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Alternations of Intestinal Microbiota and Health Impact in CKD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03794401
Recruitment Status : Recruiting
First Posted : January 7, 2019
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
Szu-Chun Hung, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Study Description
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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.

Condition or disease
Chronic Kidney Disease

Study Design
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Study Type : Observational
Estimated Enrollment : 750 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Alternations of Intestinal Microbiota and Health Impact in Chronic Kidney Disease (AIM-HI CKD): A Cohort Study
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. renal outcome [ Time Frame: 3-year follow-up ]
    a composite of ≥40% decrease in eGFR and ESRD needing chronic dialysis or preemptive kidney transplantation

  2. 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 Outcome Measures :
  1. all-cause mortality [ Time Frame: 3-year follow-up ]
    CV death or non-CV death

  2. 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


Other Outcome Measures:
  1. 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


Biospecimen Retention:   Samples With DNA
whole blood, serum, white cells, urine, feces

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Regional Hospital
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03794401


Contacts
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Contact: TING-YUN LIN +886-2-66289779 ext 2350 water_h2o_6@hotmail.com

Locations
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Taiwan
Taipei Tzu Chi Hospital Recruiting
New Taipei City, Taiwan
Contact: Szu-Chun Hung, MD         
Sponsors and Collaborators
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Investigators
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Principal Investigator: SZU-CHUNG HUNG Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
More Information
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Responsible Party: Szu-Chun Hung, Attending physician, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
ClinicalTrials.gov Identifier: NCT03794401    
Other Study ID Numbers: 07-XD-074
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Szu-Chun Hung, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation:
body composition
chronic kidney disease
dietary pattern
gut microbiot
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency