Vaginal Microbiome Transplant in Asymptomatic Healthy Volunteers, Who Have Undergone Vaginal Microbiome Screening - a Randomised, Double-blind, Placebo-controlled Three-arm Study
Vaginal Microbiome Transplant in Asymptomatic Healthy Volunteers, Who Have Undergone Vaginal Microbiome Screening - a Randomised, Double-blind, Placebo-controlled Three-arm Study
This study will explore and map the potential shifts in vaginal microbiomes as a consequence of a microbial intervention with product FB101 in healthy, asymptomatic volunteer women screened to have vaginal dysbiosis based on criteria defined by quantitative polymerase chain reaction (qPCR) analysis of a vaginal swab sample.
This study will explore and map the potential shifts in vaginal microbiomes as a consequence of a microbial intervention with product FB101 in healthy, asymptomatic volunteer women screened to have vaginal dysbiosis based on criteria defined by qPCR analysis of a vaginal swab sample. A dose of FB101 will be given on 2 different days and subjects will be followed for changes in their vaginal microbiomes until approximately 3 months after the first FB101 dose. Two different dilutions will be tested of FB101 in 2 different active arms. The study will also have a third arm receiving placebo product. In addition, an antiseptic vaginal wash will be performed before the first dose of FB101/placebo in all 3 study arms. Randomisation ratios will be 1:1:1.
The study includes a screening visit where all criteria for participation are checked and a vaginal swab is obtained to check if pre-defined dysbiosis criteria are met based on qPCR analysis of key vaginal bacterial species. If, and when, all criteria are confirmed, a baseline visit is scheduled to be performed around day 14 in the same menstrual cycle of each individual subject. Besides baseline assessments, the subject is randomised to active FB101 or placebo in a ratio of 1(active, FB101):1(active, diluted FB101): 1(placebo) and the first dose is given. At visit 3 (performed the day after baseline visit the following dose is given.
In total, 5 follow-up visits are scheduled to occur for a period of up to 3 months after the first dose. All follow-up visits will be scheduled to occur around day 14 in the subject's menstrual cycle with one menstrual cycle in between visits. At follow up visits, close safety monitoring will be performed as well as metagenomic sequencing assessment of the microbiota in a vaginal swab.
Inclusion Criteria:
Be able and willing to give written informed consent.
Age between ≥18 to ≤45.
Be generally healthy, as determined by the investigator.
Be a pre-menopausal woman.
Meet the following definition of vaginal dysbiosis: combined copy number of Lactobacillus species crispatus, gasseri, and jensenii measured by qPCR, corresponding to less than 10% total relative abundance of Lactobacillus species crispatus, gasseri, and jensenii as measured by metagenomic sequencing.
Have regular, predictable menstrual cycles of known length or have been amenorrhoeic for at least 3 months due to use of a long-acting progestin or hormonal contraceptives.
Be willing to be asked questions about personal medical, sexual, and behavioural history.
Be willing to undergo two vaginal microbiome transplant procedures.
Be willing to self-collect cervicovaginal secretions and vaginal swab samples.
Be willing to use one of the following effective methods of contraception throughout the clinical study:
Be willing to completely abstain from vaginal intercourse and receptive oral sex during the eight days from visit 4 (first FB101 dose) to visit 6 (first follow-up).
Be willing to abstain from vaginal intercourse, unless using condoms free from adjunctive spermicide or lubricant (with a male partner) or dental dams (with a female partner), and receptive oral sex, unless using dental dams, in the time period between visit 3 and visit 8.
Be willing to avoid taking baths, swimming, or sitting in a hot tub in the time period between visit 3 and visit 8.
Be willing to abstain from using insertive vaginal feminine products (i.e., tampons, menstrual cups), vaginal cleansing products, spermicides, lubricants, or other vaginal products not approved by the study investigators, and any penetration using fingers or sex toys into the vagina, in the time period between visit 3 and visit 8.
Exclusion Criteria: