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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Withdrawn
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03769688
Enrollment
0
Registered
2018-12-07
Start date
2022-03-31
Completion date
2023-12-31
Last updated
2021-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Vaginosis

Keywords

bacterial vaginosis, cervicovaginal secretions, vaginal microbiota

Brief 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).

Interventions

DRUGCervicovaginal secretions

Same as arm descriptions

5 day course of vaginal MetroGel will be used prior to VMT intervention.

DIAGNOSTIC_TESTScreening tests

Diagnostic testing for a broad range of infectious pathogens in blood, vaginal swab, and urine samples, for general immunocompetence, and for potential pregnancy.

BEHAVIORALActivities 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.

This will be administered as a placebo in place of cervicovaginal secretions

Sponsors

Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

Inclusion criteria that apply to potential Donor participants: 1. Capable of reading and writing English and voluntarily provide written informed consent to participate in the study and comply with all study procedures. 2. Generally healthy, pre-menopausal women age 18-45 years old. 3. Regular predictable menstrual cycles or amenorrheic for at least 3 months due to use of long-acting progestin or continuous use of oral contraceptives. 4. Free of vaginal symptoms, such as odor, discharge, or itching. 5. Willing to be asked questions about personal medical, sexual, and behavioral history. 6. Willing to self-collect cervicovaginal secretions and vaginal swab samples. 7. Agree to abstain from using insertive vaginal feminine products (i.e. Tampons, menstrual cups, sex toys), other vaginal products (cleansing products, spermicides, lubricants, hygiene powders and sprays), vaginal and anal intercourse, taking baths, going swimming, sitting in hot tub, or wearing thong underwear during the entire sample donation period (from screening to the final donation). Sanitary napkins are acceptable. Inclusion criteria that apply to potential Recipient participants: 1. Capable of reading and writing English and voluntarily provide written informed consent to participate in the study and comply with all study procedures. 2. Generally healthy, pre-menopausal women age 18-45 years old. 3. Experiences recurrent bacterial vaginosis (BV) (at least 3 diagnoses in their lifetime), and has received treatment for BV on at least 1 prior occasion in the past 5 years. 4. Currently needing treatment for vaginal symptoms clinically diagnosed as BV (\>= 3 Amsel criteria and confirmed in the laboratory by Nugent score \>= 4) and suitable for 0.75% metronidazole vaginal antibiotic treatment. 5. Regular predictable menstrual cycles or amenorrheic for at least 3 months due to use of long-acting progestin or continuous use of oral contraceptives. 6. Women who are not sterilized or who are not using an Intra-uterine Device (IUD) or form of hormonal contraception must agree to barrier contraception (i.e. Condoms, diaphragm) for heterosexual intercourse during the study. Counseling will be provided for use of barrier contraception without the use of adjunctive spermicide or lubricant. 7. Willing to be asked questions about personal medical, sexual, and behavioral history. 8. Willing to self-collect cervicovaginal secretions and vaginal swab samples. 9. Willing to undergo VMT procedure. 10. Agree to abstain from vaginal intercourse, unless using a condom, for at least the 28 days after the VMT procedure. Condoms will be provided. 11. Agree to avoid taking baths, swimming, sitting in a hot tub, or wearing thong underwear for at least the 28 days after the VMT procedure. 12. Agree to abstain from using insertive vaginal feminine products (i.e. Tampons, menstrual cups, sex toys), vaginal cleansing products, spermicides, lubricants, or other vaginal products not approved by the study investigators after the VMT procedure through visit 8 (\ 6 months). Sanitary napkins are acceptable.

Design outcomes

Primary

MeasureTime frameDescription
Bacteria engraftment as assessed by ribosomal (rDNA) gene sequencing28 daysDetection of Donor vaginal Lactobacillus in Recipient by 16S rDNA gene sequencing (\ 1% or greater relative abundance by read count)

Secondary

MeasureTime frameDescription
Bacteria engraftment as assessed by rDNA gene sequencing10 daysDetection of Donor vaginal Lactobacillus in Recipient by 16S rDNA gene sequencing (\ 1% or greater relative abundance by read count)
Bacterial communities as assessed by rDNA gene sequencingAt screening , and then follow-up (~7 months)Identify bacterial communities colonizing the vagina at screening in women with bacterial vaginosis and after antibiotic and CVS treatment by 16S rDNA sequencing
Bacterial vaginosis recurrence as assessed by Amsel's criteriaUp to 6 months after VMT procedureDetermination of recurrence of BV in participants by Amsel's criteria. Amsel's criteria includes the presence of a homogeneous vaginal discharge, pH of the vagina being \> 4.5, the presence of clue cells in gram stained vaginal discharge smears and a positive whiff test. According to Amsel, if 3 of the 4 criteria are positive, the patient has bacterial vaginosis
Bacterial vaginosis recurrence as assessed by Nugent scoreUp to 6 months after VMT procedureDetermination of recurrence of BV in participants by Nugent score. The Nugent score is calculated by assessing for the presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0 to 4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0 to 4), and curved Gram-variable rods (Mobiluncus spp. morphotypes; scored as 0 to 2). A total score of 7 to 10 is consistent with bacterial vaginosis without culture.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026