lncRNAs as a Biomarker to Assess the Therapeutic Impact of Oral Absorbent ± Probiotics in CKD Patients With PAD

Launched by NATIONAL TAIWAN UNIVERSITY HOSPITAL · Mar 4, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring how a special treatment using activated bamboo charcoal, with or without probiotics, can help improve health in patients with chronic kidney disease (CKD) who also have a condition called peripheral artery disease (PAD). CKD patients often have harmful substances in their blood that can worsen their kidney function and heart health. The study aims to see if this treatment can enhance blood vessel function and overall health outcomes for these patients. Researchers are also interested in understanding if certain markers in the blood can help predict serious health issues in these patients.

To participate in this trial, you need to be over 20 years old and have CKD with specific kidney function levels, along with symptoms of PAD. Healthy individuals with normal kidney function may also be included as a comparison group. The study will last for six months, where participants will receive the treatment and undergo regular assessments to track their health progress. This trial is currently recruiting participants, and it's important to know that there are specific health conditions that may exclude someone from joining, such as severe kidney impairment or certain gastrointestinal issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • I: Patients
• • 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: Controls
• • 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.