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

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ClinicalTrials.gov Identifier: NCT03010696
Recruitment Status : Unknown
Verified January 2017 by Fazheng Ren, China Agricultural University.
Recruitment status was:  Active, not recruiting
First Posted : January 5, 2017
Last Update Posted : January 5, 2017
Sponsor:
Collaborators:
Peking University Aerospace Centre Hospital
General Hospital of Chinese Armed Police Forces
Beijing Anzhen Hospital
Peking University Shougang Hospital
Beijing Heyiyuan Biotech Co. Ltd.
Shenzhen Microbiota Technology Co. Ltd.
Information provided by (Responsible Party):
Fazheng Ren, China Agricultural University

Tracking Information
First Submitted Date December 28, 2016
First Posted Date January 5, 2017
Last Update Posted Date January 5, 2017
Study Start Date June 2015
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 3, 2017)
Microbiota-derived uremic toxin [ Time Frame: Through study completion, an average of 1 year ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 3, 2017)
  • Fecal Microbiome [ Time Frame: Through study completion, an average of 1 year ]
  • Fecal metabolites [ Time Frame: Through study completion, an average of 1 year ]
  • Blood metabolites [ Time Frame: Through study completion, an average of 1 year ]
  • Complete blood count [ Time Frame: Through study completion, an average of 1 year ]
  • Blood biochemistry test [ Time Frame: Through study completion, an average of 1 year ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Correlation Between Gut Microbiome/Metabolite and End Stage Renal Disease (ESRD)
Official Title The Correlation Between Gut Microbiome/Metabolite and End Stage Renal Disease (ESRD)
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
whole blood, serum, feces, urine
Sampling Method Probability Sample
Study Population Two hundred and twenty three ESRD patients with hemodialysis are recruited from Department of Nephrology of 4 hospitals. Seventy healthy subjects are also recruited to compare the microbiome/metabolite differences between two groups.
Condition Kidney Failure, Chronic
Intervention Other: No interventions, questionnaire, collect specimen
Study Groups/Cohorts
  • Healthy subjects
    Normal kidney function
    Intervention: Other: No interventions, questionnaire, collect specimen
  • ESRD patients
    Diagnosed as ESRD with hemodialysis
    Intervention: Other: No interventions, questionnaire, collect specimen
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: January 3, 2017)
293
Original Actual Enrollment Same as current
Estimated Study Completion Date December 2017
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03010696
Other Study ID Numbers CAUPCKD-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Fazheng Ren, China Agricultural University
Study Sponsor China Agricultural University
Collaborators
  • Peking University Aerospace Centre Hospital
  • General Hospital of Chinese Armed Police Forces
  • Beijing Anzhen Hospital
  • Peking University Shougang Hospital
  • Beijing Heyiyuan Biotech Co. Ltd.
  • Shenzhen Microbiota Technology Co. Ltd.
Investigators
Principal Investigator: Fazheng Ren, PhD China Agricultural Universtiy
PRS Account China Agricultural University
Verification Date January 2017