Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 1:16 AM
Study NCT ID:
NCT07435350
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-12
First Post:
2026-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial to Assess the Pharmacokinetics and Pharmacodynamics of a Novel Synbiotic Oral Supplement for Vaginal Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': "Double (Participant, Investigator): The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received."}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment. Participants will be sequentially randomized to one of two study groups, with an equal (1:1) chance of receiving the study product or placebo'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-26', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-02-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-10', 'studyFirstSubmitDate': '2026-02-20', 'studyFirstSubmitQcDate': '2026-02-20', 'lastUpdatePostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Vaginal pH', 'timeFrame': 'Baseline to Day 14', 'description': 'pH measurements of vaginal fluid using pH strips'}], 'primaryOutcomes': [{'measure': 'Colonization of VV-01 probiotic strains in the vagina', 'timeFrame': 'Baseline to Day 14', 'description': 'Colonization of VV-01 probiotic strains in the vagina assessed using strain-specific qPCR from vaginal swabs'}], 'secondaryOutcomes': [{'measure': 'Vaginal microbial ecosystem structure', 'timeFrame': 'Baseline to Day 14', 'description': 'Structure of the vaginal microbiome assessed by metagenomic sequencing of vaginal swabs'}, {'measure': 'Biogenic amines production capability in the vaginal microbiome', 'timeFrame': 'Baseline to Day 14', 'description': 'Biogenic amines production capability assessed by metagenomic sequencing (functional genomics) of vaginal swabs'}, {'measure': 'Safety and tolerability', 'timeFrame': 'Baseline to Day 14', 'description': 'Safety and tolerability assessed through observation of serious adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vaginal Health']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.radiclescience.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'A randomized, placebo-controlled trial to assess the Pharmacokinetics and Pharmacodynamics of a novel synbiotic dietary supplement for vaginal health.', 'detailedDescription': 'This is a randomized, double-blind, placebo-controlled, decentralized clinical trial that will enroll approximately 200 healthy women aged 21-60 years old who meet all eligibility criteria. Eligible participants will be stratified based on key factors.\n\nFollowing stratification, participants will be randomized to one of the study arms (placebo or VV-01 product) using block randomization. Participants will have a 1:1 chance of receiving the active study product or the placebo.\n\nParticipants will receive study kits containing the study product, administration supplies, biomarker self-collection materials, and comprehensive instructions for product use and sample collection.\n\nThe duration of the study for each participant will be approximately 2 weeks following enrollment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria\n\nParticipants must meet all the following criteria:\n\n* Healthy women with a vagina 21 - 60 years old at the time of electronic consent\n* Sex assigned female at birth\n* Eligible menstrual status:\n\n * Pre-menopausal is defined as women in their childbearing years who must have a regular menstrual cycle (consistently average cycle length of 21 to 35 days) Note: Women in their childbearing years who do not have a regular menstrual cycle due to a hormone-based intrauterine device are eligible\n * Peri-menopausal is defined as women who report irregular periods (differences in menstruation compared with their typical cycle in their 20s), with at least 1 period in the last 12 months AND report mild menopausal symptoms (e.g., vasomotor symptoms such as hot flashes, night sweats)\n * Post-menopausal is defined as women with an absence of menstrual cycle for the last 12 consecutive months or longer\n* Willing to ingest an oral capsule during the study and be blinded to product identity (active or placebo)\n* Willing to self-collect vaginal swabs and pH samples\n* Willing to abstain from the use of intravaginal products during the study period (e.g., vaginal suppositories, vaginal moisturizers including hyaluronic acid, boric acid suppositories, pH balancing wipes, douching, vaginal creams/gels), as well as lubrication and spermicides\n* Able to read and comprehend English and provide electronic informed consent\n* Resides in the United States\n\nExclusion criteria\n\n* Active vaginal, pelvic, or