What is activated bamboo charcoal studying for chronic kidney disease and peripheral artery disease?

This trial is studying how activated bamboo charcoal, with or without probiotics, may affect blood vessel health, heart outcomes, and survival in people with chronic kidney disease and peripheral artery disease. Researchers are also exploring biomarkers in the blood and gut that could predict risks of heart and limb problems. The study is sponsored by National Taiwan University Hospital.

Who may be eligible for this CKD and PAD clinical trial?

Adults aged 20 or older with chronic kidney disease and symptomatic peripheral artery disease may be eligible. The trial also includes healthy adults without PAD as controls. Participants should not have severe kidney failure, recent antibiotics or probiotics use, or major digestive diseases. Please review eligibility criteria for more details.

Is there any cost to participate in this CKD and PAD clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase Not Applicable

Age: 20Years +

All Genders

ID04788914

Assessing Oral Activated Bamboo Charcoal and Probiotics on Vascular and Kidney Health in Adults with Chronic Kidney Disease and Peripheral Arterial Disease

Led by National Taiwan University Hospital · Updated on 2025-07-17

180

Participants Needed

Research Sites

30 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying chronic kidney disease CKD patients who have a higher risk of developing peripheral artery disease PAD, a condition affecting blood flow in the limbs. The study aims to evaluate the effects of a carbon-based oral adsorbent made from activated bamboo charcoal ABC, with or without added probiotics, on vascular and endothelial function, cardiovascular outcomes, and mortality in these patients. They also plan to explore how circulating long noncoding RNA lncRNA and metabolome profiles may predict adverse cardiovascular events and death, while investigating the link between these biomarkers and gut microbiota imbalance in CKD patients with PAD. This is a randomized, open-label trial lasting 6 months, where 120 CKD patients with PAD and 60 healthy controls without PAD will be assigned to receive either the ABC treatment or no treatment. Participants in the treatment groups will take CharXenPlus containing 2g of ABC three times daily for 6 months. Additionally, probiotics will be given once daily during the last 3 months to some subgroups. Samples of urine, stool, and plasma will be collected and stored for further analysis. The trial includes detailed monitoring of kidney function, vascular health, and microbiota changes. Participants will undergo assessments at the start, at 3 months, and at 6 months, including tests such as the six-minute walk test and ankle-brachial index ABI. Researchers will also measure changes in lncRNA, microbiota composition, endothelial progenitor cells, kidney function eGFR, and albuminuria. The study will track cardiovascular, kidney, and limb health outcomes for up to 3 years. Privacy is protected by coded samples and data storage, with the option for participants to allow long-term storage of their samples for future research.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 20Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age over 20 years old on the day of screening.
For patients: Chronic kidney disease with an eGFR between 15 and 60 ml/min/1.73m2 in stable condition, with creatinine rising less than 0.3 mg/dL in the past 30 days.
For patients: Symptomatic peripheral artery disease with Rutherford Stage 2 or higher and ankle-brachial index less than 0.9 or documented by imaging.
For controls: Age over 20 years old on the day of screening.
For controls: eGFR greater than 60 ml/min/1.73m2.
For controls: No clinical peripheral artery disease.

You will not qualify if you...

Estimated glomerular filtration rate less than 15 ml/min/1.73m2.
Severe malnutrition with albumin less than 2.0 g/dL.
Severe anemia or active gastrointestinal bleeding with hemoglobin less than 8 g/dL.
Peptic ulcer, esophageal varices, ileus, or fasting status.
Previous gastrointestinal surgery.
Chronic constipation defined by less than 3 bowel movements per week with straining or incomplete evacuation, unless relieved by laxatives.
Recent major hemorrhage requiring blood transfusion.
Advanced liver cirrhosis, Child classification B or C.
Solid organ or blood transplantation recipients.
Oliguric kidney injury producing less than 500 cc urine per day.
Obstructive kidney injury or polycystic kidney disease.
Antibiotics or probiotics treatment within 2 weeks before enrollment or during follow-up.

Research Team

Chau chung Wu

Mei-Chang Huang

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Assessing Oral Activated Bamboo Charcoal and Probiotics on Vascular and Kidney Health in Adults with Chronic Kidney Disease and Peripheral Arterial Disease

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria