AzTrials
AzTrials

CKDNCT04792320

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

A study testing Active bamboo charcoal and probiotics in people with CKD and PAD - Peripheral Arterial Disease, run by National Taiwan University Hospital at 1 site in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
CKD, PAD - Peripheral Arterial Disease
What is being tested?
Active bamboo charcoal and probiotics
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteTaiwan
Study dates
19 Jun 2020to 30 Apr 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • CKD/PAD group Patients (Group I)
  • Age > 20 years old on the day of screening.
  • 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.
  • 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.

Who cannot join

  • Baseline estimated glomerular filtration rates (eGFR) < 15 ml/min/1.73m2 according to MDRD equation.
  • Patients in severe malnutrition status, albumin less than 2.0 g/dL
  • Patients in severe anemia or active gastrointestinal bleeding with hemoglobulin < 8 g/dL.
  • Peptic ulcer, esophageal varices, ileus or under fasting status
  • Previous gastrointestinal operation.
  • 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.
Show all 15Show fewer
  • Patients with major hemorrhage, as defined with acute hemorrhage and requirement of blood transfusion during index admission.
  • Patients with a biopsy proved or clinically diagnosed advanced liver cirrhosis, Child classification B or C.
  • Solid organ or hematological transplantation recipients.
  • Patients with oliguric kidney injury, as defined with less than 500 cc/day.
  • Evidence of obstructive kidney injury or polycystic kidney disease.
  • Antibiotics or probiotics treatment within the last 2 weeks before enrollment and during follow-up period.
  • Presence or history of malignant neoplasms within the past 5 years prior to the day of screening.
  • Patients with Acquired Immune Deficiency Syndrome.
  • Patients with recent acute coronary syndrome, acute myocardial infarction, or severe heart failure.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Taiwan1 site, 1 recruiting
  • NTUH

    Taipei

    Chau chung Wu, PhD, 02-23123456 ext. 88560, Chauchungwu@ntu.edu.tw

    Mei-Chen Huang, master, 02-23123456 ext. 885589, r204.cc01@gmail.com

    Recruiting

Other trials in Taiwan

About this study

Official title: 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

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.

Read the detailed description

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 participants 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 participants 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. Additionally, the possible mechanisms including the molecular pathway and the roles of microbiota associated with expression profiles of lncRNA and metabolome linked to adverse CV/limb outcome will be investigation. Through combination of innovative molecular biological techniques with new approaches for clinical research, investigators will develop a novel therapy by updated knowledge of the mechanisms of disease and by improved pharmacological technology for the CKD patients with established PAD. Investigators expect to demonstrate the clinical efficacy of ABC ± probiotics to improve symptoms and outcomes of CKD patients with PAD, and offer a possibility to develop a precision medicine with novel diagnostic/prognostic markers and special ABC/probiotic formula, which will ultimately lead to the improved clinical care and outcomes in this population.

Being tested
Active bamboo charcoal, probiotics
Keywords
CKD, PAD - Peripheral Arterial Disease, bamboo charcoal probiotics, LncRNA, microbolomics, metabolomics, probiotics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active bamboo charcoalDietary supplement

    Also called CharXenPlus

    4g particle

  • probioticsDietary supplement

    Also called Charxprob

    0.8g powder

Study groups in NCT04792320
Study groupRoleWhat they receive
Active bamboo charcoalExperimentalEligible 120 participants (group I),The other 60 eligible controls (group II) will be also randomized into ABC-treatment (A) or no-treatment (B) with a 1:1 ratio. The participants will receive CharXenPlus 4g particles ( containing ABC 2g) thrice daily for 6 months in subgroups IA and IIA. While the patients in subgroups IB and IIB will not receive any ABC. The subgroups IA and IB will be further randomly subdivided into IAa, IAb, IBa, and IBb subsubgroups. All the patients will receive probiotics APL-MIX2 (CharXprob) 0.8 g powder once a day in the last 3 months except those in subsubgroups IAb and IBb.
Receives: Dietary Supplement: Active bamboo charcoal
ProbioticsExperimentalEligible 120 participants (group I),The other 60 eligible controls (group II) will be also randomized into ABC-treatment (A) or no-treatment (B) with a 1:1 ratio. The patients will receive CharXenPlus 4g particles ( containing ABC 2g) thrice daily for 6 months in subgroups IA and IIA. While the patients in subgroups IB and IIB will not receive any ABC. The subgroups IA and IB will be further randomly subdivided into IAa, IAb, IBa, and IBb subsubgroups. All the patients will receive probiotics APL-MIX2 (CharXprob) 0.8 g powder once a day in the last 3 months except those in subsubgroups IAb and IBb.
Receives: Dietary Supplement: probiotics
Active bamboo charcoal+ProbioticsExperimentalEligible 120 participants (group I),The other 60 eligible controls (group II) will be also randomized into ABC-treatment (A) or no-treatment (B) with a 1:1 ratio. The patients will receive CharXenPlus 4g particles ( containing ABC 2g) thrice daily for 6 months in subgroups IA and IIA. While the patients in subgroups IB and IIB will not receive any ABC. The subgroups IA and IB will be further randomly subdivided into IAa, IAb, IBa, and IBb subsubgroups. All the patients will receive probiotics APL-MIX2 (CharXprob) 0.8 g powder once a day in the last 3 months except those in subsubgroups IAb and IBb.
Receives: Dietary Supplement: Active bamboo charcoal; Dietary Supplement: probiotics
No inverventionNo interventionEligible 120 participants (group I),The other 60 eligible controls (group II) will be also randomized into ABC-treatment (A) or no-treatment (B) with a 1:1 ratio. The patients will receive CharXenPlus 4g particles ( containing ABC 2g) thrice daily for 6 months in subgroups IA and IIA. While the patients in subgroups IB and IIB will not receive any ABC. The subgroups IA and IB will be further randomly subdivided into IAa, IAb, IBa, and IBb subsubgroups. All the patients will receive probiotics APL-MIX2 (CharXprob) 0.8 g powder once a day in the last 3 months except those in subsubgroups IAb and IBb.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The change of 6-minute walking distance

    The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.

    Measured: baseline, 3rd month, 6th month, 1st year, 2nd year and 3rd year

  2. The change of ABI

    The ABI value is determined by taking the higher pressure of the 2 arteries at the ankle, divided by the brachial arterial systolic pressure.

    Measured: baseline, 3rd month, 6th month, 1st year, 2nd year and 3rd year

  3. The change of vascular duplex

    Duplex ultrasound of peripheral artery

    Measured: baseline, 3rd month, 6th month, 1st year, 2nd year and 3rd year

  4. The change of serum lncRNA

    Long non-coding RNAs (long ncRNAs, lncRNA) are a type of RNA, defined as being transcripts with lengths exceeding 200 nucleotides that are not translated into protein.

    Measured: baseline, 3rd month, 6th month, 1st year, 2nd year and 3rd year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2021
  2. Study start19 Jun 2020
  3. Primary completion30 Apr 2030 (estimated)
  4. Study completion30 Apr 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04792320
Sponsor's protocol ID
202002127RINC
Status last verified
Jul 2025
First submitted
19 May 2020
Last updated
18 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Active bamboo charcoal and probiotics in people with CKD and PAD - Peripheral Arterial Disease, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chau chung Wu (02-23123456 ext. 88560, Chauchungwu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change of 6-minute walking distance (time frame: baseline, 3rd month, 6th month, 1st year, 2nd year and 3rd year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in