drugset / Trial / NCT03769688

Safety and Efficacy of Vaginal Microbiota Transplant (VMT) in Women With Bacterial Vaginosis (BV)

NCT03769688 ↗

Phase 1 Withdrawn Johns Hopkins University
RandomizedParallel-groupDouble-blindBasic science

Summary

The composition of a woman's vaginal microbiota has a significant impact on her reproductive tract health and general quality of life. Approximately one-third of all women currently have bacterial vaginosis (BV), a polymicrobial condition in which the vaginal microbiota is not dominated by Lactobacillus species, leading to increased risk of various reproductive tract maladies and negative impact on well-being. It has been suggested by epidemiological studies that vaginal microbiota are readily transferable from one woman to another. Here, investigators aim to explore the hypothesis that vaginal microbiota can be engrafted from one woman to another in a controlled clinical setting by using cervicovaginal secretions (CVS), a process referred to as vaginal microbiota transplant (VMT).

Timeline

Start
2022-03
Primary completion
2023-12
Completion
2023-12

Outcome

Outcome not reported

Stopped: “Replaced with different study at another site.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Cervicovaginal secretions Other / unclassified 10 mg Other
Background Metronidazole gel Unknown — Other

Indications