Effects of Probiotics on the Patients With End Stage Renal Disease (ESRD)

October 20, 2020 updated by: Fazheng Ren, China Agricultural University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100029
        • Beijing Anzhen Hospital
      • Beijing, China, 100039
        • General Hospital of Chinese Armed Police Forces
      • Beijing, China, 100049
        • Peking University Aerospace Centre Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Agricultural University

Collaborators

General Hospital of Chinese Armed Police Forces
Beijing Anzhen Hospital
Peking University Aerospace Centre Hospital
Beijing Biostats Technology Co. Ltd.
Beijing Heyiyuan Biotech Co. Ltd.

Investigators

  • Principal Investigator: Fazheng Ren, PhD, China Agricultural Universtiy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

December 28, 2016

First Submitted That Met QC Criteria

January 4, 2017

First Posted (Estimate)

January 5, 2017

Study Record Updates

Last Update Posted (Actual)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 20, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAUPCKD-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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