NCT03769688

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

VMT-01: Safety and Efficacy of Vaginal Microbiota Transplant (VMT) in Women With Bacterial Vaginosis (BV)

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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).

Conditions

• Bacterial Vaginosis

Interventions

Type	Name	Description
DRUG	Cervicovaginal secretions	Same as arm descriptions
DRUG	Metronidazole gel	5 day course of vaginal MetroGel will be used prior to VMT intervention.
DIAGNOSTIC_TEST	Screening tests	Diagnostic testing for a broad range of infectious pathogens in blood, vaginal swab, and urine samples, for general immunocompetence, and for potential pregnancy.
BEHAVIORAL	Activities restriction	Required abstinence from sexual intercourse, usage of insertive vaginal feminine products (i.e. Tampons, menstrual cups, sex toys), other vaginal products (cleansing products, spermicides, lubricants, hygiene powders and sprays), and avoidance of behaviors including taking baths, going swimming, sitting in hot tub, or wearing thong underwear. Sanitary napkins are acceptable.
OTHER	Sterile Saline placebo	This will be administered as a placebo in place of cervicovaginal secretions

Timeline

• Start date: 2022-03-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2018-12-07
• Last updated: 2021-11-03

Regulatory

• FDA-regulated drug study