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

NCT03010735 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2020-10-22

No results posted yet for this study

Summary

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.

Conditions

  • Kidney Failure, Chronic

Interventions

DIETARY_SUPPLEMENT

probiotics

Daily take 4.0E+10 CFU of probiotics

DIETARY_SUPPLEMENT

Placebo

Sponsors & Collaborators

  • Peking University Aerospace Center Hospital

    collaborator OTHER

  • General Hospital of Chinese Armed Police Forces

    collaborator OTHER

  • Beijing Anzhen Hospital

    collaborator OTHER

  • Beijing Biostats Technology Co. Ltd.

    collaborator UNKNOWN

  • Beijing Heyiyuan Biotech Co. Ltd.

    collaborator OTHER

  • China Agricultural University

    lead OTHER

Principal Investigators

  • Fazheng Ren, PhD · China Agricultural Universtiy

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2017-02-28
Completion
2017-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03010735 on ClinicalTrials.gov