Actively Recruiting

Phase Not Applicable
Age: 20Years +
All Genders
NCT04792320

Oral Absorbent and Probiotics in CKD Patients With PAD on Gut Microbiota, IncRNA, Metabolome, and Vascular Function

Led by National Taiwan University Hospital · Updated on 2025-07-18

180

Participants Needed

1

Research Sites

514 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Taiwan has more chronic kidney disease (CKD) per capita than anywhere in the world, leading to the highest expense of National Health Insurance. By reviewing previous studies, uremic toxins contribute critically to the detrimental effects of CKD on atherosclerotic peripheral artery disease (PAD). When recognized early and managed appropriately, mortality and complications of the participants with CKD and established PAD can be minimized. It is critical to identify novel biomarkers and mediators, which can help identify those with potential poor outcomes and facilitate the discovery/development of novel therapeutics for the patients with CKD and PAD. The OMICs studies support the theory that gut microbiome is a major contributor to adverse cardiovascular outcomes and progression of CKD. However, successful integration of multi-omics approach remains sparse. There is no report on the impact of gut microbiota on the host circulating long non-coding RNAs (lncRNAs) expression signature, other CAD/PAD potential marker, and the potential link between gut microbiota, circulating lncRNA levels changes and CKD/PAD. Additionally, although numerous studies indicated that probiotics or activated charcoal have benefits for CKD patients, few studies evaluated the effect of coadministration of activated charcoal/probiotics on the patients with CKD/PAD. The mechanisms of therapeutic effect on CKD/PAD patients with coadministration of activated charcoal/probiotics involving the cross talk among host, microbiota and metabolites still remain unclear. Thus, in the present study, investigators aim to develop novel diagnostic/prognostic markers and a new treatment with activated bamboo charcoal (ABC)/probiotics for therapeutic opportunities to prevent cardiovascular complications, amputation and death in CKD patients with established PAD. To identify the diagnostic/prognostic markers, the multi-omics (microbolome and metabolome) and lncRNA will be analyzed. The therapeutic impact of activated bamboo charcoal (ABC)/probiotics with optimal formulation, on the renal/endothelial/vascular function, cardiovascular (CV) outcome and mortality in CKD patients with PAD will be also determined to evaluate its therapeutic opportunities.

CONDITIONS

Official Title

Oral Absorbent and Probiotics in CKD Patients With PAD on Gut Microbiota, IncRNA, Metabolome, and Vascular Function

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 20 years on the day of screening
  • For CKD/PAD group: CKD patients with eGFR between 15 and 60 ml/min/1.73m2 in stable condition
  • Creatinine rise less than 0.3 mg/dL in the 30 days before enrollment
  • Symptomatic peripheral artery disease with Rutherford Stage 2 or higher and ankle-brachial index (ABI) 0.9 or less
  • For non-CKD/PAD group: Age over 20 years
  • eGFR greater than 60 ml/min/1.73m2
  • No clinical peripheral artery disease
Not Eligible

You will not qualify if you...

  • 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 as fewer than 3 bowel movements per week with symptoms
  • Major acute hemorrhage requiring blood transfusion
  • Advanced liver cirrhosis classified as Child B or C
  • Solid organ or blood transplant recipients
  • Oliguric kidney injury with urine output less than 500 cc/day
  • Obstructive kidney injury or polycystic kidney disease
  • Antibiotics or probiotics use within 2 weeks before enrollment or during follow-up
  • History or presence of cancer within 5 years prior to screening
  • Acquired Immune Deficiency Syndrome
  • Recent acute coronary syndrome, myocardial infarction, or severe heart failure

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

NTUH

Taipei, Taiwan

Actively Recruiting

Loading map...

Research Team

C

Chau chung Wu

CONTACT

M

Mei-Chang Huang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

4

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here