NCT03010735

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 5, 2017

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

1.7 years

First QC Date

December 28, 2016

Last Update Submit

October 20, 2020

Conditions

Kidney Failure, Chronic

Keywords

Kidney Failure, ChronicProbioticsUremic toxinsGastrointestinal Microbiome

Outcome Measures

Primary Outcomes (1)

  • Changes in Microbiota-derived uremic toxin

    follow up the patients at Month 0, 3, 6

    6 months

Secondary Outcomes (7)

  • Changes in Fecal Microbiome

    6 months

  • Changes in Fecal metabolites

    6 months

  • Changes in Blood metabolites

    6 months

  • Defecation questionnaire

    6 months

  • Gastrointestinal Symptoms

    6 months

  • +2 more secondary outcomes

Study Arms (2)

Probiotics

ACTIVE COMPARATOR

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

Dietary Supplement: probiotics

Placebo

PLACEBO COMPARATOR

The patient take two placebo chewing tablet per day.

Dietary Supplement: Placebo

Interventions

probioticsDIETARY_SUPPLEMENT

Daily take 4.0E+10 CFU of probiotics

Probiotics
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Beijing Anzhen Hospital

Beijing, 100029, China

Location

General Hospital of Chinese Armed Police Forces

Beijing, 100039, China

Location

Peking University Aerospace Centre Hospital

Beijing, 100049, China

Location

Related Publications (8)

  • 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.

    PMID: 22992469BACKGROUND

  • 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.

    PMID: 26400570BACKGROUND

  • 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.

    PMID: 26376131BACKGROUND

  • 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.

    PMID: 23325079BACKGROUND

  • 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.

    PMID: 24231662BACKGROUND

  • 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.

    PMID: 27230658BACKGROUND

  • Meyer TW, Hostetter TH. Uremia. N Engl J Med. 2007 Sep 27;357(13):1316-25. doi: 10.1056/NEJMra071313. No abstract available.

    PMID: 17898101BACKGROUND

  • 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.

    PMID: 21784895BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Fazheng Ren, PhD

    China Agricultural Universtiy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 28, 2016

First Posted

January 5, 2017

Study Start

June 1, 2015

Primary Completion

February 1, 2017

Study Completion

December 1, 2017

Last Updated

October 22, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)