Alternations of Intestinal Microbiota and Health Impact in CKD
- Conditions
- Chronic Kidney Disease
- Registration Number
- NCT03794401
- Brief Summary
This study is aimed to evaluate the impact of dietary pattern, gut microbiota and their interactions on clinical outcomes among patient with CKD stage 3-5.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 750
Inclusion Criteria
- Patients with CKD stage 3-5 defined as eGFR <60 ml/min/1.73 m2 calculated with the use of the four-variable Modification of Diet in Renal Disease formula who have not yet on dialysis therapy.
Exclusion Criteria
- Patients with active cancer
- Patients with liver cirrhosis
- Patients have taken antibiotics within three months before screening for inclusion.
- Patients with a cardiac pacemaker or metallic implants,
- Patients are amputees
- Pregnant women
- Patients with inherited renal diseases
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method renal outcome 3-year follow-up a composite of ≥40% decrease in eGFR and ESRD needing chronic dialysis or preemptive kidney transplantation
cardiovascular outcome 3-year follow-up a composite of major adverse CV events, defined as CV death, myocardial infarction, or ischemic stroke
- Secondary Outcome Measures
Name Time Method all-cause mortality 3-year follow-up CV death or non-CV death
neurological outcome 3-year follow-up the change of cognitive function or they development of dementia assessed by the Modified Mini-Mental Status Exam annually for 3 years
Trial Locations
- Locations (1)
Taipei Tzu Chi Hospital
🇨🇳New Taipei City, Taiwan