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

Sponsor

China Agricultural University (Other)

Overall Status

Completed

CT.gov ID

NCT03010735

Collaborator

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

150

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Failure, Chronic	Dietary Supplement: probiotics Dietary Supplement: Placebo	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jun 1, 2015

Actual Primary Completion Date :

Feb 1, 2017

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Changes in Microbiota-derived uremic toxin [6 months]
follow up the patients at Month 0, 3, 6

Secondary Outcome Measures

Changes in Fecal Microbiome [6 months]
follow up the patients at Month 0, 3, 6
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
Gastrointestinal Symptoms [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Beijing Anzhen Hospital	Beijing	China	100029
2	General Hospital of Chinese Armed Police Forces	Beijing	China	100039
3	Peking University Aerospace Centre Hospital	Beijing	China	100049