Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 6:20 PM
Study NCT ID:
NCT03462160
Status:
UNKNOWN
Last Update Posted:
2018-03-12
First Post:
2018-02-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Probiotics Prophylaxis of Urinary Tract Infections in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 106}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-09', 'studyFirstSubmitDate': '2018-02-28', 'studyFirstSubmitQcDate': '2018-03-09', 'lastUpdatePostDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'frequencies of recurrence of UTI', 'timeFrame': '6 months after intervention', 'description': 'New onset of symptomatic UTI within the 6 months follow-up period.'}], 'secondaryOutcomes': [{'measure': 'frequencies of hospitalization due to UTI', 'timeFrame': '6 months after intervention'}, {'measure': 'the number of days of antibiotic therapy due to UTI', 'timeFrame': '6 months after intervention'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Urinary Tract Infection', 'prophylaxis', 'probiotics'], 'conditions': ['Prevention of Urinary Tract Infections in Children']}, 'referencesModule': {'references': [{'pmid': '26140267', 'type': 'RESULT', 'citation': 'Tewary K, Narchi H. Recurrent urinary tract infections in children: Preventive interventions other than prophylactic antibiotics. World J Methodol. 2015 Jun 26;5(2):13-9. doi: 10.5662/wjm.v5.i2.13. eCollection 2015 Jun 26.'}, {'pmid': '26695595', 'type': 'RESULT', 'citation': 'Schwenger EM, Tejani AM, Loewen PS. Probiotics for preventing urinary tract infections in adults and children. Cochrane Database Syst Rev. 2015 Dec 23;2015(12):CD008772. doi: 10.1002/14651858.CD008772.pub2.'}, {'pmid': '29102297', 'type': 'RESULT', 'citation': 'Hosseini M, Yousefifard M, Ataei N, Oraii A, Mirzay Razaz J, Izadi A. The efficacy of probiotics in prevention of urinary tract infection in children: A systematic review and meta-analysis. J Pediatr Urol. 2017 Dec;13(6):581-591. doi: 10.1016/j.jpurol.2017.08.018. Epub 2017 Oct 9.'}, {'pmid': '33097017', 'type': 'DERIVED', 'citation': 'Daniel M, Szymanik-Grzelak H, Turczyn A, Panczyk-Tomaszewska M. Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1 versus placebo as a prophylaxis for recurrence urinary tract infections in children: a study protocol for a randomised controlled trial. BMC Urol. 2020 Oct 23;20(1):168. doi: 10.1186/s12894-020-00723-1.'}]}, 'descriptionModule': {'briefSummary': 'The investigators aim to assess the effectiveness of prophylaxis of urinary tract infections in children with a probiotic containing Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1. It is formulated a hypothesis that a 3-months course of probiotic prophylasis is more effective than placebo.', 'detailedDescription': 'In previously published European and global guidelines, there has been no consensus among experts regarding the prophylaxis of recurrence urinary tract infections. Depending on the recommendation, the prevention of recurrence UTI should be used, not justified, or should be used in special cases. However, preparations that will be effective in preventing UTI and will not cause bacterial resistance are still sought.\n\n106 patients aged 3 to 18 years with recurrence UTIs (defined as: ≥2 infections in the upper urinary tract or 1 UTI in the upper urinary tract and ≥1 in the lower urinary tract or ≥3 or more UTI in the lower urinary tract in one year) or children with ≥1 infection in the upper urinary tract and ≥1 of recurrent UTIs risk factors (congenital anomalies of the kidney and urinary tract, constipation, bladder dysfunction, myelomeningocele, sexual activity in girls) will be randomly assigned to receive a 90-days prophylaxsis arm (probiotic UroLact containing Lactobacillus Rhamnosus PL1 and Lactobacillus Plantarum PM1) or a 90-days placebo arms.\n\nThe primary outcome measure will be frequencies of recurrence of UTI during the 6 months after the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* recurrent UTIs (defined as: ≥2 infections in the upper urinary tract or 1 UTI in the upper urinary tract and ≥1 in the lower urinary tract or ≥3 or more UTI in the lower urinary tract in one year) OR 1 infection in the upper urinary tract and ≥1 of recurrent UTIs risk factors: congenital anomalies of the kidney and urinary tract, constipation, bladder dysfunction, myelomeningocele, sexual activity in girls\n* ≥1 episode of urinary tract infection in the last 6 months\n\nExclusion Criteria:\n\n* intake of probiotic preparations for ≥1 month in the last 3 months\n* known allergy to the study products\n* immunosuppression therapy\n* disease with immune deficiency\n* children with other coexisting infection, e.g. meningitis, sepsis, pneumonia, otitis'}, 'identificationModule': {'nctId': 'NCT03462160', 'briefTitle': 'Effectiveness of Probiotics Prophylaxis of Urinary Tract Infections in Children', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': 'Effectiveness of Prophylaxis of Urinary Tract Infections in Children With a Probiotic Containing Lactobacillus Rhamnosus PL1 and Lactobacillus Plantarum PM1, a Randomised Clinical Trial', 'orgStudyIdInfo': {'id': 'UTI probiotic'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo supply for 90 days', 'description': 'Patients will receive placebo (in blinded sachets)', 'interventionNames': ['Other: Placebo control group']}, {'type': 'EXPERIMENTAL', 'label': 'Probiotic supply for 90 days', 'description': 'Patients will receive probiotics containing Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1 (in blinded sachets).', 'interventionNames': ['Dietary Supplement: Probiotic experimental group']}], 'interventions': [{'name': 'Placebo control group', 'type': 'OTHER', 'description': 'Placebo will be administered orally, after dissolving the sachet in lukewarm water, every evening during the meal. The placebo appearance will be similar to the probiotic.', 'armGroupLabels': ['Placebo supply for 90 days']}, {'name': 'Probiotic experimental group', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Probiotic UroLact containing Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1 will be administered orally, after dissolving the sachet in lukewarm water, every evening during the meal.', 'armGroupLabels': ['Probiotic supply for 90 days']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02-091', 'city': 'Warsaw', 'country': 'Poland', 'facility': "Children's Hospital for The Medical University of Warsaw", 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Maria Daniel, MD', 'role': 'CONTACT', 'email': 'maria.daniel@wum.edu.pl', 'phone': '696477117', 'phoneExt': '0048'}, {'name': 'Hanna Szymanik-Grzelak, PhD', 'role': 'CONTACT', 'email': 'h.szymanik@interia.pl', 'phone': '223179656', 'phoneExt': '0048'}], 'overallOfficials': [{'name': 'Malgorzata Panczyk-Tomaszewska, Assistant Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical University of Warsaw'}, {'name': 'Maria Daniel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Warsaw'}, {'name': 'Hanna Szymanik-Grzelak, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Warsaw'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'collaborators': [{'name': 'Miralex Sp. z o.o.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}