Vaginal transplant to restore Lactobacillus-dominant vaginal communities
Vaginal microbiota transplant to promote Lactobacillus-dominant cervicovaginal communities
This trial tests whether placing healthy donor vaginal bacteria into people with recurrent bacterial vaginosis helps restore Lactobacillus-dominant vaginal communities.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Massachusetts General Hospital NIH-funded |
| Lab location | 1 site (Boston, United States) |
| Project ID | NIH-11168678 on NIH RePORTER |
What this research studies
You would take a week of oral metronidazole and then be randomly assigned to receive either a vaginal microbiota transplant (VMT) from a carefully screened donor or a saline placebo, given as two doses in one week. Donors and the transplant material are screened and deeply characterized, and researchers will sequence and monitor the bacteria in donors and recipients over time to see if Lactobacillus becomes dominant and stable. The study plans to enroll about 126 recipients with recurrent BV and up to 25 healthy donors, with regular clinic visits and laboratory testing. Safety, symptom changes, and microbiome engraftment will be followed during the study period.
Who could benefit from this research
Good fit: Ideal candidates are people with a history of recurrent bacterial vaginosis and an abnormal Nugent score who can take oral metronidazole and attend follow-up visits.
Not a fit: People without recurrent BV, those who are pregnant, unable to take metronidazole, or severely immunocompromised are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, this approach could provide a longer-lasting treatment for recurrent bacterial vaginosis and reduce risks linked to a non-Lactobacillus vaginal microbiome, such as preterm birth and certain infections.
How similar studies have performed: Small pilot studies and case reports have shown promising results for VMT restoring Lactobacillus in some participants, but randomized controlled evidence is still limited.
Where this research is happening
Boston, United States
- Massachusetts General Hospital — Boston, United States (Active)
Researchers
- Principal investigator: Mitchell, Caroline M — Massachusetts General Hospital
- Study coordinator: Mitchell, Caroline M
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.