NCT03010696

Brief Summary

The purpose of this study is to investigate the differences of gut Microbiome/Metabolite between ESRD patients and healthy subjects. Two hundred and twenty three hemodialysis patients and 70 healthy subjects are recruited, and a cross-sectional study is performed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
293

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Typical duration for all trials

Geographic Reach
1 country

4 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
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
6 months 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
11 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

1.1 years

First QC Date

December 28, 2016

Last Update Submit

October 21, 2020

Conditions

Kidney Failure, Chronic

Keywords

Kidney Failure, ChronicUremic toxinsGastrointestinal MicrobiomeMetabolomics

Outcome Measures

Primary Outcomes (1)

  • Microbiota-derived uremic toxin

    Through study completion, an average of 1 year

Secondary Outcomes (5)

  • Fecal Microbiome

    Through study completion, an average of 1 year

  • Fecal metabolites

    Through study completion, an average of 1 year

  • Blood metabolites

    Through study completion, an average of 1 year

  • Complete blood count

    Through study completion, an average of 1 year

  • Blood biochemistry test

    Through study completion, an average of 1 year

Study Arms (2)

Healthy subjects

Normal kidney function

Other: No interventions, questionnaire, collect specimen

ESRD patients

Diagnosed as ESRD with hemodialysis

Other: No interventions, questionnaire, collect specimen

Interventions

No interventions, questionnaire, collect specimenOTHER
ESRD patientsHealthy subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Two hundred and twenty three ESRD patients with hemodialysis are recruited from Department of Nephrology of 4 hospitals. Seventy healthy subjects are also recruited to compare the microbiome/metabolite differences between two groups.

You may qualify if:

  • Age over 18 years old
  • Liver and kidney function is normal
  • ≤BMI≤29.9
  • Agree to sign the informed consent form

You may not qualify if:

  • Diagnosed as Metabolic syndrome
  • Diagnosed as Cirrhosis
  • Diagnosed as kidney disease
  • Taking fermented food (live lactic acid bacteria drinks, cheese, yogurt, probiotic products, etc.) within 14 days before the study
  • Taking antibiotics or antifungal drugs within 30 days before the study
  • For ESRD patients
  • Age over 18 years old
  • Patients who diagnosed as ESRD with hemodialysis
  • Fixed hemodialysis cycle (average 3 times a week)
  • Agree to sign the informed consent form
  • Taking antibiotics or antifungal drugs within 30 days before the study
  • Taking fermented food (live lactic acid bacteria drinks, cheese, yogurt, probiotic products, etc.) within 14 days before the study
  • Reasercher 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 (4)

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

Peking University Shougang Hospital

Beijing, 100144, China

Location

Related Publications (9)

  • 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

  • Wang X, Yang S, Li S, Zhao L, Hao Y, Qin J, Zhang L, Zhang C, Bian W, Zuo L, Gao X, Zhu B, Lei XG, Gu Z, Cui W, Xu X, Li Z, Zhu B, Li Y, Chen S, Guo H, Zhang H, Sun J, Zhang M, Hui Y, Zhang X, Liu X, Sun B, Wang L, Qiu Q, Zhang Y, Li X, Liu W, Xue R, Wu H, Shao D, Li J, Zhou Y, Li S, Yang R, Pedersen OB, Yu Z, Ehrlich SD, Ren F. Aberrant gut microbiota alters host metabolome and impacts renal failure in humans and rodents. Gut. 2020 Dec;69(12):2131-2142. doi: 10.1136/gutjnl-2019-319766. Epub 2020 Apr 2.

    PMID: 32241904DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, feces, urine

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Surveys and Questionnaires

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)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Fazheng Ren, PhD

    China Agricultural Universtiy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
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

July 1, 2016

Study Completion

December 1, 2017

Last Updated

October 22, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(4)