Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2025-12-25 @ 5:20 PM
Study NCT ID:
NCT04846803
Status:
RECRUITING
Last Update Posted:
2025-09-18
First Post:
2021-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bacterial Interference for Preventing Recurrent Urinary Tract Infection - New Ways of Treatment
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Inclusion with 6 months observation (standard treatment). Randomisation in ratio 3:1 for treatment initiation at baseline.\n\n1. Patients with prophylactic bladder flushing with an ABU strain.\n2. The control group with saline bladder flushing .'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-14', 'studyFirstSubmitDate': '2021-04-12', 'studyFirstSubmitQcDate': '2021-04-12', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of UTI events in the follow-up period', 'timeFrame': '1½ year', 'description': 'The number of prescriptions or hospital visits'}], 'secondaryOutcomes': [{'measure': 'Time to first UTI after the intervention', 'timeFrame': '1½ year', 'description': 'Symptoms and the need for medical treatment or hospitalisation'}, {'measure': 'Quality of life by standard Questionnaires_ICIQ-OABqol 08/04', 'timeFrame': '1½ year', 'description': 'International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life Module (ICIQ-OABqol).\n\nICIQ-OABqol is a patient-completed questionnaire evaluating the quality of life (QoL) in patients with overactive bladder. It is translated into Danish and chosen because UTI symptoms often resemble OAB symptoms.\n\nScoring: 25-160 overall score with greater values indicating increased impact on quality of life'}, {'measure': 'O´Leary-Sant Voiding and Pain symptom score', 'timeFrame': '1½ year', 'description': "The O'Leary-Sant Interstitial Cystitis Symptom Index is translated into Danish and chosen because UTI symptoms often resemble the bladder pain symptoms. The O'Leary-Sant instrument is comprised of a Symptom Index (score range: 0-20 points) and a Problem Index (score range: 0-16 points), each of which contains four questions related to urinary and pain symptoms. For each index, the score is calculated by summing the points for each item. Overall score with greater values indicating increased symptom severity."}, {'measure': 'EQ-5D-5L', 'timeFrame': '1½ year', 'description': "Questionnaire evaluating quality of life at 5 terms (mobility, self-care, usual activities, pain, discomfort and anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state. EQ-5D-5L health states may be converted into a single index value. The index values, presented in country-specific value sets, are a major feature of the EQ-5D instrument, facilitating the calculation of quality-adjusted life years (QALYs) that are used to inform economic evaluations of health care interventions."}, {'measure': 'CRF', 'timeFrame': '1½ year', 'description': 'Case report form with respect to urinary/bladder symptoms, odour, perfomancestatus ect'}, {'measure': 'Hospitalization', 'timeFrame': '1½ year', 'description': 'Hospital visit due to UTI'}, {'measure': 'Complications (bleeding, pain)', 'timeFrame': '1½ year', 'description': 'Complications due to bladder lavage'}, {'measure': 'Microbiological diagnostics: Etiology, resistance', 'timeFrame': '1½ year', 'description': 'Measurements during treatment protocol'}, {'measure': 'Creatinin', 'timeFrame': '1½ year', 'description': 'Measurements during treatment protocol in micromol/L'}, {'measure': 'Leukocytes and neutrofilocytes', 'timeFrame': '1½ year', 'description': 'Measurements during treatment protocol in 10E9/L'}, {'measure': 'Natrium and kalium', 'timeFrame': '1½ year', 'description': 'Measurements during treatment protocol in mmol/L'}, {'measure': 'CRP', 'timeFrame': '1½ year', 'description': 'Measurements during treatment protocol in mg/L'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rUTI', 'E.coli', 'prophylactic', 'bladder lavage'], 'conditions': ['Recurrent Urinary Tract Infections']}, 'descriptionModule': {'briefSummary': 'Urinary tract infection (UTI) is one of the most common bacterial infections worldwide. It affects 150 million people annually. Treatment of patients with UTI entails a high consumption of antibiotics and large social and health costs. With this protocol, we want to elucidate alternative treatment methods for especially recurrent urinary tract infection. Bacteria have internal competitiveness (bacterial interference) and it is known that the non-pathogenic E.coli can outcompete the pathogenic E.coli in laboratory studies.