NCT03794401UnknownNot Applicable
Alternations of Intestinal Microbiota and Health Impact in Chronic Kidney Disease (AIM-HI CKD): A Cohort Study
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation1 site in 1 country750 target enrollmentStarted: April 1, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 750
- Locations
- 1
- Primary Endpoint
- renal outcome
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
renal outcome
Time Frame: 3-year follow-up
a composite of ≥40% decrease in eGFR and ESRD needing chronic dialysis or preemptive kidney transplantation
cardiovascular outcome
Time Frame: 3-year follow-up
a composite of major adverse CV events, defined as CV death, myocardial infarction, or ischemic stroke
Secondary Outcomes
- all-cause mortality(3-year follow-up)
- neurological outcome(3-year follow-up)
Investigators
Szu-Chun Hung
Attending physician
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Study Sites (1)
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