Effects of Probiotics on the Patients With 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 effects of oral administration of probiotics on the metabolism of uremic toxins, in the patients with End Stage Renal Disease (ESRD). One hundred and fifty hemodialysis patients are recruited, and a Double Blind Randomized Parallel Controlled Trial was performed.The microbiota-derived uremic toxin, such as indoxyl sulfate and p-cresol sulfate, are measured as Primary Outcome. The Fecal microbiome, fecal metabolites, blood metabolites, defecation, Gastrointestinal Symptoms The Kidney Disease Quality of Life and The Occurrence of Cardiovascular Event are also assessed.

Official Title
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Effects of Probiotics on Metabolism of Uremic Toxin in Patients With End Stage Renal Disease (ESRD)

Conditions
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Kidney Failure, Chronic

Intervention / Treatment
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* Dietary Supplement: probiotics
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18 years old Patients who diagnosed as ESRD with hemodialysis Fixed hemodialysis cycle (average 3 times a week) Agree to take the products to be studied during the study period, and no longer take other fermented dairy products (live lactic acid bacteria drinks, cheese, yogurt, probiotic products, etc.) Agree to sign the informed consent form Exclusion Criteria: Taking antibiotics or antifungal drugs within 30 days before the study Have serious allergic reaction to skim milk powder Researcher 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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotics<br>The patient take two chewing tablet per day, which contain 4.0E+10 CFU of probiotics. | Dietary Supplement: probiotics<br>* Daily take 4.0E+10 CFU of probiotics<br>|
| Placebo Comparator: Placebo<br>The patient take two placebo chewing tablet per day. | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Microbiota-derived uremic toxin | follow up the patients at Month 0, 3, 6 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Fecal Microbiome | follow up the patients at Month 0, 3, 6 | 6 months | 
| Changes in Fecal metabolites | follow up the patients at Month 0, 3, 6 | 6 months | 
| Changes in Blood metabolites | follow up the patients at Month 0, 3, 6 | 6 months | 
| Defecation questionnaire | follow up the patients at Month 0, 3, 6 | 6 months | 
| Gastrointestinal Symptoms | follow up the patients at Month 0, 3, 6 | 6 months | 
| The Kidney Disease Quality of Life | follow up the patients at Month 0, 3, 6 | 6 months | 
| The Occurrence of Cardiovascular Event |  | 6 month follow-up | 

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