Using bamboo charcoal and probiotics to improve kidney and vascular health in patients with chronic kidney disease and peripheral artery disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of an activated bamboo charcoal oral absorbent, with or without probiotics, on patients suffering from chronic kidney disease (CKD) and symptomatic peripheral artery disease (PAD). The study aims to assess whether this treatment can enhance endothelial and vascular function, improve cardiovascular outcomes, and potentially delay the progression of CKD. Participants will be randomly assigned to receive either the treatment or a control, and their health will be monitored over a six-month period. The trial includes both CKD patients and healthy controls for comparison.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ntuh
  Taipei, Taiwan, Taiwan Recruiting

Study contacts

• Principal investigator: Chau chung Wu — National Taiwan University Hospital
• Study coordinator: Chau chung Wu
• Email: Chauchungwu@ntu.edu.tw
• Phone: 02-23123456

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.