Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-01-01 @ 6:35 AM
Study NCT ID:
NCT05109533
Status:
COMPLETED
Last Update Posted:
2021-11-05
First Post:
2021-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Probiotics Role in HPV Cervico-vaginal Infection Clearance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014627', 'term': 'Vaginitis'}, {'id': 'D030361', 'term': 'Papillomavirus Infections'}], 'ancestors': [{'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 483}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-04', 'studyFirstSubmitDate': '2021-08-17', 'studyFirstSubmitQcDate': '2021-11-04', 'lastUpdatePostDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of a possible role of probiotics in HPV clearance', 'timeFrame': '12 months', 'description': 'Changes in HPV test positivity'}, {'measure': 'Evaluation in vaginal infection resolution', 'timeFrame': '12 months', 'description': "Negative swab test for vaginal infections, complete symptoms resolution, absence of colposcopy findings suggestive for permanence of infections (e.g. colpitis, fine punctuation, etc), absence of infection following Amsel's criteria"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vaginal infections', 'probiotics', 'HPV'], 'conditions': ['Vaginal Infection', 'HPV Infection']}, 'referencesModule': {'references': [{'pmid': '34155727', 'type': 'BACKGROUND', 'citation': 'Domenici L. Letter to "The application of PAX1 methylation detection and HPV E6/E7 mRNA detection in cervical cancer screening". J Obstet Gynaecol Res. 2021 Sep;47(9):3419-3420. doi: 10.1111/jog.14912. Epub 2021 Jun 21. No abstract available.'}, {'pmid': '29304768', 'type': 'BACKGROUND', 'citation': 'Palma E, Recine N, Domenici L, Giorgini M, Pierangeli A, Panici PB. Long-term Lactobacillus rhamnosus BMX 54 application to restore a balanced vaginal ecosystem: a promising solution against HPV-infection. BMC Infect Dis. 2018 Jan 5;18(1):13. doi: 10.1186/s12879-017-2938-z.'}, {'pmid': '26142892', 'type': 'BACKGROUND', 'citation': 'Recine N, Palma E, Domenici L, Giorgini M, Imperiale L, Sassu C, Musella A, Marchetti C, Muzii L, Benedetti Panici P. Restoring vaginal microbiota: biological control of bacterial vaginosis. A prospective case-control study using Lactobacillus rhamnosus BMX 54 as adjuvant treatment against bacterial vaginosis. Arch Gynecol Obstet. 2016 Jan;293(1):101-107. doi: 10.1007/s00404-015-3810-2. Epub 2015 Jul 5.'}]}, 'descriptionModule': {'briefSummary': 'Vaginal infections demonstrated to be implicated in the persistence of HPV, activating a vicious circle of vaginal microbial perturbations. HPV infection can destroy the biofilm barrier formed by the local vaginal immune microenvironment, leading to a condition called dysbiosis. Contemporarily, the resulting local microecological imbalance in the vagina can subsequently upregulate the expression of the HPV protein, increasing HPV-related cytological alterations.', 'detailedDescription': 'A total of 483 women affected by different vaginal infections and concomitant HPV-positivity were enrolled between 2018 and 2020 at Department of Gynecological, Obstetrical and Urological Sciences, University "Sapienza" of Rome (Rome, Italy) and 2nd Division of Obstetrics and Gynecology, Azienda Ospedaliera Universitaria Pisana, University of Pisa (Pisa, Italy). Women with positive swabs for infections were randomized in two groups, standard specific treatment (n=231) versus the standard treatment plus long-lasting (9 months) vaginal and oral probiotics implementation (n=252).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Vaginal infection as inclusion criteria', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria\n\n* age \\> 18 years\n* positive swabs for vaginal infections detected during colposcopy check\n* HPV test positivity\n\nExclusion Criteria:\n\n* pregnancy or breastfeeding\n* concomitant malignancies\n* immunological diseases\n* severe comorbidities\n* prolonged corticosteroid treatment'}, 'identificationModule': {'nctId': 'NCT05109533', 'briefTitle': 'Probiotics Role in HPV Cervico-vaginal Infection Clearance', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliero, Universitaria Pisana'}, 'officialTitle': 'Probiotics Role in HPV Clearance When Coexisting Vaginal Infections', 'orgStudyIdInfo': {'id': '3644'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Group 1 - ARM WITH STANDARD TREATMENT', 'description': 'Standard specific treatment for vaginal infections following latest version of CDC guidelines'}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 - ARM WITH STANDARD TREATMENT PLUS PROBIOTICS IMPLEMENTATION', 'description': 'Standard specific treatment for vaginal infections plus long-lasting (9 months) vaginal and oral probiotics implementation (Lactobacillus rhamnosus BMX 54 vaginally and Lactobacillus reuteri RC-14/Lactobaciullus rhamnosus GR-1 combination orally)', 'interventionNames': ['Other: Lactobacillus rhamnosus BMX 54, Lactobacillus reuteri RC-14, Lactobacillus rhamnosus GR-1']}], 'interventions': [{'name': 'Lactobacillus rhamnosus BMX 54, Lactobacillus reuteri RC-14, Lactobacillus rhamnosus GR-1', 'type': 'OTHER', 'description': 'Probiotics implementation', 'armGroupLabels': ['Group 2 - ARM WITH STANDARD TREATMENT PLUS PROBIOTICS IMPLEMENTATION']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56120', 'city': 'Pisa', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria Pisana', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliero, Universitaria Pisana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lavinia Domenici', 'investigatorAffiliation': 'Azienda Ospedaliero, Universitaria Pisana'}}}}