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NCT04046900 · ClinicalTrials.gov registry record · Phase 1
Vaginal Microbiota Transplant
A Phase 1 study of Recurrent Bacterial Vaginosis, sponsored by Douglas Kwon.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 62
- Enrollment target
- 1
- Study location
NCT04046900: Recruiting Phase 1 study of Recurrent Bacterial Vaginosis, sponsored by Douglas Kwon.
NCT04046900 is a Phase 1 study of Recurrent Bacterial Vaginosis that is actively recruiting participants, run by Douglas Kwon. The registered enrollment target is 62 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04046900, a Phase 1 study of Recurrent Bacterial Vaginosis, is actively recruiting participants, sponsored by Douglas Kwon.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 62 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized trial of vaginal microbiome transplant vs. saline placebo to restore a Lactobacillus dominant vaginal microbial community in women with recurrent bacterial vaginosis.
Primary Outcome
Lactobacillus crispatus dominant = relative abundance of Lactobacillus crispatus in the vaginal microbial community \> 50%
Conditions Studied
Interventions
- BIOLOGICAL Vaginal microbiome transplant
- DRUG Oral Metronidazole
- OTHER Sterile saline
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2021-04-22 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 1 |
What NCT04046900 shows while recruiting
NCT04046900 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 1 condition, with Recurrent Bacterial Vaginosis appearing as the primary indexed condition, and to 3 interventions - of which Vaginal microbiome transplant is the first listed.
NCT04046900 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04046900 about?
NCT04046900 is a clinical study titled "Vaginal Microbiota Transplant". This is a randomized trial of vaginal microbiome transplant vs. saline placebo to restore a Lactobacillus dominant vaginal microbial community in women with recurrent bacterial vaginosis.
What is the current status of trial NCT04046900?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2021-04-22. Estimated completion is 2026-09-30.
What conditions does trial NCT04046900 study?
This clinical trial studies the following conditions: Recurrent Bacterial Vaginosis.
What interventions are being tested in trial NCT04046900?
The interventions under investigation include: Vaginal microbiome transplant (BIOLOGICAL), Oral Metronidazole (DRUG), Sterile saline (OTHER).
Who is sponsoring clinical trial NCT04046900?
This trial is sponsored by Douglas Kwon, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04046900 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04046900's enrollment target sits among peer trials
62 824th of 2000 higher than 1,173 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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