Kidney Failure, Chronic Clinical Trial
Official title:
The Correlation Between Gut Microbiome/Metabolite and End Stage Renal Disease (ESRD)
NCT number | NCT03010696 |
Other study ID # | CAUPCKD-01 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 2015 |
Est. completion date | December 2017 |
Verified date | October 2020 |
Source | China Agricultural University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
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. |
China,
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
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 |
Status | Clinical Trial | Phase | |
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