Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 8:58 PM
Study NCT ID:
NCT07418918
Status:
COMPLETED
Last Update Posted:
2026-02-18
First Post:
2026-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Live Double Combined Lactobacillus Capsule for Vaginal Use(IIb)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016585', 'term': 'Vaginosis, Bacterial'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014627', 'term': 'Vaginitis'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'This trial employs a double-blind method, meaning that neither the investigator nor the subject knows which treatment the subject is receiving. Both the Vaginal Lactobacillus Dual Probiotic Capsules used in the treatment group and the placebo used in the placebo group are provided by Guangdong Longchuangji Pharmaceutical Co., Ltd. The investigational drug and the control drug are nearly identical in appearance, shape, specification, and dosage.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is a multicenter, randomized, double-blind, placebo-controlled phase IIb clinical trial designed to evaluate the efficacy and safety of Vaginal Lactobacillus Dual Probiotic Capsules in the treatment of bacterial vaginosis. A total of 66 subjects are planned to be enrolled and randomized in a 2:1 ratio into either the treatment group or the placebo group. Specifically, 44 subjects in the treatment group will receive Vaginal Lactobacillus Dual Probiotic Capsules (containing 1×10⁸ CFU per capsule), while 22 subjects in the placebo group will receive a placebo.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2023-11-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-11', 'studyFirstSubmitDate': '2026-02-04', 'studyFirstSubmitQcDate': '2026-02-11', 'lastUpdatePostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Vaginal Lactobacillus Colonization Rate', 'timeFrame': 'Day 21 to Day 30'}], 'primaryOutcomes': [{'measure': 'Clinical Cure Rate', 'timeFrame': 'Day 21 to Day 30', 'description': 'Clinical cure is defined as follows: vaginal secretions return to normal physiological secretions; whiff test is negative; clue cells are negative (i.e., the number of clue cells is less than 20% of the total number of vaginal epithelial cells)'}], 'secondaryOutcomes': [{'measure': 'Clinical Cure Rate', 'timeFrame': 'Day 15 to Day 18', 'description': 'Clinical cure is defined as follows: vaginal secretions return to normal physiological secretions; whiff test is negative; clue cells are negative (i.e., the number of clue cells is less than 20% of the total number of vaginal epithelial cells).'}, {'measure': 'Bacteriological Cure Rate', 'timeFrame': 'Day 15 to Day 18', 'description': 'Bacteriological cure is defined as a Nugent score of less than 4'}, {'measure': 'Composite Cure Rate', 'timeFrame': 'Day 15 to Day 18', 'description': 'Comprehensive cure is defined as meeting both clinical cure and bacteriological cure.'}, {'measure': 'Bacteriological Cure Rate', 'timeFrame': 'Day 21 to Day 30', 'description': 'Bacteriological cure is defined as a Nugent score of less than 4'}, {'measure': 'Composite Cure Rate', 'timeFrame': 'Day 21 to Day 30', 'description': 'Comprehensive cure is defined as meeting both clinical cure and bacteriological cure.'}, {'measure': 'Incidence of treatment-emergent adverse events (Safety Evaluation)', 'timeFrame': 'Through study completion, an average of 30 days', 'description': 'A treatment-emergent adverse event was defined as any adverse event occurring on or after the first use of the investigational product, regardless of causality.'}, {'measure': 'Incidence of treatment-related adverse events (Safety Evaluation)', 'timeFrame': 'Through study completion, an average of 30 days', 'description': 'A treatment-related adverse events referred to any treatment-emergent adverse events with causal association to the treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Probiotics', 'Lactobacillus gasseri', 'Lactobacillus rhamnosus', 'Bacterial vaginosis', 'Multicenter study'], 'conditions': ['Bacterial Vaginosis']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, randomized, double-blind, placebo-controlled phase IIb clinical study, to evaluate the efficacy and safety of the dual - live Lactobacilli-containing vaginal capsule for the treatment of bacterial vaginosis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. The subject fully understands the purpose, nature, methods, and potential adverse reactions of the trial, voluntarily participates in the study, and provides written informed consent