Vaginal microbiota transplant to promote Lactobacillus-dominant cervicovaginal communities
Funded at Massachusetts General Hospital · NIH-11411247 · Data updated 2026-11-12
A clinical trial tests whether transferring vaginal microbiota from healthy donors can establish Lactobacillus-dominant vaginal communities to reduce risks linked with bacterial vaginosis.
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 start | September 20, 2021 |
| Project end | August 31, 2027 |
| Funding year | 2026 |
| Award (this year) | $832,912 |
| NIH project number | 5R01AI158836-05 |
| Project ID | NIH-11411247 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults with a history of recurrent BV and an abnormal Nugent score who are willing to participate in donor screening and a randomized transplant trial.
✕Less likely to help
Individuals without BV history or those not meeting eligibility criteria may not benefit from this specific transplant intervention.
What this research studies
This study will enroll up to 25 healthy donors and 126 recipients with a history of recurrent BV. After a short course of metronidazole, recipients are randomized to receive a vaginal microbiota transplant or a saline placebo in two doses within one week. The research includes extensive testing of donors, transplant material, and recipient microbiota to understand how the transplanted community engrafts and remains stable. The goal is to identify factors that promote lasting, healthy vaginal bacterial communities and reduce related health risks. Participants will be monitored for safety and changes in the vaginal microbiome over time.
Why it matters
Potential benefit: If successful, this approach could lead to a durable shift toward healthy, Lactobacillus-dominant vaginal microbiota and lower risk of BV-related complications.
How similar studies have gone: Preliminary data suggest stability of donated Lactobacillus in transplant material, supporting potential success for this strategy.
Where this research is happening
-
Massachusetts General Hospital
Boston, United States Active
Researchers
- Principal investigator: Mitchell, Caroline M — Massachusetts General Hospital
- Study coordinator: Mitchell, Caroline M
Related research
Other NIH-funded projects on the same topics.
-
Fecal transplant to help alcohol-related liver disease
A clinical trial will test whether a standardized oral fecal microbiota transplant (FMT) capsule can help people with alcohol-related liver disease drink less and feel mentally better.
-
National Fecal Microbiota Transplant (FMT) Registry
This registry collects health and safety information from people who receive fecal microbiota transplants or related live-microbe treatments to help patients with recurrent or severe C. difficile infection.
-
Gut Restore-PAH: Microbiota Transplant to Help Pulmonary Angiopathy
A small pilot study will test whether transplanting healthy gut bacteria, with antibiotics beforehand and fiber support, can help people with pulmonary arterial hypertension.
-
Microbiota Transplant Therapy to Prevent HE Recurrence in Veterans with Cirrhosis
A Phase 2B multi-center study tests using donor microbiota transplants to prevent hepatic encephalopathy from coming back in Veterans with cirrhosis.
-
Understanding how Fecal Microbiota Transplant helps with C. difficile infection
This project aims to discover how fecal microbiota transplant (FMT) works to prevent C. difficile infections from coming back in patients.
-
Vaginal transplant to restore Lactobacillus-dominant vaginal communities
This trial tests whether placing healthy donor vaginal bacteria into people with recurrent bacterial vaginosis helps restore Lactobacillus-dominant vaginal communities.
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.