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Alternations of Intestinal Microbiota and Health Impact in CKD

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03794401
Enrollment
750
Registered
2019-01-07
Start date
2019-04-01
Completion date
2023-06-30
Last updated
2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

Keywords

body composition, chronic kidney disease, dietary pattern, gut microbiot

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.

Interventions

None listed

Sponsors

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
renal outcome3-year follow-upa composite of ≥40% decrease in eGFR and ESRD needing chronic dialysis or preemptive kidney transplantation
cardiovascular outcome3-year follow-upa composite of major adverse CV events, defined as CV death, myocardial infarction, or ischemic stroke

Secondary

MeasureTime frameDescription
all-cause mortality3-year follow-upCV death or non-CV death
neurological outcome3-year follow-upthe change of cognitive function or they development of dementia assessed by the Modified Mini-Mental Status Exam annually for 3 years

Other

MeasureTime frameDescription
change of lean body mass, measured by bioimpedance spectroscopy every 3 months for 2 years2-yearthe change of lean body mass

Countries

Taiwan

Contacts

Primary ContactTING-YUN LIN
water_h2o_6@hotmail.com+886-2-66289779

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026