Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT04608851
Status:
UNKNOWN
Last Update Posted:
2022-07-06
First Post:
2020-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preventing Urinary Tract Infections With E. Coli Nissle:
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014552', 'term': 'Urinary Tract Infections'}, {'id': 'D004927', 'term': 'Escherichia coli 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'}, {'id': 'D004756', 'term': 'Enterobacteriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The intervention drug or placebo will be given to participants in closed boxes without any labels. Appearance and dosing of the products will be similar. Investigators will not handle the boxes or study products.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double Blinded, Placebo controlled and randomized clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 530}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-05', 'studyFirstSubmitDate': '2020-10-28', 'studyFirstSubmitQcDate': '2020-10-28', 'lastUpdatePostDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence of urinary tract infections', 'timeFrame': 'Six months from study entry', 'description': 'Proportion of the study patient who will have at least one bacterial culture confirmed urinary tract infection'}], 'secondaryOutcomes': [{'measure': 'Number of urinary tract infections', 'timeFrame': 'Six months from study entry', 'description': 'Number of bacterial culture confirmed urinary tract infections per person years at risk (PYR)'}, {'measure': 'Hospitalization day due to bacterial culture confirmed urinary tract infection', 'timeFrame': 'Six months from study entry', 'description': 'Number of days spent in the hospital during follow up'}, {'measure': 'Antimicrobial treatment days for suspected or confirmed urinary tract infection', 'timeFrame': 'Six months, starting after the initial treatment at study entry has ended', 'description': 'Number of days when study patient has received antimicrobial treatment'}, {'measure': 'Stomach pain', 'timeFrame': 'Six months from study entry', 'description': 'Number of days with stomach pain reported by families during follow up at web-based surveys'}, {'measure': 'Diarrhea', 'timeFrame': 'Six months from study entry', 'description': 'Number of days with diarrhea reported by families during follow up at web-based survey'}, {'measure': 'Antimicrobial treatment days for any indication', 'timeFrame': 'Six months, starting after the initial treatment at study entry has ended', 'description': 'Number of days when study patient has received antimicrobial treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Urinary Tract Infections', 'E. coli'], 'conditions': ['Urinary Tract Infections in Children', 'Secondary Prevention']}, 'descriptionModule': {'briefSummary': 'Urinary tract infections (UTIs) account for 5-14% of pediatric emergency department visits annually. At the moment, up to one third of children suffering of acute (UTI) will have a new infection and there is a lack of effective methods for preventing secondary UTIs in young children. Majority of UTIs in children are caused by intestinal bacteria of the patient, mainly E. coli that colonizes gut of the patient. E. coli Nissle is a probiotic strain that has been used successfully for treating acute gastrointestinal infections in children. The strain has also been proved to be safe for infants and young children. E. coli Nissle could be a potential solution for preventing recurrent urinary tract infections in children as it competes with pathogenic bacteria that usually cause UTIs in children.\n\nThe aim of this study is to evaluate efficacy of E. coli Nissle strain in secondary prevention of urinary tract infections in young children.', 'detailedDescription': 'In order to asses efficacy of E. coli Nissle strain in prevention of recurrent UTIs in children, we aim to conduct randomized, placebo controlled and double blinded clinical trial. We are going to recruit children who are suffering the first urinary tract infection of their life. The UTI will be treated by normal clinical recommendations decided by treating physician. Intervention will start on the day following the last day of the antimicrobial course.\n\nThe intervention will last for 15 days and the study participants will receive either intervention drug or placebo. Intervention drug contains 10 E8 CFU/ml of E. coli Nissle strain and will be administered as dose of 1 ml of oral suspension once daily for children aged under one year and twice daily for children aged more than one year.