FB101 Intervention in Women Screened to Have Vaginal Dysbiosis (Dyscover-3) (NCT05850078) | Clinical Trial Compass
CompletedNot Applicable
FB101 Intervention in Women Screened to Have Vaginal Dysbiosis (Dyscover-3)
Ireland97 participantsStarted 2023-05-18
Plain-language summary
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.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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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:
* Complete abstinence from vaginal intercourse.
* Have a male sexual partner who is surgically sterilised prior to the screening visit and is the only male sexual partner for that participant.
* Mechanical barrier (condom or diaphragm), or hormone contraception (contraceptive pill, injections, implant or patch).
* 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 foll…
What they're measuring
1
Changes in relative abundance of vaginal lactobacilli species
Timeframe: from baseline to 2 months after first dose