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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06135974
The ClinicalTrials.gov registry entry for NCT06135974 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT06135974 reports 0 study locations.
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.
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