prior to trial commencement;\n2. Female aged 18 to 50 years (inclusive of the boundary values);\n3. History of sexual activity, willing to undergo vaginal administration of medication, and agrees to refrain from using other intravaginal products (e.g., contraceptive creams, gels, foams, sponges, lubricants, douches, tampons, etc.) and from engaging in sexual activity throughout the entire trial period;\n4. Has a normal and regular menstrual cycle;\n5. Clinically diagnosed with bacterial vaginosis (BV), defined as having at least three positive findings on Amsel's criteria, including the presence of clue cells (i.e., clue cells accounting for \\>20% of the total vaginal epithelial cells); and a Nugent score ≥ 7 points.\n\nExclusion Criteria:\n\n1. Known allergy to any component of the investigational drug;\n2. Known current diagnosis of pelvic inflammatory disease, cervicitis, or acute urogenital infection;\n3. Vulvovaginitis due to other infectious etiologies, such as vulvovaginal candidiasis (VVC), trichomonal vaginitis (TV), aerobic vaginitis (AV score ≥5), gonorrhea, or Chlamydia trachomatisinfection,etc;\n4. Pelvic examination at screening reveals the presence of condyloma acuminata (genital warts);\n5. History of complicated or recurrent VVC within 1 year prior to screening;\n6. Known diagnosis of uterine fibroids or adenomyosis requiring intervention as assessed by the investigator;\n7. Vaginal speculum examination at screening indicates significant vaginal mucosal injury (e.g., mucosal edema, ulceration, erosion);\n8. History of significant diseases affecting the cardiovascular, hepatic, renal, pulmonary, gastrointestinal, neurological, metabolic, urogenital, endocrine, or psychiatric systems, which in the investigator's judgment may compromise subject safety;\n9. Use of vaginal douching or other intravaginal treatments (e.g., products such as Jie Er Yin, Jie Yin Kang) within 72 hours prior to dosing or anticipated use during the trial period;\n10. Received antibiotic or antifungal treatment (systemic and/or intravaginal) within 2 weeks prior to dosing;\n11. Current use of long-acting contraceptive injections or oral contraceptives at screening;\n12. History of gynecological surgery within 2 months prior to screening;\n13. Positive virological tests for syphilis or HIV at screening;\n14. Positive pregnancy test at screening; or history of pregnancy termination within 2 months prior to screening; or women of childbearing potential who, in the investigator's judgment, cannot use a medically approved and reliable contraceptive method from the time of signing the informed consent until 3 months after the last dose of the study drug;\n15. Women who are pregnant or breastfeeding;\n16. Participation in any other drug or medical device clinical trial within 3 months prior to dosing, involving the use of investigational drugs or devices; Any other medical condition that, in the investigator's judgment, may affect the assessment of the study."}, 'identificationModule': {'nctId': 'NCT07418918', 'acronym': 'BV', 'briefTitle': 'Live Double Combined Lactobacillus Capsule for Vaginal Use(IIb)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Guangdong Longchuangji Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study on the Efficacy and Safety of Lactobacillus Bicomponent Viable Capsules for Vaginal Use in the Treatment of Bacterial Vaginosis', 'orgStudyIdInfo': {'id': 'CTS-CO-2417'}, 'secondaryIdInfos': [{'id': 'CTS-CO-2417', 'type': 'REGISTRY', 'domain': 'ClinicalTrials.gov'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vaginal Lactobacillus Dual Probiotic Capsules', 'interventionNames': ['Drug: Vaginal Lactobacillus Dual Probiotic Capsules']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Vaginal Lactobacillus Dual Probiotic Capsules', 'type': 'DRUG', 'description': 'Vaginal Lactobacillus Dual Probiotic Capsules, at the prescribed dose and course of treatment, for regulating vaginal microecology.', 'armGroupLabels': ['Vaginal Lactobacillus Dual Probiotic Capsules']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo capsule with the same appearance as the study drug, at the same dose and course of treatment as the experimental group.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '521000', 'city': 'Chaozhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangdong Longchuangji Pharmaceutical Co., Ltd.', 'geoPoint': {'lat': 23.65396, 'lon': 116.62262}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangdong Longchuangji Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}