Safety and Efficacy of Vaginal Microbiota Transplant (VMT) in Women With Bacterial Vaginosis (BV) (NCT03769688) | Clinical Trial Compass
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 range
18 Years – 45 Years
Sex
FEMALE
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Bacteria engraftment as assessed by ribosomal (rDNA) gene sequencing
. 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.
Exclusion criteria
. Any history of bacterial vaginosis, recurrent yeast infection, trichomoniasis, syphilis, human papilloma virus (HPV) including genital warts, high grade pap smear, herpes, pelvic inflammatory disease, recurrent urinary tract infection, mycoplasma.
. Testing positive for HIV, Hepatitis A/B/C, syphilis, Human T-lymphotrophic Virus (HTLV)-I/II, WNV, Epstein-Barr Virus (EBV), rubella, toxoplasma gondii, Herpes Simplex Virus (HSV)-1/2, yeast or bacteria that are considered pathogenic/abnormal and/or show antibiotic resistance, chlamydia, gonorrhea, mycoplasma genitalium, trichomonas vaginalis, HPV.
. Cervicovaginal secretions (CVS) not dominated by one of the common vaginal lactobacillus species, as determined by qPCR.
. Currently pregnant or breastfeeding.
. History of gonorrhea or chlamydia within 12 months prior to screening.
. Travel or sexual partner travel to regions or countries where Ebola or Zika outbreaks occurred in the past 12 months.
. Any other medical, travel, or behavioral history that deems donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps) ineligible.
. HIV/AIDS or other immunodeficiency, or testing out of the range of normal clinical parameters for general measures of immunocompetence.