Trial | NCT03010735  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    150
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 Started
Jun 30
2015
Primary Completion
Feb 28
2017
Study Completion
Dec 31
2017
Last Update
Oct 22
2020

Dietary Supplement probiotics

Daily take 4.0E+10 CFU of probiotics

Dietary Supplement Placebo

Probiotics Active Comparator

The patient take two chewing tablet per day, which contain 4.0E+10 CFU of probiotics.

Placebo Placebo Comparator

The patient take two placebo chewing tablet per day.

Criteria 

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
No Results Posted