urogenital infection (e.g., UTI, BV, yeast infection)\n* Chronic vulvar and vaginal conditions (e.g., vulvodynia, lichen sclerosis and lichen planus, desquamative inflammatory vaginitis)\n* Unexplained vaginal bleeding\n* Use of copper-based intrauterine devices\n\n * Note: Hormone-based intrauterine devices are permitted (e.g., Mirena®)\n* For peri-menopausal and post-menopausal individuals, use of estrogen-based vaginal cream/gel or suppositories\n* Women who have undergone surgical menopause (e.g., bilateral oophorectomy with or without hysterectomy)\n* Current or recent use (\\< 3 months prior to enrollment) of antibiotics or antifungals, or anticipated use during study period (e.g., perioperative antibiotics for upcoming elective procedures)\n* Current or recent use (\\<4 weeks prior to enrollment) of any other probiotic, prebiotic or synbiotic-containing products\n\n * Note: Individuals who undergo a washout of 4-weeks prior to enrollment and are willing to abstain from consuming such products during the study are permitted. Food-based probiotics, prebiotics, and synbiotics are permitted (e.g., kimchi, yoghurt, kefir, kombucha)\n* Pregnant, breastfeeding, or actively trying to conceive during the study period.\n* Allergy to any ingredients in the investigational or placebo product.\n* Receiving chronic oral steroid therapy (excluding those for skin, eyes, nose, or inhaled) or have received such treatment within 4 weeks of enrollment\n* Surgery, immunotherapy, chemotherapy, radiation, or biological cancer therapy within 4 weeks of enrollment and/or planned during the next 2 weeks\n* Diagnosed and active serious medical condition requiring current treatment (e.g., cancer; autoimmune diseases \\[lupus, rheumatoid arthritis, Crohn's disease\\]; serious cardiac, liver, endocrine (insulin-dependent diabetes and/or on SGLT2 inhibitors such as Jardiance®/Empagliflozin, Farxiga®/Dapagliflozin) or kidney disease; psychiatric conditions / substance use disorders; chronic infections \\[HIV, Hepatitis B/C\\], any condition which in the investigator's opinion may jeopardize the individual's safety or interfere with the ability to comply with the study\n* Participation in another clinical trial within 90 days of screening\n* International travel during the study period"}, 'identificationModule': {'nctId': 'NCT07435350', 'briefTitle': 'A Trial to Assess the Pharmacokinetics and Pharmacodynamics of a Novel Synbiotic Oral Supplement for Vaginal Health', 'organization': {'class': 'INDUSTRY', 'fullName': 'Radicle Science'}, 'officialTitle': 'A Randomized, Placebo-Controlled Trial to Assess the Pharmacokinetics and Pharmacodynamics of a Novel Synbiotic Oral Supplement for Vaginal Health', 'orgStudyIdInfo': {'id': 'RADX_C026_DSH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active VV-01', 'description': 'Vaginal Health Active VV-01', 'interventionNames': ['Dietary Supplement: Vaginal Health Active VV-01']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Control', 'description': 'Vaginal Health Placebo Control', 'interventionNames': ['Dietary Supplement: Vaginal Health Placebo Control']}], 'interventions': [{'name': 'Vaginal Health Placebo Control', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Vaginal Health Placebo Control Participants will orally ingest Vaginal Health Placebo Control once daily as directed for a period of 2 weeks', 'armGroupLabels': ['Placebo Control']}, {'name': 'Vaginal Health Active VV-01', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Product 1 Participants will orally ingest Vaginal Health Active Product 1 once daily as directed for a period of 2 weeks.', 'armGroupLabels': ['Active VV-01']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92014-2605', 'city': 'Del Mar', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Study Manager', 'role': 'CONTACT', 'email': 'studymgmt@radiclescience.com', 'phone': '760-281-3898'}, {'name': 'Megan Moseley', 'role': 'CONTACT', 'email': 'megan@radiclescience.com'}], 'facility': 'Radicle Science Inc.', 'geoPoint': {'lat': 32.95949, 'lon': -117.26531}}], 'centralContacts': [{'name': 'Study Manager', 'role': 'CONTACT', 'email': 'studymgmt@radiclescience.com', 'phone': '858-779-0086'}, {'name': 'Susan Hewlings', 'role': 'CONTACT', 'email': 'susan.hewlings@radiclescience.com', 'phone': '760-281-3898'}], 'overallOfficials': [{'name': 'Susan Hewlings', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radicle Science'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will not be shared with researchers outside of Radicle Collaborators on this study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radicle Science', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}