Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT04204005
Status:
COMPLETED
Last Update Posted:
2022-07-05
First Post:
2019-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Probiotics and Low Protein Diet in Advanced 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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single-centre, double-blind, placebo-controlled, randomised study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-01', 'studyFirstSubmitDate': '2019-11-29', 'studyFirstSubmitQcDate': '2019-12-16', 'lastUpdatePostDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline of the microbial gut populations', 'timeFrame': '5 months', 'description': '* Change from baseline of the concentration of proteolytic microbial groups (number of cells/gram of faeces);\n* Change from baseline of the concentration of saccharolytic microbial groups (number of cells/gram of faeces)'}, {'measure': 'Change from baseline of the microbial inflammatory uremic toxins', 'timeFrame': '5 months', 'description': 'Change from baseline of the serum concentration of PC (mcMOL) and IS (mcMOL), as markers of dysbiotic microbiota'}, {'measure': 'Change from baseline of the markers of cardiovascular diseases', 'timeFrame': '5 months', 'description': 'Change from baseline of the serum concentration of Lp-PLA2 (nmol/ml/min)'}, {'measure': 'Change from baseline of the markers of intestinal barrier permeability', 'timeFrame': '5 months', 'description': 'Change from baseline of the serum concentration of LPS (EU/ml)'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the renal function', 'timeFrame': '5 months', 'description': 'Change from baseline of ΔGFR (mL/min/m2 of body surface)'}, {'measure': 'Measurement of the urine protein excretion', 'timeFrame': '5 months', 'description': 'Change from baseline of 24-hour protein urine excretion (mg/24 hours)'}, {'measure': 'Evaluation of the anemia', 'timeFrame': '5 months', 'description': 'Change from baseline of haemoglobin (g/dL)'}, {'measure': 'Evaluation of the serum acid-base equilibrium', 'timeFrame': '5 months', 'description': 'Change from baseline of bicarbonatemia (mEq/l)'}, {'measure': 'Quantification of serum inflammatory markers', 'timeFrame': '5 months', 'description': 'Change from baseline of the serum concentration of C-reactive protein (CRP) (mg/dL)'}, {'measure': 'Evaluation of the body composition', 'timeFrame': '5 months', 'description': 'Change from baseline of fat-free body mass (kg), fat-body mass (kg), Hand Grip strength (kg), total body water (kg)'}, {'measure': 'Measurement of vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health (Quality of Life)', 'timeFrame': '5 months', 'description': 'Change from baseline of SF36 questionnaire score. The SF36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Low protein diet', 'Chronic kidney disease', 'Gut microbiota', 'Microbial uremic toxins', 'Probiotic bacteria', 'Intestinal dysbiosis'], 'conditions': ['Renal Failure Chronic']}, 'referencesModule': {'references': [{'pmid': '26338727', 'type': 'BACKGROUND', 'citation': 'Marchesi JR, Adams DH, Fava F, Hermes GD, Hirschfield GM, Hold G, Quraishi MN, Kinross J, Smidt H, Tuohy KM, Thomas LV, Zoetendal EG, Hart A. The gut microbiota and host health: a new clinical frontier. Gut. 2016 Feb;65(2):330-9. doi: 10.1136/gutjnl-2015-309990. Epub 2015 Sep 2.'}, {'pmid': '26590448', 'type': 'BACKGROUND', 'citation': 'Ramezani A, Massy ZA, Meijers B, Evenepoel P, Vanholder R, Raj DS. Role of the Gut Microbiome in Uremia: A Potential Therapeutic Target. Am J Kidney Dis. 2016 Mar;67(3):483-98. doi: 10.1053/j.ajkd.2015.09.027. Epub 2015 Nov 15.'}, {'pmid': '26034597', 'type': 'BACKGROUND', 'citation': 'Mafra D, Fouque D. Gut microbiota and inflammation in chronic kidney disease patients. Clin Kidney J. 2015 Jun;8(3):332-4. doi: 10.1093/ckj/sfv026. Epub 2015 May 6.'}, {'pmid': '24762311', 'type': 'BACKGROUND', 'citation': 'Mafra D, Lobo JC, Barros AF, Koppe L, Vaziri ND, Fouque D. Role of altered intestinal microbiota in systemic inflammation and cardiovascular disease in chronic kidney disease. Future Microbiol. 2014;9(3):399-410. doi: 10.2217/fmb.13.165.'}, {'pmid': '23316359', 'type': 'BACKGROUND', 'citation': 'Rossi M, Klein K, Johnson DW, Campbell KL. Pre-, pro-, and synbiotics: do they have a role in reducing uremic toxins? A systematic review and meta-analysis. Int J Nephrol. 2012;2012:673631. doi: 10.1155/2012/673631. Epub 2012 Dec 19.'}, {'pmid': '26772192', 'type': 'BACKGROUND', 'citation': 'Vaziri ND. Effect of Synbiotic Therapy on Gut-Derived Uremic Toxins and the Intestinal Microbiome in Patients with CKD. Clin J Am Soc Nephrol. 