Status:
RECRUITING
Oral Absorbent and Probiotics in CKD Patients With PAD on Gut Microbiota, IncRNA, Metabolome, and Vascular Function
Lead Sponsor:
National Taiwan University Hospital
Conditions:
CKD
PAD - Peripheral Arterial Disease
Eligibility:
All Genders
20+ years
Phase:
NA
Brief 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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2030
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04792320
Start Date
June 19 2020
End Date
April 30 2030
Last Update
July 18 2025
Active Locations (1)
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1
NTUH
Taipei, Taiwan