Clinical trial NCT03010735: Effects of Probiotics on the Patients With End Stage Renal Disease (ESRD)
Official title: Effects of Probiotics on Metabolism of Uremic Toxin in Patients With End Stage Renal Disease (ESRD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Kidney Failure, Chronic
Keywords: Kidney Failure, Chronic
Probiotics
Uremic toxins
Gastrointestinal Microbiome
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: Beijing Biostats Technology Co. Ltd.
name: Beijing Heyiyuan Biotech Co. Ltd.
First posted: 2017-01-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in Microbiota-derived uremic toxin
timeFrame: 6 months
Secondary outcomes:
measure: Changes in Fecal Microbiome
timeFrame: 6 months
measure: Changes in Fecal metabolites
timeFrame: 6 months
measure: Changes in Blood metabolites
timeFrame: 6 months
measure: Defecation questionnaire
timeFrame: 6 months
measure: Gastrointestinal Symptoms
timeFrame: 6 months
measure: The Kidney Disease Quality of Life
timeFrame: 6 months
measure: The Occurrence of Cardiovascular Event
timeFrame: 6 month follow-up
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
Study officials:
affiliation: China Agricultural Universtiy
name: Fazheng Ren, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
citation: 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.
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.
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.