Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-03-20 @ 2:07 AM
Study NCT ID:
NCT06506357
Status:
COMPLETED
Last Update Posted:
2024-07-17
First Post:
2024-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single Group Study to Evaluate the Effects of a Probiotic Supplement on Vaginal Health.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-11', 'studyFirstSubmitDate': '2024-07-11', 'studyFirstSubmitQcDate': '2024-07-11', 'lastUpdatePostDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vaginal and Urinary Tract Health and Balance', 'timeFrame': 'Baseline, Week 2, Week 4, Week 6, Week 8', 'description': 'Assessment of vaginal and urinary tract health and balance through questionnaires completed by participants at Baseline, after the first dose, and at the end of Weeks 2, 4, 6, and 8.'}], 'secondaryOutcomes': [{'measure': 'Vaginal Environment and Odor', 'timeFrame': 'Baseline, Week 2, Week 4, Week 6, Week 8', 'description': 'Assessment of the vaginal environment and odor through questionnaires completed by participants at Baseline, after the first dose, and at the end of Weeks 2, 4, 6, and 8.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Probiotic Supplement', 'Urinary Tract Health'], 'conditions': ['Vaginal Health', "Women's Health"]}, 'descriptionModule': {'briefSummary': 'This virtual single-group clinical trial aims to evaluate the effects of the Good Girl Probiotics supplement on vaginal health. Participants will take one capsule of the probiotic supplement daily for eight weeks. They will complete questionnaires at Baseline, after the first dose, and at the end of Weeks 2, 4, 6, and 8 to assess changes in vaginal pH, vaginal health, and urinary tract health.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female at birth.\n* Aged 18+.\n* Interested in supporting a balanced vaginal pH, vaginal health, and urinary tract health.\n* Regularly experience symptoms of an unbalanced vagina, including an atypical smell, discharge, itching, swelling, irritation, pain during sex, and/or burning sensation while urinating.\n* Willing to avoid using products or medications that target vaginal or urinary tract health infections.\n* Willing to avoid other probiotics.\n* Able to follow the study protocol.\n\nExclusion Criteria:\n\n* Two or more bladder infections in six months or three or more infections in a year.\n* Recent surgeries or invasive treatments within the last six months.\n* Use of products or medications targeting vaginal or urinary tract health in the last 12 weeks.\n* Known allergies to the product ingredients.\n* Chronic health conditions impacting participation.\n* Pregnant, breastfeeding, or trying to conceive.\n* History of substance abuse.\n* Current or former smoker within the past six months.\n* Participation in another clinical trial.\n* Diagnosed vaginal or pelvic conditions.\n* Use of vaginal-related birth control (NuvaRing, IUD).\n* Changes in hormonal birth control in the last three months.'}, 'identificationModule': {'nctId': 'NCT06506357', 'briefTitle': 'A Single Group Study to Evaluate the Effects of a Probiotic Supplement on Vaginal Health.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Love Wellness'}, 'officialTitle': 'A Single Group Study to Evaluate the Effects of a Probiotic Supplement on Vaginal Health.', 'orgStudyIdInfo': {'id': '20433'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic Supplement Group', 'description': 'Participants in this group will receive the Good Girl Probiotics supplement.', 'interventionNames': ['Dietary Supplement: Good Girl Probiotics']}], 'interventions': [{'name': 'Good Girl Probiotics', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will take one capsule of the Good Girl Probiotics supplement daily in the morning for eight weeks.', 'armGroupLabels': ['Probiotic Supplement Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Citruslabs', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Love Wellness', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Citruslabs', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}