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| Name | Class |
|---|---|
| Peking University Aerospace Center Hospital | OTHER |
| General Hospital of Chinese Armed Police Forces | OTHER |
| Beijing Anzhen Hospital | OTHER |
| Beijing Biostats Technology Co. Ltd. |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics | Active Comparator | The patient take two chewing tablet per day, which contain 4.0E+10 CFU of probiotics. |
|
| Placebo | Placebo Comparator | The patient take two placebo chewing tablet per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| probiotics | Dietary Supplement | Daily take 4.0E+10 CFU of probiotics |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Microbiota-derived uremic toxin | follow up the patients at Month 0, 3, 6 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Fecal Microbiome | follow up the patients at Month 0, 3, 6 | 6 months |
| Changes in Fecal metabolites | follow up the patients at Month 0, 3, 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fazheng Ren, PhD | China Agricultural Universtiy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital | Beijing | 100029 | China | |||
| General Hospital of Chinese Armed Police Forces |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22992469 | Background | 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. | |
| 26400570 | Background | 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. |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| UNKNOWN |
| Beijing Heyiyuan Biotech Co. Ltd. | OTHER |
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| Placebo |
| Dietary Supplement |
|
| 6 months |
| Changes in Blood metabolites | follow up the patients at Month 0, 3, 6 | 6 months |
| Defecation questionnaire | follow up the patients at Month 0, 3, 6 | 6 months |
| Gastrointestinal Symptoms | follow up the patients at Month 0, 3, 6 | 6 months |
| The Kidney Disease Quality of Life | follow up the patients at Month 0, 3, 6 | 6 months |
| The Occurrence of Cardiovascular Event | 6 month follow-up |
| Beijing |
| 100039 |
| China |
| Peking University Aerospace Centre Hospital | Beijing | 100049 | China |
| 26376131 | Background | 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. |
| 23325079 | Background | 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. |
| 24231662 | Background | 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. |
| 27230658 | Background | 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. |
| 17898101 | Background | Meyer TW, Hostetter TH. Uremia. N Engl J Med. 2007 Sep 27;357(13):1316-25. doi: 10.1056/NEJMra071313. No abstract available. |
| 21784895 | Background | 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. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019602 |
| Food and Beverages |