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

Kidney Failure, Chronic Clinical Trial

Official title:

Effects of Probiotics on Metabolism of Uremic Toxin in Patients With End Stage Renal Disease (ESRD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03010735
• Other study ID #: CAUPCKD-02
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 2015
• Est. completion date: December 2017

Study information

• Verified date: October 2020
• Source: China Agricultural University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Dietary Supplement:
• probiotics
Daily take 4.0E+10 CFU of probiotics
• Placebo

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing
China	General Hospital of Chinese Armed Police Forces	Beijing
China	Peking University Aerospace Centre Hospital	Beijing

Sponsors (6)

Lead Sponsor	Collaborator
China Agricultural University	Beijing Anzhen Hospital, Beijing Biostats Technology Co. Ltd., Beijing Heyiyuan Biotech Co. Ltd., General Hospital of Chinese Armed Police Forces, Peking University Aerospace Centre Hospital

Country where clinical trial is conducted

China, 

References & Publications (8)

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. Review. — View 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. — View 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. Review. — View Citation

Meyer TW, Hostetter TH. Uremia. N Engl J Med. 2007 Sep 27;357(13):1316-25. Review. — View 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. Epub 2016 May 26. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Microbiota-derived uremic toxin	follow up the patients at Month 0, 3, 6	6 months
Secondary	Changes in Fecal Microbiome	follow up the patients at Month 0, 3, 6	6 months
Secondary	Changes in Fecal metabolites	follow up the patients at Month 0, 3, 6	6 months
Secondary	Changes in Blood metabolites	follow up the patients at Month 0, 3, 6	6 months
Secondary	Defecation questionnaire	follow up the patients at Month 0, 3, 6	6 months
Secondary	Gastrointestinal Symptoms	follow up the patients at Month 0, 3, 6	6 months
Secondary	The Kidney Disease Quality of Life	follow up the patients at Month 0, 3, 6	6 months
Secondary	The Occurrence of Cardiovascular Event		6 month follow-up