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NCT03794401 Clinical Trial

Alternations of Intestinal Microbiota and Health Impact in CKD

Chronic Kidney Disease Clinical Trial

Official title:
Alternations of Intestinal Microbiota and Health Impact in Chronic Kidney Disease (AIM-HI CKD): A Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03794401
Other study ID # 07-XD-074
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2019
Est. completion date June 30, 2023

Study information
Verified date February 2022
Source Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Contact TING-YUN LIN
Phone +886-2-66289779
Email water_h2o_6@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 750
Est. completion date June 30, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers
Gender All
Age group 20 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Taiwan Taipei Tzu Chi Hospital New Taipei City

Sponsors (1)
Lead Sponsor Collaborator
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Other change of lean body mass, measured by bioimpedance spectroscopy every 3 months for 2 years the change of lean body mass 2-year
Primary renal outcome a composite of =40% decrease in eGFR and ESRD needing chronic dialysis or preemptive kidney transplantation 3-year follow-up
Primary cardiovascular outcome a composite of major adverse CV events, defined as CV death, myocardial infarction, or ischemic stroke 3-year follow-up
Secondary all-cause mortality CV death or non-CV death 3-year follow-up
Secondary neurological outcome the change of cognitive function or they development of dementia assessed by the Modified Mini-Mental Status Exam annually for 3 years 3-year follow-up
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