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)

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03010735

Enrollment

150

Registered

2017-01-05

Start date

2015-06-30

Completion date

2017-12-31

Last updated

2020-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Failure, Chronic

Keywords

Kidney Failure, Chronic, Probiotics, Uremic toxins, Gastrointestinal Microbiome

Brief 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.

Interventions

DIETARY_SUPPLEMENTprobiotics

Daily take 4.0E+10 CFU of probiotics

DIETARY_SUPPLEMENTPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026