Vaginal transplant to restore Lactobacillus-dominant vaginal communities
Official title: Vaginal microbiota transplant to promote Lactobacillus-dominant cervicovaginal communities
Funded at Massachusetts General Hospital · NIH-11168678 · Data updated 2026-11-12
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 start | September 20, 2021 |
| Project end | August 31, 2027 |
| Funding year | 2025 |
| Award (this year) | $832,912 |
| NIH project number | 5R01AI158836-04 |
| Project ID | NIH-11168678 on NIH RePORTER |
Who could benefit from this research
✓Could help
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.
✕Less likely to help
People without recurrent BV, those who are pregnant, unable to take metronidazole, or severely immunocompromised are unlikely to benefit from this trial.
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.
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 gone: 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
-
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.
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Vaginal microbiota transplant to promote Lactobacillus-dominant cervicovaginal communities
A clinical trial tests whether transferring vaginal microbiota from healthy donors can establish Lactobacillus-dominant vaginal communities to reduce risks linked with bacterial vaginosis.
-
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.
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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.
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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.
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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.
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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.
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.