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

Sponsor

China Agricultural University (Other)

Overall Status

Completed

CT.gov ID

NCT03010696

Collaborator

Peking University Aerospace Centre Hospital (Other), General Hospital of Chinese Armed Police Forces (Other), Beijing Anzhen Hospital (Other), Peking University Shougang Hospital (Other), Beijing Heyiyuan Biotech Co. Ltd. (Other), Shenzhen Microbiota Technology Co. Ltd. (Other)

293

Enrollment

Locations

Duration (Months)

73.3

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Kidney Failure, Chronic	Other: No interventions, questionnaire, collect specimen

Study Design

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 :

Jun 1, 2015

Actual Primary Completion Date :

Jul 1, 2016

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Microbiota-derived uremic toxin [Through study completion, an average of 1 year]

Secondary Outcome Measures

Fecal Microbiome [Through study completion, an average of 1 year]
Fecal metabolites [Through study completion, an average of 1 year]
Blood metabolites [Through study completion, an average of 1 year]
Complete blood count [Through study completion, an average of 1 year]
Blood biochemistry test [Through study completion, an average of 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Beijing Anzhen Hospital	Beijing	China	100029
2	General Hospital of Chinese Armed Police Forces	Beijing	China	100039
3	Peking University Aerospace Centre Hospital	Beijing	China	100049
4	Peking University Shougang Hospital	Beijing	China	100144