Ignite Creation Date:
2025-12-24 @ 12:00 PM
Ignite Modification Date:
2026-01-10 @ 7:35 PM
Study NCT ID:
NCT07246161
Status:
RECRUITING
Last Update Posted:
2025-11-26
First Post:
2025-11-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaginal Detection of Orally Delivered Probiotic Strains in Healthy Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2025-11-13', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of adverse events (AEs) and serious adverse events (SAEs) reported throughout the study.', 'timeFrame': 'From enrollment to the 35th day'}], 'primaryOutcomes': [{'measure': 'Presence or absence of probiotic stains in vaginal swabs after 28 days of oral intake', 'timeFrame': '28 days of oral intake'}], 'secondaryOutcomes': [{'measure': 'Presence or absence of the probiotic stains in the vaginal swabs at days 0 & 14 of oral intake, and 1 week after the end of intervention (Day 35)', 'timeFrame': 'From enrollment to day 35'}, {'measure': 'Presence or absence of the probiotic strains in perineal skin swabs at days 0, 14, and 28 of oral intake.', 'timeFrame': 'From enrollment to the 28th day.'}, {'measure': 'Presence or absence of the probiotic strains in stool samples at days 0, 14 and 28 of oral intake.', 'timeFrame': 'From enrollment to 28th day'}, {'measure': 'Viability of the probiotic strains recovered from vaginal swabs at days 0, 14, and 28 of oral intake, and 1 week after the end of the intervention (Day 35)', 'timeFrame': 'From enrollment to the 35th day.'}, {'measure': 'Viability of the probiotic strains recovered from perineal skin swabs at day 0, 14, and 28 of oral intake.', 'timeFrame': 'From enrollment to 28th day'}, {'measure': 'Changes in vaginal pH from baseline to 1 week after the end of the intervention (Day 35)', 'timeFrame': 'From baseline to day 35.'}, {'measure': 'Changes in the abundance of endogenous and pathogenic bacterial and fungal species in the vagina at days 0, 14, 28 and 35.', 'timeFrame': 'From enrollment to the 35th day'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Probiotics', "Women's Health"], 'conditions': ['Focus is on Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'The purpose of the present study is to obtain more information on the transit of orally ingested probiotics to the vagina.', 'detailedDescription': "Probiotics have emerged as novel supplements to support women's health, demonstrating benefits in maintain vaginal health and promoting recovery from dysbiosis. This includes various oral and vaginal probiotics shown to alleviate symptoms and enhance the reversal of vaginal dysbiosis.\n\nOral delivered probiotic strains suggest their ability to migrate and colonize the vagina to support vaginal health but is not well understood. Therefore, this study will aim to provide additional information on their transit to the vagina."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinically healthy female between the ages of 18 and 50 years, inclusive,\n* have a regular or predictable menstrual cycle\n* Typically have regular bowel movements,\n* Willing and able to consume a probiotic supplement for 4 weeks,\n* Willing to discontinue consumption of probiotic supplement and probiotic-fortified products 2 weeks before the start of the study and throughout the study,\n* Willing to discontinue fiber supplements 2 weeks before the start of the study, and throughout the study,\n* Willing to provide 1 stool sample 4 times throughout the study,\n* Willing to provide 2 vaginal swabs 4 times throughout the study,\n* Willing to undergo vaginal pH swab measurements (with a swab) 5 times throughout the study,\n* Willing to provide 2 perineal skin swabs (skin between the vagina and the anus) 3 times throughout the study,\n* Willing to complete a pregnancy test at the screening visit.\n\nExclusion Criteria:\n\n* Menopausal women,\n* Vaginal pH \\< 2 or \\> 5 measured at screening,\n\n •. Menstruation during the sample collection times,\n* Women that are lactating, pregnant, attempting to get pregnant, or have a positive pregnancy test,\n* Use of vaginal probiotics in the last 3 months,\n* Use of local vaginal antibiotics or antifungals in the last 3 months.\n* Use of oral antibiotics or antifungals in the last month,\n* Ongoing symptoms of vaginal and/or urinary tract infections,\n* Current treatment for vaginal sepsis or urosepsis,\n* Currently being treated for a severe chronic disease (e.g. cancer, renal failure, chronic inflammatory digestive or gastro-intestinal disease, immunodeficiency, etc.),\n* Clinical diagnosis of a gynecological disease or condition (e.g, fibroma, endometriosis, polycystic ovarian syndrome, etc.),\n* Clinical diagnosis of secondary dysmenorrhea,\n* Intolerance, allergy or sensitivity to milk, soy, or yeast.'}, 'identificationModule': {'nctId': 'NCT07246161', 'acronym': 'VSS2', 'briefTitle': 'Vaginal Detection of Orally Delivered Probiotic Strains in Healthy Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lallemand Health Solutions'}, 'officialTitle': 'Detection of Orally Delivered Probiotic Strains in the Vaginal Microbiome of Healthy Female Adults', 'orgStudyIdInfo': {'id': 'L-032'}, 'secondaryIdInfos': [{'id': '25AQ-1030', 'type': 'OTHER', 'domain': 'CRO Study Number. Evalulab'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'interventionNames': ['Other: Probiotic Formula 1']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'interventionNames': ['Other: Probiotic Formula 2']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'interventionNames': ['Other: Probiotic Formula 3']}], 'interventions': [{'name': 'Probiotic Formula 1', 'type': 'OTHER', 'description': 'Includes 2 different probiotic strains differing from other intervention groups.', 'armGroupLabels': ['Group 1']}, {'name': 'Probiotic Formula 2', 'type': 'OTHER', 'description': 'Includes 2 different probiotic strains differing from other intervention groups.', 'armGroupLabels': ['Group 2']}, {'name': 'Probiotic Formula 3', 'type': 'OTHER', 'description': 'Includes 2 different probiotic strains differing from other intervention groups.', 'armGroupLabels': ['Group 3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Montreal', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Evalulab', 'role': 'CONTACT', 'phone': '514-434-0001'}], 'facility': 'Evalulab', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Jenna Bouassaly, MSc', 'role': 'CONTACT', 'email': 'jbouassaly@lallemand.com', 'phone': '5142835428'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lallemand Health Solutions', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}