The Correlation Between Gut Microbiome/Metabolite and End Stage Renal Disease (ESRD)
NCT ID: NCT03010696
Last Updated: 2020-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
293 participants
OBSERVATIONAL
2015-06-30
2017-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Multi-omics Analysis of Chronic Kidney Disease
NCT05543291
Alternations of Intestinal Microbiota and Health Impact in CKD
NCT03794401
Chinese Cohort Study of Chronic Kidney Disease
NCT03041987
CKD Cachexia and Gut Microbiome
NCT06986265
Intestinal Transport of Microbial Metabolites in Chronic Kidney Disease
NCT01752738
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Healthy subjects
Normal kidney function
No interventions, questionnaire, collect specimen
ESRD patients
Diagnosed as ESRD with hemodialysis
No interventions, questionnaire, collect specimen
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
No interventions, questionnaire, collect specimen
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Liver and kidney function is normal
* 18.5≤BMI≤29.9
* Agree to sign the informed consent form
* 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
Exclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Peking University Aerospace Center Hospital
OTHER
General Hospital of Chinese Armed Police Forces
OTHER
Beijing Anzhen Hospital
OTHER
Peking University Shougang Hospital
OTHER
Beijing Heyiyuan Biotech Co. Ltd.
OTHER
Shenzhen Microbiota Technology Co. Ltd.
UNKNOWN
China Agricultural University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Fazheng Ren
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Fazheng Ren, PhD
Role: PRINCIPAL_INVESTIGATOR
China Agricultural Universtiy
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beijing Anzhen Hospital
Beijing, , China
General Hospital of Chinese Armed Police Forces
Beijing, , China
Peking University Aerospace Centre Hospital
Beijing, , China
Peking University Shougang Hospital
Beijing, , China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
Meyer TW, Hostetter TH. Uremia. N Engl J Med. 2007 Sep 27;357(13):1316-25. doi: 10.1056/NEJMra071313. No abstract available.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CAUPCKD-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.