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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 : 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

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.

Condition or disease Intervention/treatment
Kidney Failure, Chronic Other: No interventions, questionnaire, collect specimen

Study Type : Observational
Actual Enrollment : 293 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: The Correlation Between Gut Microbiome/Metabolite and End Stage Renal Disease (ESRD)
Study Start Date : June 2015
Actual Primary Completion Date : July 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Failure

Group/Cohort Intervention/treatment
Healthy subjects
Normal kidney function
Other: No interventions, questionnaire, collect specimen
ESRD patients
Diagnosed as ESRD with hemodialysis
Other: No interventions, questionnaire, collect specimen



Primary Outcome Measures :
  1. Microbiota-derived uremic toxin [ Time Frame: Through study completion, an average of 1 year ]

Secondary Outcome Measures :
  1. Fecal Microbiome [ Time Frame: Through study completion, an average of 1 year ]
  2. Fecal metabolites [ Time Frame: Through study completion, an average of 1 year ]
  3. Blood metabolites [ Time Frame: Through study completion, an average of 1 year ]
  4. Complete blood count [ Time Frame: Through study completion, an average of 1 year ]
  5. Blood biochemistry test [ Time Frame: Through study completion, an average of 1 year ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

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): NCT03010696


Locations
China
Beijing Anzhen Hospital
Beijing, China, 100029
General Hospital of Chinese Armed Police Forces
Beijing, China, 100039
Peking University Aerospace Centre Hospital
Beijing, China, 100049
Peking University Shougang Hospital
Beijing, China, 100144
Sponsors and Collaborators
China Agricultural University
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

Publications:

Responsible Party: Fazheng Ren, Professor, China Agricultural University
ClinicalTrials.gov Identifier: NCT03010696     History of Changes
Other Study ID Numbers: CAUPCKD-01
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: January 5, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Fazheng Ren, China Agricultural University:
Kidney Failure, Chronic
Uremic toxins
Gastrointestinal Microbiome
Metabolomics

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic