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

Completed

• Conditions: Kidney Failure, Chronic
• Interventions: Other: No interventions, questionnaire, collect specimen

• Registration Number: NCT03010696
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Primary Completion: 2016-07
• Study First Submitted: 2016-12-28
• Study First Submitted QC: 2017-01-03
• Study First Posted: 2017-01-05
• Study Completion: 2017-12
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-21
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 293

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ESRD patients	No interventions, questionnaire, collect specimen	Diagnosed as ESRD with hemodialysis
Healthy subjects	No interventions, questionnaire, collect specimen	Normal kidney function

Primary Outcome Measures

Name	Time	Method
Microbiota-derived uremic toxin	Through study completion, an average of 1 year

Secondary Outcome Measures

Name	Time	Method
Fecal Microbiome	Through study completion, an average of 1 year
Complete blood count	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
Blood biochemistry test	Through study completion, an average of 1 year

Trial Locations

Locations (4)

Peking University Aerospace Centre Hospital; 🇨🇳 Beijing, China

Beijing Anzhen Hospital; 🇨🇳 Beijing, China

General Hospital of Chinese Armed Police Forces; 🇨🇳 Beijing, China

Peking University Shougang Hospital; 🇨🇳 Beijing, China