Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06135974 | Vaginal lIve Biotherapeutic RANdomized Trial | EARLY_PHASE1 | COMPLETED | 24 | — | — | Feb 1, 2024 | Feb 18, 2025 | Mar 25, 2025 | 2 | United States, South Africa |
Detection of any one strain from the LBP at 5% relative abundance or greater, or any combination of strains at 10% relative abundance or greater using shotgun metagenomic sequencing
Assessment of safety by comparing number and severity of adverse events
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Vaginal placebo tablet administered daily for 7 days starting after antibiotic treatment |
| LC106 7 days | EXPERIMENTAL | Vaginal live biotherapeutic product with 6 strains of L. crispatus, administered daily for 7 days after antibiotic treatment |
| LC106 3 days | EXPERIMENTAL | Vaginal live biotherapeutic product with 6 strains of L. crispatus, administered daily for 3 days after antibiotic treatment and packaged with 4 tablets of placebo to maintain masking (so a total of 7 tablets) |
| LC106 7 days, early start | EXPERIMENTAL | Vaginal live biotherapeutic product with 6 strains of L. crispatus, administered daily for 7 days starting on the 3rd day of antibiotic treatment |
| LC115 | EXPERIMENTAL | Vaginal live biotherapeutic product with 15 strains of L. crispatus, administered daily for 7 days after antibiotic treatment |
| Name | Type | Description |
|---|---|---|
| LC106 | DRUG | Tablet containing at least 2 x 10\^6 CFU/tablet, and comprised of 6 strains of Lactobacillus crispatus |
| LC115 | DRUG | Tablet containing at least 2 x 10\^6 CFU/tablet, and comprised of 15 strains of Lactobacillus crispatus |
| Placebo | DRUG | Vaginal tablets containing primarily microcrystalline cellulose and no live bacteria |
| Metronidazole Oral | DRUG | Metronidazole tablet orally twice daily for 7 days |
Inclusion Criteria: * Premenopausal individuals, 18- 40 years old * BV by Amsel criteria (at least 3 of 4 criteria must be present) * Abnormal Nugent score: ≥ 7 * Willing and able to provide written informed consent. * HIV uninfected (by HIV Ab/Ag test at enrollment) * Not pregnant by pregnancy tes...