Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2026-06-16 @ 6:32 PM
Study NCT ID:
NCT03010735
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2016-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Probiotics on the Patients With End Stage Renal Disease (ESRD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-20', 'studyFirstSubmitDate': '2016-12-28', 'studyFirstSubmitQcDate': '2017-01-04', 'lastUpdatePostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Microbiota-derived uremic toxin', 'timeFrame': '6 months', 'description': 'follow up the patients at Month 0, 3, 6'}], 'secondaryOutcomes': [{'measure': 'Changes in Fecal Microbiome', 'timeFrame': '6 months', 'description': 'follow up the patients at Month 0, 3, 6'}, {'measure': 'Changes in Fecal metabolites', 'timeFrame': '6 months', 'description': 'follow up the patients at Month 0, 3, 6'}, {'measure': 'Changes in Blood metabolites', 'timeFrame': '6 months', 'description': 'follow up the patients at Month 0, 3, 6'}, {'measure': 'Defecation questionnaire', 'timeFrame': '6 months', 'description': 'follow up the patients at Month 0, 3, 6'}, {'measure': 'Gastrointestinal Symptoms', 'timeFrame': '6 months', 'description': 'follow up the patients at Month 0, 3, 6'}, {'measure': 'The Kidney Disease Quality of Life', 'timeFrame': '6 months', 'description': 'follow up the patients at Month 0, 3, 6'}, {'measure': 'The Occurrence of Cardiovascular Event', 'timeFrame': '6 month follow-up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Kidney Failure, Chronic', 'Probiotics', 'Uremic toxins', 'Gastrointestinal Microbiome'], 'conditions': ['Kidney Failure, Chronic']}, 'referencesModule': {'references': [{'pmid': '22992469', 'type': 'BACKGROUND', '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.'}, {'pmid': '26400570', 'type': 'BACKGROUND', '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."}, {'pmid': '26376131', 'type': 'BACKGROUND', '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.'}, {'pmid': '23325079', 'type': 'BACKGROUND', '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.'}, {'pmid': '24231662', 'type': 'BACKGROUND', '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.'}, {'pmid': '27230658', 'type': 'BACKGROUND', '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.'}, {'pmid': '17898101', 'type': 'BACKGROUND', 'citation': 'Meyer TW, Hostetter TH. Uremia. N Engl J Med. 2007 Sep 27;357(13):1316-25. doi: 10.1056/NEJMra071313. No abstract available.'}, {'pmid': '21784895', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18 years old\n* Patients who diagnosed as ESRD with hemodialysis\n* Fixed hemodialysis cycle (average 3 times a week)\n* 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.)\n* Agree to sign the informed consent form\n\nExclusion Criteria:\n\n* Taking antibiotics or antifungal drugs within 30 days before the study\n* Have serious allergic reaction to skim milk powder\n* Researcher are not sure whether the subjects are willing or able to complete the study\n* Subject participated in other research projects within two months before the study'}, 'identificationModule': {'nctId': 'NCT03010735', 'briefTitle': 'Effects of Probiotics on the Patients With End Stage Renal Disease (ESRD)', 'organization': {'class': 'OTHER', 'fullName': 'China Agricultural University'}, 'officialTitle': 'Effects of Probiotics on Metabolism of Uremic Toxin in Patients With End Stage Renal Disease (ESRD)', 'orgStudyIdInfo': {'id': 'CAUPCKD-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Probiotics', 'description': 'The patient take two chewing tablet per day, which contain 4.0E+10 CFU of probiotics.', 'interventionNames': ['Dietary Supplement: probiotics']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The patient take two placebo chewing tablet per day.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'probiotics', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Daily take 4.0E+10 CFU of probiotics', 'armGroupLabels': ['Probiotics']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Anzhen Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100039', 'city': 'Beijing', 'country': 'China', 'facility': 'General Hospital of Chinese Armed Police Forces', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100049', 'city': 'Beijing', 'country': 'China', 'facility': 'Peking University Aerospace Centre Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Fazheng Ren, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China Agricultural Universtiy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Agricultural University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking University Aerospace Center Hospital', 'class': 'OTHER'}, {'name': 'General Hospital of Chinese Armed Police Forces', 'class': 'OTHER'}, {'name': 'Beijing Anzhen Hospital', 'class': 'OTHER'}, {'name': 'Beijing Biostats Technology Co. Ltd.', 'class': 'UNKNOWN'}, {'name': 'Beijing Heyiyuan Biotech Co. Ltd.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Fazheng Ren', 'investigatorAffiliation': 'China Agricultural University'}}}}