[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07305844":3,"trial-entities:NCT07305844":79,"trial-summary:NCT07305844":82},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":40,"sex":41,"minimum_age":42,"maximum_age":43,"healthy_volunteers":15,"eligibility_criteria":44,"std_ages":53,"locations":55,"central_contacts":69,"overall_officials":70,"references":77,"see_also_links":78},"NCT07305844","VMRC-002","Impact of Clinician-administered Vaginal Live Biotherapeutic Product","Open-label, Single-arm Study to Assess the Colonization Kinetics of Clinician- Administered Vaginal Live Biotherapeutic Product Containing Multiple Strains of Lactobacillus Crispatus.","COMPLETED","2026-08-13","2026-08","2026-08-19","2026-04-28","Caroline Mitchell","OTHER",false,"This is an open-label, single-arm, Phase Ib trial assessing the consistency of response and colonization kinetics of a vaginally inserted live biotherapeutic intervention with optimized adherence.","In this study investigators will enroll participants from the VIBRANT study who received active study product and test the vaginal microbiome. If a participant does not have a Lactobacillus predominant vaginal microbiome, they will re-dose with LC106 in the clinic for three days in a row. This will allow understanding of how consistent the response to LC106 is, and whether directly monitored administration improves results.",[19],"Bacterial Vaginosis",[],"INTERVENTIONAL","TREATMENT",[24],"EARLY_PHASE1",{"count":26,"type":27},26,"ACTUAL",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","LC106","This is a 6-strain L. crispatus vaginal live biotherapeutic tablet",[34],"Re-challenge",[36],{"measure":37,"description":38,"timeFrame":39},"Rate of colonization with LBP isolates","Detection of at least one isolate from the LBP with at least 5% relative abundance by metagenomics, or a combination of isolates at 10% or higher.","5 weeks",[],"FEMALE","18 Years","40 Years",{"inclusion":45,"exclusion":48,"raw_text":52},[46,47],"Previous participant in the VIBRANT study, randomized to active LBP","Nugent score 4-10",[49,50,51],"Infection requiring antibiotics detected on screening labs","Use of oral or vaginal antibiotics in the 30 days prior to screening","Use of an oral or vaginal probiotic in the 30 days prior to screening","Inclusion Criteria:\n\n* Previous participant in the VIBRANT study, randomized to active LBP\n* Nugent score 4-10\n\nExclusion Criteria:\n\n* Infection requiring antibiotics detected on screening labs\n* Use of oral or vaginal antibiotics in the 30 days prior to screening\n* Use of an oral or vaginal probiotic in the 30 days prior to screening",[54],"ADULT",[56,65],{"facility":57,"city":58,"state":59,"zip":60,"country":61,"geoPoint":62},"Massachusetts General Hospital","Boston","Massachusetts","02114","United States",{"lat":63,"lon":64},42.35843,-71.05977,{"facility":66,"city":67,"country":68},"CAPRISA","Vulindlela","South Africa",[],[71,74],{"name":72,"affiliation":57,"role":73},"Caroline M Mitchell, MD, MPH","PRINCIPAL_INVESTIGATOR",{"name":75,"affiliation":76,"role":73},"Disebo Potloane, MD","Centre for the AIDS Programme of Research in South Africa",[],[],{"nct_id":4,"conditions":80,"biomarkers":81},[19],[],{"nct_id":4,"found":83,"summary":84,"prompt_version":94},true,{"design":85,"status":86,"heading":87,"summary":88,"follow_up":89,"word_count":90,"commitments":91,"compensation":92,"drugs_mentioned":93},"This is an open-label (you and the researchers know what treatment you receive), single-arm (everyone gets the same treatment) study involving about 71 participants.","completed","LC106 for Bacterial Vaginosis","This study is testing a vaginal live biotherapeutic tablet called LC106, which contains six strains of L. crispatus bacteria. It's for women aged 18 to 40 who have bacterial vaginosis (an imbalance of bacteria in the vagina) and previously participated in the VIBRANT study, receiving the active treatment. The main goal is to see how consistently LC106 helps healthy bacteria colonize the vagina. You cannot join if you have an infection needing antibiotics, or have used antibiotics or probiotics recently. The study aims to enroll 71 participants, but its current recruitment status is unclear.","The study measures colonization with LC106 isolates at 5 weeks.",94,"If your vaginal microbiome isn't Lactobacillus-predominant, you will receive LC106 in the clinic for three consecutive days.","Not stated in the trial record.",[31],"v2"]