\n\nThe study patients will be monitored by monthly electronic surveys for six months after the intervention in order to measure proportion of the children who will have a new UTI during the follow up. We are also going to record possible adverse effects in both study groups. Also use of antimicrobial medication due to any reason will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children who suffer of the first urinary tract infection of their life defined as pyuria, presence of symptoms (fever or focal symptom), no other explanation for infection, bacterial culture positive or culture result pending\n* Written informed consent\n\nExclusion Criteria:\n\n* Preterm birth, gestational age less than 35 weeks\n* Signs of life-threatening infection (such as meningitis)\n* Detected anomaly in urinary tract\n* Primary immunodeficiency\n* Detected anomaly of GE tract\n* Ongoing antimicrobial prophylaxis\n* Hospital-acquired infection'}, 'identificationModule': {'nctId': 'NCT04608851', 'acronym': 'FinNissle', 'briefTitle': 'Preventing Urinary Tract Infections With E. Coli Nissle:', 'organization': {'class': 'OTHER', 'fullName': 'University of Oulu'}, 'officialTitle': 'Preventing Urinary Tract Infections in Infants and Young Children With Probiotic E. Coli Nissle:', 'orgStudyIdInfo': {'id': 'OYS_Tapiainen_002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nissle group', 'description': 'Intervention will start on the day following the ending of the antimicrobial treatment of the UTI. Patients will receive 1 ml of oral suspension containing 10 E8 CFU/ml of E coli Nissle. Patients under one year of age will receive one daily dose and patients aged more than one year will receive a dose twice daily. Intervention will last for 30 days', 'interventionNames': ['Drug: E. coli Nissle']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Intervention will start on the day following the ending of the antimicrobial treatment of the UTI. Patients will receive 1 ml of oral syrup consisting of Saccharum 630 mg/g and Aqua purificata 370 mg/g. Patients under one year of age will receive one daily dose and patients aged more than one year will receive a dose twice daily. Intervention will last for 30 days', 'interventionNames': ['Other: Placebo control']}], 'interventions': [{'name': 'E. coli Nissle', 'type': 'DRUG', 'otherNames': ['Mutaflor'], 'description': '1 ml of oral suspension containing 10 E8 CFU /ml of E. coli Nissle strain', 'armGroupLabels': ['Nissle group']}, {'name': 'Placebo control', 'type': 'OTHER', 'description': '1 ml oral syrup consisting of Saccharum 630 mg/g and Aqua purificata 370 mg/g.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00290', 'city': 'Helsinki', 'status': 'NOT_YET_RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Harri Saxen, MD, PhD', 'role': 'CONTACT', 'email': 'harri.saxen@hus.fi'}, {'name': 'Tea Nieminen, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Helsinki University Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '70210', 'city': 'Kuopio', 'status': 'NOT_YET_RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Marjo Renko, MD, Phd', 'role': 'CONTACT', 'email': 'marjo.renko@uef.fi'}, {'name': 'Katri Backman, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Päivi Kallunki-Saesmaa, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Kuopio University Hospital', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'zip': '90014', 'city': 'Oulu', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Terhi Tapiainen, MD, PhD', 'role': 'CONTACT', 'email': 'terhi.tapiainen@oulu.fi', 'phone': '+358-8-315 5185'}, {'name': 'Niko Paalanne, MD, PhD', 'role': 'CONTACT', 'email': 'niko.paalanne@oulu.fi', 'phone': '+358-8-315-8427'}, {'name': 'Terhi Tapiainen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mikael Hakkola, BM', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Niko Paalanne, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kimmo Halt, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tytti Pokka, MSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ulla Koskela, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Pediatrics, Oulu University Hospital', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'zip': '33520', 'city': 'Tampere', 'status': 'NOT_YET_RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Merja Helminen, MD, PhD', 'role': 'CONTACT', 'email': 'merja.helminen@pshp.fi'}, {'name': 'Sari Törmänen, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'zip': '20521', 'city': 'Turku', 'status': 'NOT_YET_RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Ville Peltola, MD, PhD', 'role': 'CONTACT', 'email': 'ville.peltola@utu.fi'}, {'name': 'Lauri Ivaska, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'centralContacts': [{'name': 'Terhi Tapiainen', 'role': 'CONTACT', 'email': 'terhi.tapiainen@oulu.fi', 'phone': '+35883155185'}], 'overallOfficials': [{'name': 'Terhi Tapiainen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oulu'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will be shared after reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oulu', 'class': 'OTHER'}, 'collaborators': [{'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, {'name': 'Kuopio University Hospital', 'class': 'OTHER'}, {'name': 'Tampere University Hospital', 'class': 'OTHER'}, {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Adjunct Professor of Pediatrics', 'investigatorFullName': 'Terhi Tapiainen', 'investigatorAffiliation': 'University of Oulu'}}}}