Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2025-12-30 @ 9:29 PM
Study NCT ID:
NCT05176535
Status:
COMPLETED
Last Update Posted:
2025-12-04
First Post:
2021-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determination of Vaginal Colonization and the Effect of an Oral Probiotic (PROSALVAG)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D064806', 'term': 'Dysbiosis'}, {'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2021-11-30', 'studyFirstSubmitQcDate': '2021-12-14', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rectal and vaginal colonization', 'timeFrame': '10 weeks', 'description': 'Rectal and vaginal colonization will be evaluated by measuring massive sequencing of 16SrRNA gen'}], 'secondaryOutcomes': [{'measure': 'Autoinmune capacity', 'timeFrame': '10 weeks', 'description': 'Autoinmune capacity will be evaluated by measuring plasma levels of IL-10, TNF- alpha and IL-10'}, {'measure': 'Antioxidant effect', 'timeFrame': '10 weeks', 'description': 'Antioxidant will be evaluated by measuring Total Antioxidant Capacity (TAC) and Malondialdehyde'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Microbial Colonization', 'Dysbiosis', 'Fertility Issues']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the efficacy of an oral nutraceutical with probiotics in restore vaginal health.', 'detailedDescription': 'After being informed about the study, all patients meeting the inclusion/exclusion criteria and giving written informed consent will receive a nutraceutical containing L. rhamnosus, L. plantarum and L. crispatus once daily.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '43 Years', 'minimumAge': '35 Years', 'genderBased': True, 'genderDescription': 'Restoration of vaginal microbiota', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged: 35-43 years old\n* Vaginal pH \\> 4,5 and low Lactobacillus count or Nugent score of 4-6\n* With interest in getting pregnant and ideally in IVF waiting list\n* History of recurrent genitourinary infections\n\nExclusion Criteria:\n\n* Any pathology that interferes with the study\n* Current intake of food supplements or probiotics\n* Current intake of contraceptives\n* Use of oral or vaginal probiotics in the last 6 months\n* Hypersensitivity to any of the components of the studied product\n* Current vaginal infection\n* Pregnant women\n* Breastfeeding\n* Use of intrauterine device\n* Use of spermicide\n* Use of cervical caps as hormonal therapy'}, 'identificationModule': {'nctId': 'NCT05176535', 'acronym': 'PROSALVAG', 'briefTitle': 'Determination of Vaginal Colonization and the Effect of an Oral Probiotic (PROSALVAG)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fertypharm'}, 'officialTitle': 'Study to Determine Vaginal Colonization and Effect of an Oral Probiotic That Contains L.Rhamnosus, L. Plantarum and L. Crispatus in Women (PROSALVAG)', 'orgStudyIdInfo': {'id': '2021-FBB-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FertyBiotic Balance', 'description': 'Participants received FertyBiotic Balance one capsule a day', 'interventionNames': ['Dietary Supplement: FertyBiotic Balance']}], 'interventions': [{'name': 'FertyBiotic Balance', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Lactobacillus rhamnosus BPL 205, Lactobacillus plantarum BPL207 and Lactobacillus crispatus BPL209', 'armGroupLabels': ['FertyBiotic Balance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28801', 'city': 'Alcalá de Henares', 'state': 'Madrid', 'country': 'Spain', 'facility': 'HM Fertility Centter Vallés', 'geoPoint': {'lat': 40.48205, 'lon': -3.35996}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fertypharm', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}