Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-28 @ 6:56 PM
Study NCT ID:
NCT05359094
Status:
COMPLETED
Last Update Posted:
2024-07-23
First Post:
2022-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Probiotic Supplements in Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-19', 'studyFirstSubmitDate': '2022-04-27', 'studyFirstSubmitQcDate': '2022-04-27', 'lastUpdatePostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimated glomerular filtration rate (eGFR) measurement', 'timeFrame': 'Baseline to 24 week', 'description': 'The eGFR level is a maker for kidney function'}, {'measure': 'Blood Urea Nitrogen (BUN) levels', 'timeFrame': 'Baseline to 24 week', 'description': 'Blood Urea Nitrogen'}, {'measure': 'Electrolytes Analysis', 'timeFrame': 'Baseline to 24 week', 'description': "The concentration of electrolytes analysis in the subject's blood samples"}], 'secondaryOutcomes': [{'measure': 'Uremic toxins assay', 'timeFrame': 'Baseline to 24 week', 'description': "The concentration of p-cresol sulfate level, indoxyl sulfates level, and trimethylamine N-oxide level (TMAO) in the subjects' blood samples"}, {'measure': 'Sugar test', 'timeFrame': 'Baseline to 24 week', 'description': "The concentration of fasting sugar and HbA1C in the subjects' blood samples"}, {'measure': 'Nutrition status', 'timeFrame': 'Baseline to 24 week', 'description': "The concentration of albumin,TIBC,TFS and uric acid in the subjects' blood samples"}, {'measure': 'Inflammation makers', 'timeFrame': 'Baseline to 24 week', 'description': "The concentration of inflammation makers in the subjects' blood samples"}, {'measure': 'Liver function', 'timeFrame': 'Baseline to 24 week', 'description': "The concentration of ALT and AST in the subjects' blood samples"}, {'measure': 'Lipid analysis', 'timeFrame': 'Baseline to 24 week', 'description': "The concentration of total cholesterol , triglyceride , HDL-cholesterol and LDL-cholesterol in the subjects' blood samples"}, {'measure': 'The quality of life', 'timeFrame': 'Baseline to 24 week', 'description': 'Health-related quality of life was measured by 5-level EQ-5D questionnaire'}, {'measure': 'Complete Blood Count (CBC) Test', 'timeFrame': 'Baseline to 24 week', 'description': "The concentration of CBC test in the subject's blood samples"}, {'measure': 'Urine Analysis', 'timeFrame': 'Baseline to 24 week', 'description': 'Urine specimen collection will be evaluate such as urine routine ,bacteria, protein and MCP-1.'}, {'measure': '24-hour Dietary recall', 'timeFrame': 'Baseline to 24 week', 'description': 'There will be collected by food models or a photography atlas to estimate portion size.'}, {'measure': 'Safety and compliance', 'timeFrame': 'Baseline to 24 week', 'description': 'Gastrointestinal symptoms measured by questionnaire'}, {'measure': 'Grip strength levels', 'timeFrame': 'Baseline to 24 week', 'description': 'Hand grip strength was measured by grip strength device'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Probiotics', 'Chronic kidney disease'], 'conditions': ['Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'This research will investigate the effect of oral probiotic supplements on renal function, uremic toxins inflammatory response, nutrition status, gastrointestinal symptoms, and QoL with Chronic kidney disease.', 'detailedDescription': 'Chronic kidney disease (CKD) with gut microbiota was different from a normal person. Some gut microbiota produces short-chain fatty acids or induces functional enzymes beneficial to patients. On the other hand, some gut microbiota may also metabolize amino acids into p-cresol and indole which were leading to the accumulation of urinary toxins and damage to the kidney. This research will investigate the effect of oral probiotic supplements on renal function, uremic toxins, inflammatory response, nutrition status, gastrointestinal symptoms, and QoL with CKD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Aged over 20 years old.\n2. Patients with 2\\~3a stage chronic kidney disease.\n3. Those who can cooperate with the research plan for 3 visits and retain samples (blood, urine).\n\nExclusion criteria::\n\n1. Use of other probiotics during the study.\n2. Those with active infectious diseases in the past month.\n3. Those who have used antibiotics within the past 1 month or during the study.\n4. Women who are pregnant or breastfeeding.\n5. Obstructive nephropathy within the past month.\n6. Polycystic kidney disease (polycystic kidney disease).\n7. Acute kidney disease within the past 3 months.\n8. Gastrointestinal bleeding within the past 3 months.\n9. Malignancy.\n10. Severe cardiovascular disease (cardiovascular disease) in the past 3 months, such as coronary artery disease (coronary artery disease), myocardial ischemia (myocardial ischemia), NYHA class IV myocardial failure, cerebrovascular disease, or peripheral artery disease.'}, 'identificationModule': {'nctId': 'NCT05359094', 'briefTitle': 'Probiotic Supplements in Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Taichung Veterans General Hospital'}, 'officialTitle': 'To Explore the Effect of Probiotic Supplements in Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'SF22054A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Probiotics', 'description': 'Probiotics', 'interventionNames': ['Dietary Supplement: Probiotics']}], 'interventions': [{'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo (Microcrystalline α-cellulose) supplement with a Plant-Dominant Low-Protein Diet', 'armGroupLabels': ['Placebo']}, {'name': 'Probiotics', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Probiotics(Pediococcus acidilactici GKA4) supplement with a Plant-Dominant Low-Protein Diet', 'armGroupLabels': ['Probiotics']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40705', 'city': 'Taichung', 'state': 'ROC', 'country': 'Taiwan', 'facility': 'Taiwan', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'overallOfficials': [{'name': 'Cheng-Hsu Chen, MDPHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Nephrology in Taichung Veterans General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taichung Veterans General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Grape King Bio Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}