Effects of Probiotics on the Patients With End Stage Renal Disease (ESRD)
NCT ID: NCT03010735
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
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COMPLETED
PHASE2/PHASE3
150 participants
INTERVENTIONAL
2015-06-30
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Probiotics
The patient take two chewing tablet per day, which contain 4.0E+10 CFU of probiotics.
probiotics
Daily take 4.0E+10 CFU of probiotics
Placebo
The patient take two placebo chewing tablet per day.
Placebo
Interventions
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probiotics
Daily take 4.0E+10 CFU of probiotics
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Peking University Aerospace Center Hospital
OTHER
General Hospital of Chinese Armed Police Forces
OTHER
Beijing Anzhen Hospital
OTHER
Beijing Biostats Technology Co. Ltd.
UNKNOWN
Beijing Heyiyuan Biotech Co. Ltd.
OTHER
China Agricultural University
OTHER
Responsible Party
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Fazheng Ren
Professor
Principal Investigators
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Fazheng Ren, PhD
Role: PRINCIPAL_INVESTIGATOR
China Agricultural Universtiy
Locations
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Beijing Anzhen Hospital
Beijing, , China
General Hospital of Chinese Armed Police Forces
Beijing, , China
Peking University Aerospace Centre Hospital
Beijing, , China
Countries
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References
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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.
Other Identifiers
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CAUPCKD-02
Identifier Type: -
Identifier Source: org_study_id
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