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

Completed

• Conditions: Kidney Failure, Chronic

• 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

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)

Beijing Anzhen Hospital; 🇨🇳 Beijing, China

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

Peking University Aerospace Centre Hospital; 🇨🇳 Beijing, China

Peking University Shougang Hospital; 🇨🇳 Beijing, China