Alternations of Intestinal Microbiota and Health Impact in CKD

February 28, 2022 updated by: Szu-Chun Hung, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

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

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • New Taipei City, Taiwan
        • Recruiting
        • Taipei Tzu Chi Hospital
        • Contact:
          • Szu-Chun Hung, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Regional Hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
renal outcome
Time Frame: 3-year follow-up
a composite of ≥40% decrease in eGFR and ESRD needing chronic dialysis or preemptive kidney transplantation
3-year follow-up
cardiovascular outcome
Time Frame: 3-year follow-up
a composite of major adverse CV events, defined as CV death, myocardial infarction, or ischemic stroke
3-year follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all-cause mortality
Time Frame: 3-year follow-up
CV death or non-CV death
3-year follow-up
neurological outcome
Time Frame: 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
3-year follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of lean body mass, measured by bioimpedance spectroscopy every 3 months for 2 years
Time Frame: 2-year
the change of lean body mass
2-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Investigators

  • Principal Investigator: SZU-CHUNG HUNG, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2019

Primary Completion (ANTICIPATED)

June 30, 2023

Study Completion (ANTICIPATED)

June 30, 2023

Study Registration Dates

First Submitted

January 1, 2019

First Submitted That Met QC Criteria

January 4, 2019

First Posted (ACTUAL)

January 7, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 28, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-XD-074

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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