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 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.

Why it matters

Who can join: the full rules

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 it's running

• Ntuh
  Taipei, 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.