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
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

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