Ignite Creation Date:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2025-12-26 @ 11:47 AM
Study NCT ID:
NCT06659016
Status:
COMPLETED
Last Update Posted:
2024-10-26
First Post:
2024-10-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Collagen, Propolis Plus Quercetin (Proqutin®), Bacillus Coagulans, Hyaluronic Acid and Chondroitin Sulphate and D-Mannose to Avoid Symptoms and Prevents Recurrence in Women With Recurrent Urinary Tract Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014552', 'term': 'Urinary Tract Infections'}, {'id': 'D004194', 'term': 'Disease'}], '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': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005578', 'term': 'Fosfomycin'}, {'id': 'C004469', 'term': 'alloxantin'}], 'ancestors': [{'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants are blind to treatment arm'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-23', 'studyFirstSubmitDate': '2024-10-23', 'studyFirstSubmitQcDate': '2024-10-23', 'lastUpdatePostDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of urinary tract infections per month', 'timeFrame': '6 and 12 months'}], 'secondaryOutcomes': [{'measure': 'ICIQ-FLUTS scores', 'timeFrame': '6 and 12 months'}, {'measure': 'Number of women matching recurrent urinary tract infection criteria', 'timeFrame': '12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urinary Tract Infection (Diagnosis)']}, 'referencesModule': {'references': [{'pmid': '40162673', 'type': 'DERIVED', 'citation': 'Riemma G, Vinci D, La Verde M, Caniglia FM, Scalzone G, Torella M. Adding collagen, propolis plus quercetin, bacillus coagulans, hyaluronic acid and chondroitin sulphate to D-mannose avoids symptoms and prevents recurrence in women with recurrent urinary tract infections: a single-blind randomized controlled trial. Expert Rev Anti Infect Ther. 2025 Jul;23(7):523-530. doi: 10.1080/14787210.2025.2487162. Epub 2025 Apr 3.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate whether a dietary supplement based on D-mannose, collagen, hyaluronic acid, chondroitin sulphate, enhanced by the properties of quercetin plus propolis (Proqutin ®) and Bacillus Coagulans, eventually associated with antimicrobial prophylaxis, could be effective in preventing recurrent UTIs and improving related quality of life.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a history of rUTIs (defined by EAU guidelines as a frequency of at least three UTIs per year, or two UTIs in the past six months in the last 12 months, confirmed by positive urine cultures\n* not undergone any previous treatment for their condition.\n\nExclusion Criteria:\n\n* age under or over limit\n* concurrent antimicrobial treatment\n* any ongoing treatment that could influence study outcomes,\n* congenital or post-surgical urinary tract anomalies\n* immunodeficiency or HIV infection\n* ongoing pregnancy.'}, 'identificationModule': {'nctId': 'NCT06659016', 'acronym': 'IMProBaCist-Q', 'briefTitle': 'Efficacy of Collagen, Propolis Plus Quercetin (Proqutin®), Bacillus Coagulans, Hyaluronic Acid and Chondroitin Sulphate and D-Mannose to Avoid Symptoms and Prevents Recurrence in Women With Recurrent Urinary Tract Infections', 'organization': {'class': 'OTHER', 'fullName': 'University of Campania Luigi Vanvitelli'}, 'officialTitle': "EFFICACIA DI UN INTEGRATORE A BASE DI D-MANNOSIO, PROPOLI, QUERCETINA, COLLAGENE E BACILLUS COAGULANS NEL RIDURRE L'INCIDENZA E MIGLIORARE LA QUALITA' DI VITA IN DONNE CON CISTITE RICORRENTE", 'orgStudyIdInfo': {'id': '10/2024/SCCAL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'interventionNames': ['Drug: Fosfomycin 3 g']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Dietary supplement of D-mannose, collagen, hyaluronic acid, chondroitin sulphate, propolis plus quercetin (Proqutin ®) and Bacillus Coagulans (Uroxin 4G, Pharmasuisse laboratories, Milan, Italy) administered twice daily for seven days in the first month, then once daily for 14 days a month for two months, repeated every three months for a total treatment duration of 12 months.', 'interventionNames': ['Dietary Supplement: Uroxin 4G']}, {'type': 'EXPERIMENTAL', 'label': 'Group C', 'description': 'Combination of treatment A and B', 'interventionNames': ['Drug: Combination of dietary supplement and fosfomycin']}], 'interventions': [{'name': 'Fosfomycin 3 g', 'type': 'DRUG', 'description': 'Fosfomycin trometamol 3 g administered orally in a single dose every ten days for three months, repeated every three months for a total treatment duration of 12 months.', 'armGroupLabels': ['Group A']}, {'name': 'Uroxin 4G', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Dietary supplement of D-mannose, collagen, hyaluronic acid, chondroitin sulphate, propolis plus quercetin (Proqutin ®) and Bacillus Coagulans (Uroxin 4G, Pharmasuisse laboratories, Milan, Italy) administered twice daily for seven days in the first month, then once daily for 14 days a month for two months, repeated every three months for a total treatment duration of 12 months.', 'armGroupLabels': ['Group B']}, {'name': 'Combination of dietary supplement and fosfomycin', 'type': 'DRUG', 'description': 'Fosfomycin trometamol 3 g administered orally in a single dose every ten days for three months, repeated every three months for a total treatment duration of 12 months, combined with an oral formulation of D-mannose, collagen, hyaluronic acid, chondroitin sulphate, propolis plus quercetin (Proqutin ®) and Bacillus Coagulans (Uroxin 4G, Pharmasuisse laboratories, Milan, Italy) administered twice daily for seven days in the first month, then once daily for 14 days a month for two months, repeated every three months for a total treatment duration of 12 months.', 'armGroupLabels': ['Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80138', 'city': 'Napoli', 'country': 'Italy', 'facility': 'University of Campania Luigi Vanvitelli', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Campania Luigi Vanvitelli', 'class': 'OTHER'}, 'collaborators': [{'name': 'pharmaSuisse', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Gaetano Riemma', 'investigatorAffiliation': 'University of Campania Luigi Vanvitelli'}}}}