Clinical trial NCT03010696: The Correlation Between Gut Microbiome/Metabolite and End Stage Renal Disease (ESRD)
Official title: The Correlation Between Gut Microbiome/Metabolite and End Stage Renal Disease (ESRD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Failure, Chronic
Keywords: Kidney Failure, Chronic
Uremic toxins
Gastrointestinal Microbiome
Metabolomics
Lead sponsor: China Agricultural University
Sponsor class: OTHER
Collaborators: name: Peking University Aerospace Center Hospital
name: General Hospital of Chinese Armed Police Forces
name: Beijing Anzhen Hospital
name: Peking University Shougang Hospital
name: Beijing Heyiyuan Biotech Co. Ltd.
name: Shenzhen Microbiota Technology Co. Ltd.
First posted: 2017-01-05
Enrollment: 293
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Two hundred and twenty three ESRD patients with hemodialysis are recruited from Department of Nephrology of 4 hospitals. Seventy healthy subjects are also recruited to compare the microbiome/metabolite differences between two groups.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Microbiota-derived uremic toxin
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Fecal Microbiome
timeFrame: Through study completion, an average of 1 year
measure: Fecal metabolites
timeFrame: Through study completion, an average of 1 year
measure: Blood metabolites
timeFrame: Through study completion, an average of 1 year
measure: Complete blood count
timeFrame: Through study completion, an average of 1 year
measure: Blood biochemistry test
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
city: Beijing
country: China
facility: General Hospital of Chinese Armed Police Forces
city: Beijing
country: China
facility: Peking University Aerospace Centre Hospital
city: Beijing
country: China
facility: Peking University Shougang Hospital
Study officials:
affiliation: China Agricultural Universtiy
name: Fazheng Ren, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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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. doi: 10.1681/ASN.2015121302. Epub 2016 May 26.
citation: Meyer TW, Hostetter TH. Uremia. N Engl J Med. 2007 Sep 27;357(13):1316-25. doi: 10.1056/NEJMra071313. No abstract available.
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.
citation: 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.