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

China Agricultural University

Status and phase

Completed

Phase 3

Phase 2

Conditions

Kidney Failure, Chronic

Treatments

Dietary Supplement: probiotics

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03010735

CAUPCKD-02

Details and patient eligibility

About

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.

Enrollment

150 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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