\n\nWe intend to strengthen the clinical evidence that it can be used as patient treatment through a clinical, placebo-controlled, double-blind trial at Odense University Hospital.', 'detailedDescription': 'Urinary tract infection (UTI) is one of the most common bacterial infections worldwide. It affects 150 million people annually. Treatment of patients with UTI entails a high consumption of antibiotics and large social and health costs. With this protocol, we want to elucidate alternative treatment methods for especially recurrent urinary tract infection. Bacteria have internal competitiveness (bacterial interference) and it is known that the non-pathogenic E.coli can outcompete the pathogenic E.coli in laboratory studies.\n\nWe intend to strengthen the clinical evidence that it can be used as patient treatment through a clinical, placebo-controlled, double-blind trial at Odense University Hospital.\n\nClaim to be investigated:\n\n* The non-pathogenic bacterial strain (ABU) E.coli can overcome the most common pathogenic E.coli (UPEC) in humans.\n* ABU can be used for preventive treatment in patients with recurrent urinary tract infections.\n\nClinical effect of preventive treatment (prophylactic treatment) with the non-pathogenic bacterial strain (ABU) in a selected group of patients with recurrent cystitis: A clinical, placebo-controlled, triple-blinded study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with recurrent cystitis including 2 times of rUTI within the last 6 months or 3 times in the last 12 months, where at least 2 cultures show the same bacteria.\n* Normal investigation for lower urinary tract diseases (LUTD) including voiding diary, symptom scores, flexible cystoscopy, voiding diagram and test for residual urine.\n* Failed previously treatments.\n* Patients with native bladder with both spontaneous voiding, the need for clean intermittent catheter (CIC) or indwelling catheter.\n* Patients with neurogenic and non-neurogenic bladder dysfunction.\n* Patients with urostomy, kidney transplantation or another complicated genesis.\n* Written consent.\n\nExclusion Criteria:\n\n* Malignancy in the urinary tract, kidney-, ureteral- or bladder stones, age \\< 18 years, pregnancy, breastfeeding. Patients in ongoing orally antibiotic treatment. Not able to speak or understand Danish.'}, 'identificationModule': {'nctId': 'NCT04846803', 'acronym': 'BIrUTI', 'briefTitle': 'Bacterial Interference for Preventing Recurrent Urinary Tract Infection - New Ways of Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Bacterial Interference for Preventing Recurrent Urinary Tract Infection - New Ways of Treatment', 'orgStudyIdInfo': {'id': 'BIrUTI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients prophylatic treated with ABU', 'description': 'Patients with prophylactic bladder flushing with an ABU strain.', 'interventionNames': ['Biological: ABU bladder lavage']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Patients control group', 'description': 'The control group with bladder flushing with saline solution.', 'interventionNames': ['Biological: Saline bladder lavage']}], 'interventions': [{'name': 'ABU bladder lavage', 'type': 'BIOLOGICAL', 'description': 'Clinical effect of preventive treatment (prophylactic treatment) - bladder lavage with the non-pathogenic bacterial strain (ABU)', 'armGroupLabels': ['Patients prophylatic treated with ABU']}, {'name': 'Saline bladder lavage', 'type': 'BIOLOGICAL', 'description': 'Clinical effect of preventive treatment (prophylactic treatment) - bladder lavage with saline', 'armGroupLabels': ['Patients control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus N', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Karin U Andersen', 'role': 'CONTACT', 'email': 'karin.andersen@rsyd.dk', 'phone': '+45 21570468'}], 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}, {'zip': '5000', 'city': 'Odense C', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Karin Andersen, MD', 'role': 'CONTACT', 'email': 'karin.andersen@rsyd.dk', 'phone': '+45 21570468'}], 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.40841, 'lon': 10.39538}}], 'centralContacts': [{'name': 'Karin Andersen, MD', 'role': 'CONTACT', 'email': 'karin.andersen@rsyd.dk', 'phone': '+45 21570468'}, {'name': 'Lars Lund, Prof.', 'role': 'CONTACT', 'email': 'lars.lund@rsyd.dk'}], 'overallOfficials': [{'name': 'Karin Andersen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Karin Andersen', 'investigatorAffiliation': 'Odense University Hospital'}}}}