- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04792320
Oral Absorbent and Probiotics in CKD Patients With PAD on Gut Microbiota, IncRNA, Metabolome, and Vascular Function
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chau chung Wu
- Phone Number: 88560 02-23123456
- Email: Chauchungwu@ntu.edu.tw
Study Contact Backup
- Name: Mei-Chang Huang
- Phone Number: 88559 02-23123456
- Email: r204.cc01@gmail.com
Study Locations
-
-
-
Taipei, Taiwan
- Recruiting
- NTUH
-
Contact:
- Mei-Chen Huang, master
- Phone Number: 885589 02-23123456
- Email: r204.cc01@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
I. 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active bamboo charcoal
Eligible 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. |
4g particle
Other Names:
|
Experimental: Probiotics
Eligible 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. |
0.8g powder
Other Names:
|
Experimental: Active bamboo charcoal+Probiotics
Eligible 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. |
4g particle
Other Names:
0.8g powder
Other Names:
|
No Intervention: No invervention
Eligible 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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The change of 6-minute walking distance
Time Frame: baseline, 3rd month, 6th month, 1st year, 2nd year and 3rd year
|
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.
|
baseline, 3rd month, 6th month, 1st year, 2nd year and 3rd year
|
The change of ABI
Time Frame: baseline, 3rd month, 6th month, 1st year, 2nd year and 3rd year
|
The ABI value is determined by taking the higher pressure of the 2 arteries at the ankle, divided by the brachial arterial systolic pressure.
|
baseline, 3rd month, 6th month, 1st year, 2nd year and 3rd year
|
The change of vascular duplex
Time Frame: baseline, 3rd month, 6th month, 1st year, 2nd year and 3rd year
|
Duplex ultrasound of peripheral artery
|
baseline, 3rd month, 6th month, 1st year, 2nd year and 3rd year
|
The change of serum lncRNA
Time Frame: baseline, 3rd month, 6th month, 1st year, 2nd year and 3rd year
|
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.
|
baseline, 3rd month, 6th month, 1st year, 2nd year and 3rd year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Chau chung Wu, National Taiwan University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202002127RINC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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