Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-01-29 @ 8:30 PM
Study NCT ID:
NCT03644966
Status:
COMPLETED
Last Update Posted:
2023-04-12
First Post:
2018-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Probiotics and Multi-Drug Resistant Urinary Tract Infection
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000900', 'term': 'Anti-Bacterial Agents'}], 'ancestors': [{'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-10', 'studyFirstSubmitDate': '2018-08-06', 'studyFirstSubmitQcDate': '2018-08-22', 'lastUpdatePostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Resistance Pattern', 'timeFrame': '6-8 weeks after initial dose', 'description': 'The change in the quantity of antibiotics reported to be resistant per organism per culture per patient.'}, {'measure': 'Bacterial isolate genomic characteristics', 'timeFrame': '12 months after initial dose', 'description': 'genomic sequencing of bacterial isolates to determine genetic identity'}], 'secondaryOutcomes': [{'measure': 'UTI reduction', 'timeFrame': '12 months after initial dose', 'description': 'The quantity of reduction of all urinary tract infections (UTI) in treatment arm vs. placebo from baseline.'}, {'measure': 'Antibiotics Quantity', 'timeFrame': '12 months after initial dose', 'description': 'The quantity of antibiotics prescribed in treatment arm vs. placebo.'}, {'measure': 'Healthcare visit', 'timeFrame': '12 months after initial dose', 'description': 'The quantity of ER visits/urgent care visits/hospitalizations/outpatient clinic visits in treatment arm vs. placebo.'}, {'measure': 'Length of time for change in resistance', 'timeFrame': '12 months after initial dose', 'description': 'The amount of time it takes to note changes in antibiotic sensitivity patterns while on the treatment arm.'}, {'measure': 'Sensitivity pattern post-probiotic therapy', 'timeFrame': '12 months after initial dose', 'description': 'The change in the quantity of antibiotics reported to be resistant per organism'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Probiotics', 'multi-drug resistant UTI', 'recurrent UTI'], 'conditions': ['Urinary Tract Infections', 'Recurrent UTI', 'Antibiotic Resistant Infection']}, 'referencesModule': {'references': [{'pmid': '24847423', 'type': 'BACKGROUND', 'citation': 'Naderi A, Kasra-Kermanshahi R, Gharavi S, Imani Fooladi AA, Abdollahpour Alitappeh M, Saffarian P. Study of antagonistic effects of Lactobacillus strains as probiotics on multi drug resistant (MDR) bacteria isolated from urinary tract infections (UTIs). Iran J Basic Med Sci. 2014 Mar;17(3):201-8.'}, {'pmid': '26695595', 'type': 'BACKGROUND', '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': '28480273', 'type': 'BACKGROUND', 'citation': 'Simmering JE, Tang F, Cavanaugh JE, Polgreen LA, Polgreen PM. The Increase in Hospitalizations for Urinary Tract Infections and the Associated Costs in the United States, 1998-2011. Open Forum Infect Dis. 2017 Feb 24;4(1):ofw281. doi: 10.1093/ofid/ofw281. eCollection 2017 Winter.'}, {'pmid': '29170359', 'type': 'BACKGROUND', 'citation': 'Barclay J, Veeratterapillay R, Harding C. Non-antibiotic options for recurrent urinary tract infections in women. BMJ. 2017 Nov 23;359:j5193. doi: 10.1136/bmj.j5193. No abstract available.'}, {'pmid': '29487733', 'type': 'BACKGROUND', 'citation': 'Vahedi-Shahandashti R, Kasra-Kermanshahi R, Shokouhfard M, Ghadam P, Feizabadi MM, Teimourian S. Antagonistic activities of some probiotic lactobacilli culture supernatant on Serratia marcescens swarming motility and antibiotic resistance. Iran J Microbiol. 2017 Dec;9(6):348-355.'}, {'pmid': '26955289', 'type': 'BACKGROUND', 'citation': 'Lau CS, Chamberlain RS. Probiotics are effective at preventing Clostridium difficile-associated diarrhea: a systematic review and meta-analysis. Int J Gen Med. 2016 Feb 22;9:27-37. doi: 10.2147/IJGM.S98280. eCollection 2016.'}, {'pmid': '9125655', 'type': 'BACKGROUND', 'citation': "Favier C, Neut C, Mizon C, Cortot A, Colombel JF, Mizon J. Fecal beta-D-galactosidase production and Bifidobacteria are decreased in Crohn's disease. Dig Dis Sci. 1997 Apr;42(4):817-22. doi: 10.1023/a:1018876400528."