Actively Recruiting
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
Led by National Taiwan University Hospital · Updated on 2025-07-18
180
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on patients with chronic kidney disease (CKD) and peripheral arterial disease (PAD), conditions that cause serious health issues and high medical costs in Taiwan. Researchers aim to identify new diagnostic and prognostic markers by analyzing gut microbiome, metabolome, and circulating long non-coding RNAs. The study also explores how these markers relate to the progression and complications of CKD and PAD, especially concerning cardiovascular risks and limb outcomes. Participants are divided into groups, with some receiving activated bamboo charcoal (ABC) combined with probiotics and others receiving no treatment. ABC is given as 4g particles containing 2g of charcoal three times daily for six months. Probiotics are administered as 0.8g powder once daily during the last three months of treatment, except for specific subgroups. This design allows evaluation of the therapeutic effects of ABC and probiotics on kidney, vascular, and cardiovascular health. During the study, participants will undergo assessments including changes in 6-minute walking distance, ankle-brachial index (ABI), vascular duplex ultrasound, and serum long non-coding RNA levels at baseline, 3 months, 6 months, and annually up to 3 years. Researchers will monitor the impact on renal function, vascular health, cardiovascular events, and mortality. This comprehensive approach combines molecular biology and clinical research to improve care and outcomes for CKD patients with PAD.
CONDITIONS
Brief Title
Oral Absorbent and Probiotics in CKD Patients With PAD on Gut Microbiota, IncRNA, Metabolome, and Vascular Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 20 years on the day of screening
- For CKD/PAD group: CKD patients with stable eGFR between 15 and 60 ml/min/1.73m2 and creatinine elevation less than 0.3 mg/dL in the last 30 days
- Symptomatic peripheral arterial disease with Rutherford Stage 2 or higher and ankle-brachial index 0.9 or less (or documented by imaging)
- For non-CKD/PAD group: Age over 20 years, eGFR greater than 60 ml/min/1.73m2, and no clinical PAD
You will not qualify if you...
- Estimated glomerular filtration rate (eGFR) 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 associated symptoms, unless controlled by oral laxatives
- Major hemorrhage requiring blood transfusion
- Advanced liver cirrhosis (Child B or C)
- Solid organ or blood cell transplant 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
- History or presence of malignant cancers within 5 years
- Acquired Immune Deficiency Syndrome
- Recent acute coronary syndrome, heart attack, or severe heart failure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive active bamboo charcoal and/or probiotics according to their assigned group to evaluate their therapeutic impact on kidney and vascular function.
Visits at baseline, 3 months, and 6 months for assessments
Duration - Up to 3 years after treatment
Participants are monitored for long-term changes in walking distance, vascular function, and biomarkers up to 3 years after treatment.
Visits at 1 year, 2 years, and 3 years post-treatment
Trial Site Locations
Total: 1 location
1
NTUH
Taipei, Taiwan
Actively Recruiting
Research Team
C
Chau chung Wu
M
Mei-Chang Huang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
4
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