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

Therapeutic Impact of Oral Uremic Toxin Absorbent and Probiotics in Chronic Kidney Disease Patients With Peripheral Arterial Disease--- on Gut Microbiota, Circulating Long Noncoding RNA, Metabolome, and Vascular Function

This study is testing whether bamboo charcoal and 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)
• Trial ID: NCT04792320 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of bamboo charcoal and probiotics on patients suffering from chronic kidney disease (CKD) and peripheral artery disease (PAD). It aims to explore how these interventions can influence gut microbiota, long non-coding RNAs (lncRNAs), and metabolic profiles, potentially leading to improved vascular function and health outcomes. The study will include patients with stable CKD and symptomatic PAD, assessing various biomarkers and mediators to identify those at risk of poor outcomes. By integrating a multi-omics approach, the research seeks to uncover novel therapeutic strategies for managing these conditions.

Who should consider this trial

Good fit: Ideal candidates for this study 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 CKD (eGFR less than 15 ml/min/1.73m2) or those with significant gastrointestinal issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new treatment options that improve kidney function and vascular health for patients with CKD and PAD.

How similar studies have performed: While there have been studies on probiotics and activated charcoal for CKD patients, this specific multi-omics approach is relatively novel and has not been extensively tested.

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.

Where this trial is running

Taipei

• Ntuh — Taipei, Taiwan (Recruiting)

Study contacts

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

Conditions CKD; PAD - Peripheral Arterial Disease; bamboo charcoal probiotics; LncRNA; microbolomics; metabolomics; probiotics