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

Primary Purpose

Kidney Failure, Chronic

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
probiotics
Placebo
Sponsored by
China Agricultural University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Failure, Chronic focused on measuring Kidney Failure, Chronic, Probiotics, Uremic toxins, Gastrointestinal Microbiome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Beijing Anzhen Hospital
  • General Hospital of Chinese Armed Police Forces
  • Peking University Aerospace Centre Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Probiotics

Placebo

Arm Description

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

The patient take two placebo chewing tablet per day.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in Fecal Microbiome
follow up the patients at Month 0, 3, 6
Changes in Fecal metabolites
follow up the patients at Month 0, 3, 6
Changes in Blood metabolites
follow up the patients at Month 0, 3, 6
Defecation questionnaire
follow up the patients at Month 0, 3, 6
Gastrointestinal Symptoms
follow up the patients at Month 0, 3, 6
The Kidney Disease Quality of Life
follow up the patients at Month 0, 3, 6
The Occurrence of Cardiovascular Event

Full Information

First Posted
December 28, 2016
Last Updated
October 20, 2020
Sponsor
China Agricultural University
Collaborators
Peking University Aerospace Centre Hospital, General Hospital of Chinese Armed Police Forces, Beijing Anzhen Hospital, Beijing Biostats Technology Co. Ltd., Beijing Heyiyuan Biotech Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03010735
Brief Title
Effects of Probiotics on the Patients With End Stage Renal Disease (ESRD)
Official Title
Effects of Probiotics on Metabolism of Uremic Toxin in Patients With End Stage Renal Disease (ESRD)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Agricultural University
Collaborators
Peking University Aerospace Centre Hospital, General Hospital of Chinese Armed Police Forces, Beijing Anzhen Hospital, Beijing Biostats Technology Co. Ltd., Beijing Heyiyuan Biotech Co. Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic
Keywords
Kidney Failure, Chronic, Probiotics, Uremic toxins, Gastrointestinal Microbiome

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotics
Arm Type
Active Comparator
Arm Description
The patient take two chewing tablet per day, which contain 4.0E+10 CFU of probiotics.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The patient take two placebo chewing tablet per day.
Intervention Type
Dietary Supplement
Intervention Name(s)
probiotics
Intervention Description
Daily take 4.0E+10 CFU of probiotics
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Changes in Microbiota-derived uremic toxin
Description
follow up the patients at Month 0, 3, 6
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Changes in Fecal Microbiome
Description
follow up the patients at Month 0, 3, 6
Time Frame
6 months
Title
Changes in Fecal metabolites
Description
follow up the patients at Month 0, 3, 6
Time Frame
6 months
Title
Changes in Blood metabolites
Description
follow up the patients at Month 0, 3, 6
Time Frame
6 months
Title
Defecation questionnaire
Description
follow up the patients at Month 0, 3, 6
Time Frame
6 months
Title
Gastrointestinal Symptoms
Description
follow up the patients at Month 0, 3, 6
Time Frame
6 months
Title
The Kidney Disease Quality of Life
Description
follow up the patients at Month 0, 3, 6
Time Frame
6 months
Title
The Occurrence of Cardiovascular Event
Time Frame
6 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fazheng Ren, PhD
Organizational Affiliation
China Agricultural Universtiy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Anzhen Hospital
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
General Hospital of Chinese Armed Police Forces
City
Beijing
ZIP/Postal Code
100039
Country
China
Facility Name
Peking University Aerospace Centre Hospital
City
Beijing
ZIP/Postal Code
100049
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22992469
Citation
Vaziri ND, Wong J, Pahl M, Piceno YM, Yuan J, DeSantis TZ, Ni Z, Nguyen TH, Andersen GL. Chronic kidney disease alters intestinal microbial flora. Kidney Int. 2013 Feb;83(2):308-15. doi: 10.1038/ki.2012.345. Epub 2012 Sep 19.
Results Reference
background
PubMed Identifier
26400570
Citation
Poesen R, Windey K, Neven E, Kuypers D, De Preter V, Augustijns P, D'Haese P, Evenepoel P, Verbeke K, Meijers B. The Influence of CKD on Colonic Microbial Metabolism. J Am Soc Nephrol. 2016 May;27(5):1389-99. doi: 10.1681/ASN.2015030279. Epub 2015 Sep 23.
Results Reference
background
PubMed Identifier
26376131
Citation
Koppe L, Mafra D, Fouque D. Probiotics and chronic kidney disease. Kidney Int. 2015 Nov;88(5):958-66. doi: 10.1038/ki.2015.255. Epub 2015 Sep 16.
Results Reference
background
PubMed Identifier
23325079
Citation
Anders HJ, Andersen K, Stecher B. The intestinal microbiota, a leaky gut, and abnormal immunity in kidney disease. Kidney Int. 2013 Jun;83(6):1010-6. doi: 10.1038/ki.2012.440. Epub 2013 Jan 16.
Results Reference
background
PubMed Identifier
24231662
Citation
Ramezani A, Raj DS. The gut microbiome, kidney disease, and targeted interventions. J Am Soc Nephrol. 2014 Apr;25(4):657-70. doi: 10.1681/ASN.2013080905. Epub 2013 Nov 14.
Results Reference
background
PubMed Identifier
27230658
Citation
Poesen R, Claes K, Evenepoel P, de Loor H, Augustijns P, Kuypers D, Meijers B. Microbiota-Derived Phenylacetylglutamine Associates with Overall Mortality and Cardiovascular Disease in Patients with CKD. J Am Soc Nephrol. 2016 Nov;27(11):3479-3487. doi: 10.1681/ASN.2015121302. Epub 2016 May 26.
Results Reference
background
PubMed Identifier
17898101
Citation
Meyer TW, Hostetter TH. Uremia. N Engl J Med. 2007 Sep 27;357(13):1316-25. doi: 10.1056/NEJMra071313. No abstract available.
Results Reference
background
PubMed Identifier
21784895
Citation
Aronov PA, Luo FJ, Plummer NS, Quan Z, Holmes S, Hostetter TH, Meyer TW. Colonic contribution to uremic solutes. J Am Soc Nephrol. 2011 Sep;22(9):1769-76. doi: 10.1681/ASN.2010121220. Epub 2011 Jul 22.
Results Reference
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Effects of Probiotics on the Patients With End Stage Renal Disease (ESRD)

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