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

Study Overview
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Brief Summary
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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.

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

Conditions
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Kidney Failure, Chronic

Intervention / Treatment
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* Other: No interventions, questionnaire, collect specimen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy subjects<br>Normal kidney function | Other: No interventions, questionnaire, collect specimen<br> <br> |
| ESRD patients<br>Diagnosed as ESRD with hemodialysis | Other: No interventions, questionnaire, collect specimen<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiota-derived uremic toxin |  | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uremic toxins, Kidney Failure, Chronic, Gastrointestinal Microbiome, Metabolomics