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

Circulating Long Noncoding RNA as a Biomarker to Assess the Therapeutic Impact of Oral Uremic Toxin Absorbent ± Probiotics in Chronic Kidney Disease Patients With Peripheral Arterial Disease

This study tests whether taking bamboo charcoal with or without probiotics can help improve kidney and blood vessel health in people with chronic kidney disease and peripheral artery disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: National Taiwan University Hospital (Academic / other)
• Locations: 1 site (Taipei, Taiwan)
• Trial ID: NCT04788914 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults over 20 years old with stable CKD (eGFR between 15 and 60 ml/min/1.73m2) and symptomatic PAD.

Not a fit: Patients with severe malnutrition, severe anemia, or those with eGFR below 15 ml/min/1.73m2 will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve vascular health and slow the progression of kidney disease in affected patients.

How similar studies have performed: While the use of oral absorbents in CKD has shown promise, this specific approach combining bamboo charcoal and probiotics is novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Taipei, Taiwan

• Ntuh — Taipei, Taiwan, Taiwan (Recruiting)

Study contacts

• Principal investigator: Chau chung Wu — National Taiwan University Hospital
• Study coordinator: Chau chung Wu

Conditions CKD; PAD; Bamboo charcoal; LncRNA; gut microbiota; Probiotics