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

Launched by NATIONAL TAIWAN UNIVERSITY HOSPITAL · Mar 9, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a combination of activated bamboo charcoal and probiotics on patients with chronic kidney disease (CKD) and peripheral artery disease (PAD). Researchers believe that these treatments may help improve health by affecting the gut bacteria and the way the body processes certain substances. The goal is to find new ways to identify patients at risk of serious health issues and to potentially develop better treatments to prevent complications related to heart and blood vessel health in these patients.

To participate in this study, individuals must be over 20 years old and have a stable form of CKD with specific kidney function measurements, as well as symptoms of PAD. Patients with more severe kidney issues or certain other health conditions will not be eligible. Participants will undergo tests to monitor their health and will receive the treatment being tested. This trial is currently recruiting and aims to explore how these treatments can improve kidney and vascular function and overall health outcomes in patients facing these challenging conditions.

Gender

ALL

Eligibility criteria

• 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.