The Correlation Between Gut Microbiome/Metabolite and End Stage Renal Disease (ESRD)

Kidney Failure, Chronic Clinical Trial

Official title:

The Correlation Between Gut Microbiome/Metabolite and End Stage Renal Disease (ESRD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03010696
• Other study ID #: CAUPCKD-01
• Status: Completed
• 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: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 293
• Est. completion date: December 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

For Healthy Subjects

Inclusion Criteria:

• Age over 18 years old

• Liver and kidney function is normal

• 18.5=BMI=29.9

• Agree to sign the informed consent form

Exclusion Criteria:

• 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

Inclusion criteria:

• 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:

• 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

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Other:
• No interventions, questionnaire, collect specimen

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
China	Peking University Shougang Hospital	Beijing

Sponsors (7)

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

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	Microbiota-derived uremic toxin		Through study completion, an average of 1 year
Secondary	Fecal Microbiome		Through study completion, an average of 1 year
Secondary	Fecal metabolites		Through study completion, an average of 1 year
Secondary	Blood metabolites		Through study completion, an average of 1 year
Secondary	Complete blood count		Through study completion, an average of 1 year
Secondary	Blood biochemistry test		Through study completion, an average of 1 year