2016 Feb 5;11(2):199-201. doi: 10.2215/CJN.13631215. Epub 2016 Jan 15. No abstract available.'}, {'pmid': '37870148', 'type': 'DERIVED', 'citation': 'Cooper TE, Khalid R, Chan S, Craig JC, Hawley CM, Howell M, Johnson DW, Jaure A, Teixeira-Pinto A, Wong G. Synbiotics, prebiotics and probiotics for people with chronic kidney disease. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD013631. doi: 10.1002/14651858.CD013631.pub2.'}]}, 'descriptionModule': {'briefSummary': 'Here the investigators will perform a double-blinded randomized placebo-controlled clinical trial to evaluate the synergic effect of low protein diet and prebiotics in reducing the microbial inflammatory uremic toxins.', 'detailedDescription': 'ProLowCKD is a single-centre, double-blind, placebo-controlled, randomised study. At enrolment (T0) participants were prescribed a LPD in addition to their ongoing pharmacological therapy and according to their comorbidities; after 2 months (T2) they were randomized in accordance to a 1:1 ratio to receive probiotics or placebo for other 3 months (T5) in addition to the continuation of LPD. Enrolled subjects are invited to assume two doses of probiotic/placebo for 1 month and 1 dose for 2 months.\n\nRandomization is 1:1 to receive odd- or even envelopes, according to the odd- or even registration number at enrolment.\n\nNeither the clinician nor the patient knows the content of the odd- and even envelopes.\n\nThe evaluations will be performed according to the following schedule: at T0 nephrological evaluation and biochemical analysis, dietary counselling, illustration of protocol and signing of the informed consent, administration of the SF36 questionnaire, body composition evaluation by bioimpedentiometry. At T0, T2, T5: blood biochemical parameters: haemoglobin, urea, creatinine, mean urea and creatinine clearance, CKD and MDRD calculation, sodium, potassium, uric acid, calcium, phosphate, PTH, acid-base balance, CRP, albumin, PC, IS, Lp-PLA2, LPS; 24h-urine biochemical parameters: urea, creatinine, sodium, proteins; microbial stools analysis; clinical nephrological and dietitian evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-80 years\n* GFR \\< 20 ml/min/sqm\n* afferent to the outpatient clinic in the Nephrology and Dialysis Unit (Azienda Ospedaliero Universitaria Maggiore della Carità)\n\nDrop out or Exclusion Criteria:\n\n* subject refusing to sign the informed consent\n* administration of prolonged antibacterial therapy\n* dialysis initiation\n* death'}, 'identificationModule': {'nctId': 'NCT04204005', 'acronym': 'ProLowCKD', 'briefTitle': 'Probiotics and Low Protein Diet in Advanced Chronic Kidney Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Probiotical S.p.A.'}, 'officialTitle': 'Probiotics-addicted Low-protein Diet for Microbiota Modulation in Patients With Advanced Chronic Kidney Disease (ProLowCKD): a Protocol of Placebo-controlled Randomized Trial', 'orgStudyIdInfo': {'id': '215/CE n.CE 30\\17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Probiotics', 'description': 'Composition: 5x109 of Bifidobacterium longum (mix DLBL), 1x109 Lactobacillus reuteri LRE02 (DSM 23878) and maltodextrin (total 2 grams)', 'interventionNames': ['Dietary Supplement: Probiotics']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Composition: maltodextrin (2 grams)', 'interventionNames': ['Dietary Supplement: Probiotics']}], 'interventions': [{'name': 'Probiotics', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Active composition: 5x109 of Bifidobacterium longum (mix DLBL), 1x 109 Lactobacillus reuteri LRE02 (DSM 23878) and maltodextrin (total 2 grams). The probiotic species employed were granted the Qualified Presumption of Safety (QPS) status by the European Food Safety Authority (EFSA) in 2007. Two envelopes per day and one envelope per day will be recommended for one and two months, respectively.\n\nPlacebo composition: maltodextrin (2 grams). Two envelopes per day and one envelope per day will be recommended for one and two months, respectively.', 'armGroupLabels': ['Placebo', 'Probiotics']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28100', 'city': 'Novara', 'country': 'Italy', 'facility': 'Nephrology and Dialysis Unit, Azienda Ospedaliero Universitaria Maggiore della Carità', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}], 'overallOfficials': [{'name': 'Andreana De Mauri', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda Ospedaliero Universitaria Maggiore della Carità'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Probiotical S.p.A.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Azienda Ospedaliero Universitaria Maggiore della Carita', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}