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The Correlation Between Gut Microbiome/Metabolite and End Stage Renal Disease (ESRD)

C

China Agricultural University

Status

Completed

Conditions

Kidney Failure, Chronic

Treatments

Other: No interventions, questionnaire, collect specimen

Study type

Observational

Funder types

Other

Identifiers

NCT03010696
CAUPCKD-01

Details and patient eligibility

About

The purpose of this study is to investigate the differences of gut Microbiome/Metabolite between ESRD patients and healthy subjects. Two hundred and twenty three hemodialysis patients and 70 healthy subjects are recruited, and a cross-sectional study is performed.

Enrollment

293 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

For Healthy Subjects

Inclusion Criteria:

  • Age over 18 years old
  • Liver and kidney function is normal
  • 18.5≤BMI≤29.9
  • Agree to sign the informed consent form

Exclusion Criteria:

  • Diagnosed as Metabolic syndrome
  • Diagnosed as Cirrhosis
  • Diagnosed as kidney disease
  • Taking fermented food (live lactic acid bacteria drinks, cheese, yogurt, probiotic products, etc.) within 14 days before the study
  • Taking antibiotics or antifungal drugs within 30 days before the study

For ESRD patients

Inclusion criteria:

  • Age over 18 years old
  • Patients who diagnosed as ESRD with hemodialysis
  • Fixed hemodialysis cycle (average 3 times a week)
  • Agree to sign the informed consent form

Exclusion criteria:

  • Taking antibiotics or antifungal drugs within 30 days before the study
  • Taking fermented food (live lactic acid bacteria drinks, cheese, yogurt, probiotic products, etc.) within 14 days before the study
  • Reasercher are not sure whether the subjects are willing or able to complete the study
  • Subject participated in other research projects within two months before the study

Trial design

293 participants in 2 patient groups

Healthy subjects
Description:
Normal kidney function
Treatment:
Other: No interventions, questionnaire, collect specimen
ESRD patients
Description:
Diagnosed as ESRD with hemodialysis
Treatment:
Other: No interventions, questionnaire, collect specimen

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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