}, {'pmid': '21292654', 'type': 'BACKGROUND', 'citation': 'Gupta K, Hooton TM, Naber KG, Wullt B, Colgan R, Miller LG, Moran GJ, Nicolle LE, Raz R, Schaeffer AJ, Soper DE; Infectious Diseases Society of America; European Society for Microbiology and Infectious Diseases. International clinical practice guidelines for the treatment of acute uncomplicated cystitis and pyelonephritis in women: A 2010 update by the Infectious Diseases Society of America and the European Society for Microbiology and Infectious Diseases. Clin Infect Dis. 2011 Mar 1;52(5):e103-20. doi: 10.1093/cid/ciq257.'}]}, 'descriptionModule': {'briefSummary': 'This pilot study is a single-site randomized, double blinded placebo-controlled in females with recurrent multi-drug resistant (MDR) urinary tract infections(UTI). Our study hypothesizes that a novel probiotic strain improves antibiotic sensitivity patterns in these former MDR UTIs.', 'detailedDescription': 'The aims of this study are (1) to evaluate the effects of six months of probiotic therapy in addition to standard of care in changing sensitivity patterns of MDR bacteria causing recurrent UTI, (2) analyze the genetic composition of MDR bacterial isolates causing recurrent UTI before and after administration of probiotic vs. placebo, with standard of care antibiotics.\n\nStudy subjects will be asked to take a either a probiotic supplement or placebo at a dose of 1 caplet per day for 24 weeks in addition to antibiotic regimen. Subjects will be followed for 12 months. The outcome measure is the percent of probiotic ingestors vs placebo ingestors who experience a change in antibiotic susceptibility over this time period. The secondary outcome measure is the evaluation of genetic composition of bacteria recurring after probiotic vs. placebo administration.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female, age 18-90\n* Ability to void spontaneously\n* Suffers from recurrent multi-drug resistant or extensively drug resistant urinary tract infections caused by E.coli, Klebsiella, Enterococcus, Citrobacter, Proteus, Enterobacter, Serratia and Providencia.\n\nExclusion Criteria:\n\n* Has staghorn renal calculi, chronic hydronephrosis, intermittent catherization, indwelling urinary catheters, urinary diversions, end stage renal disease on hemodialysis, transplantation, HIV, cirrhosis, pancreatitis, allergy to soy or milk/milk proteins or lactose intolerance\n* Pregnant or breastfeeding\n* Currently taking probiotics. 4 week washout.'}, 'identificationModule': {'nctId': 'NCT03644966', 'briefTitle': 'Probiotics and Multi-Drug Resistant Urinary Tract Infection', 'organization': {'class': 'OTHER', 'fullName': 'Ochsner Health System'}, 'officialTitle': 'Probiotic and Effects on Multi-Drug Resistant Urinary Tract Infection', 'orgStudyIdInfo': {'id': '2017564'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic + Antibiotic', 'description': '50 subjects to receive probiotic supplement once daily for 6 months in capsule form, in addition to standard antibiotic regimen for treatment of UTI.', 'interventionNames': ['Dietary Supplement: Bifidobacterium infantis', 'Drug: Antibiotics']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo + Antibiotic', 'description': '50 subjects to receive placebo once daily for 6 months in capsule form, in addition to antibiotic regimen for treatment of UTI.', 'interventionNames': ['Other: Placebo', 'Drug: Antibiotics']}], 'interventions': [{'name': 'Bifidobacterium infantis', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Align'], 'description': 'Probiotics', 'armGroupLabels': ['Probiotic + Antibiotic']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['Placebo (for Probiotic)'], 'description': 'Sugar pill manufactured to mimic probiotic tablet', 'armGroupLabels': ['Placebo + Antibiotic']}, {'name': 'Antibiotics', 'type': 'DRUG', 'description': 'Per Infectious Disease Society guidelines for Antimicrobial treatment of uncomplicated cystitis and pyelonephritis in women', 'armGroupLabels': ['Placebo + Antibiotic', 'Probiotic + Antibiotic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70121', 'city': 'Jefferson', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Health System', 'geoPoint': {'lat': 29.96604, 'lon': -90.15313}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ochsner Health System', 'class': 'OTHER'}, 'collaborators': [{'name': 'Procter and Gamble', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}