL",{"date":103,"type":101},"2020-06-19",{"date":105,"type":85},"2030-04-30",{"name":5,"class":6},1]