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NCT06135974 · ClinicalTrials.gov registry record · Early Phase 1
Vaginal lIve Biotherapeutic RANdomized Trial
A Early Phase 1 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 24
- Enrollment target
NCT06135974: Completed Early Phase 1 study, sponsored by Massachusetts General Hospital.
NCT06135974 is a Early Phase 1 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 24 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06135974, a Early Phase 1 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The goal of this randomized clinical trial is to evaluate safety and biologic effect of a multi-strain vaginal L. crispatus live biotherapeutic product (LBP) in people receiving antibiotic treatment for bacterial vaginosis (BV). The main question\[s\] it aims to answer are whether the intervention is safe, and whether the strains of L. crispatus will colonize recipients' vagina. The study will evaluate one LBP with 6 strains of L. crispatus (LC106) and one LBP with 15 strains (LC115) vs. placebo. Participants will: * be treated with oral antibiotics for BV * receive 7 days of vaginal study product * collect daily home swabs and make short daily diary entries for 5 weeks, including the week of antibiotic treatment and the week of study product treatment. Researchers will compare the 3 groups receiving different dosing strategies of LC106 and 1 group receiving LC115 vs. 1 group receiving placebo to see if the live biotherapeutic strains colonize the vagina after antibiotic treatment for BV.
Primary Outcome
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
Interventions
- DRUG Placebo
- DRUG Metronidazole Oral
- DRUG LC106
- DRUG LC115
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2024-02-01 |
| Est. Completion | 2025-02-18 |
| Phase | Early Phase 1 |
What the finished NCT06135974 record still lists
NCT06135974 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT06135974 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06135974 about?
NCT06135974 is a clinical study titled "Vaginal lIve Biotherapeutic RANdomized Trial". The goal of this randomized clinical trial is to evaluate safety and biologic effect of a multi-strain vaginal L. crispatus live biotherapeutic product (LBP) in people receiving antibiotic treatment for bacterial vaginosis (BV). The main question\[s\] it aims to answer are whether the intervention i...
What is the current status of trial NCT06135974?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 24 participants. The study started on 2024-02-01. Estimated completion is 2025-02-18.
What interventions are being tested in trial NCT06135974?
The interventions under investigation include: Placebo (DRUG), Metronidazole Oral (DRUG), LC106 (DRUG), LC115 (DRUG).
Who is sponsoring clinical trial NCT06135974?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06135974's enrollment target sits among peer trials
24 1037th of 2000 higher than 914 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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