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Oral Absorbent and Probiotics in CKD Patients With PAD on Gut Microbiota, IncRNA, Metabolome, and Vascular Function

RecruitingNAAges 20 Years - anyAllNational Taiwan University Hospital
NCT04792320 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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/development 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 impac

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📋 Eligibility rules (as published)
Inclusion Criteria: I. CKD/PAD group Patients (Group I) 1. Age \> 20 years old on the day of screening. 2. CKD patients with eGFR 15 \< eGFR \< 60 ml/min/1.73m2 in a stable status, creatinine elevated less than 0.3 mg/dL in at least 30 days before enrollment. 3. Symptomatic PAD with Rutherford Stage ≥ 2 and ABI ≤ 0.9 (or documented by CT-angio, vascular duplex, etc.). II. non-CKD/PAD group Patients (Group II) 1\. Age \> 20 years old on the day of screening. 2.With eGFR \> 60 ml/min/1.73m2 3.No clinical PAD. Exclusion Criteria: 1. Baseline estimated glomerular filtration rates (eGFR) \< 15 ml/min/1.73m2 according to MDRD equation. 2. Patients in severe malnutrition status, albumin less than 2.0 g/dL 3. Patients in severe anemia or active gastrointestinal bleeding with hemoglobulin \< 8 g/dL. 4. Peptic ulcer, esophageal varices, ileus or under fasting status 5. Previous gastrointestinal operation. 6. 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. 7. Patients with major hemorrhage, as defined with acute hemorrhage and requirement of blood transfusion during index admission. 8. Patients with a biopsy proved or clinically diagnosed advanced liver cirrhosis, Child classification B or C. 9. Solid organ or hematological transplantation recipients. 10. Patients with oliguric kidney injury, as defined with less than 500 cc/day. 11. Evidence of obstructive kidney injury or polycystic kidney disease. 12. Antibiotics or probiotics treatment within the last 2 weeks before enrollment and during follow-up period. 13. Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. 14. Patients with Acquired Immune Deficiency Syndrome. 15. Patients with recent acute coronary syndrome, acute myocardial infarction, or severe heart failure.
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What it tests

  • Active bamboo charcoal
  • probiotics
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Where

1 site
NTUH
Taipei, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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