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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03010696

Enrollment

293

Registered

2017-01-05

Start date

2015-06-30

Completion date

2017-12-31

Last updated

2020-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Failure, Chronic

Keywords

Kidney Failure, Chronic, Uremic toxins, Gastrointestinal Microbiome, Metabolomics

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.

Interventions

OTHERNo interventions, questionnaire, collect specimen

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Microbiota-derived uremic toxin	Through study completion, an average of 1 year

Secondary

Measure	Time frame
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026