WithdrawnPhase 1

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

Stopped: Replaced with different study at another site.

0Started 2022-03

Plain-language 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).

Who can participate

Age range18 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Capable of reading and writing English and voluntarily provide written informed consent to participate in the study and comply with all study procedures.
✓. Generally healthy, pre-menopausal women age 18-45 years old.
✓. Regular predictable menstrual cycles or amenorrheic for at least 3 months due to use of long-acting progestin or continuous use of oral contraceptives.
✓. Free of vaginal symptoms, such as odor, discharge, or itching.
✓. Willing to be asked questions about personal medical, sexual, and behavioral history.
✓. Willing to self-collect cervicovaginal secretions and vaginal swab samples.
✓. 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.
✓. Capable of reading and writing English and voluntarily provide written informed consent to participate in the study and comply with all study procedures.

What they're measuring

Bacteria engraftment as assessed by ribosomal (rDNA) gene sequencing

Timeframe: 28 days

Trial details

NCT IDNCT03769688

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12

View on ClinicalTrials.gov More Bacterial Vaginosis trials

Plain-language summary

Who can participate

Age range18 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Capable of reading and writing English and voluntarily provide written informed consent to participate in the study and comply with all study procedures.
✓. Generally healthy, pre-menopausal women age 18-45 years old.
✓. Regular predictable menstrual cycles or amenorrheic for at least 3 months due to use of long-acting progestin or continuous use of oral contraceptives.
✓. Free of vaginal symptoms, such as odor, discharge, or itching.
✓. Willing to be asked questions about personal medical, sexual, and behavioral history.
✓. Willing to self-collect cervicovaginal secretions and vaginal swab samples.
✓. 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.
✓. Capable of reading and writing English and voluntarily provide written informed consent to participate in the study and comply with all study procedures.

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

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Exclusion criteria