FB101 Intervention in Women Screened to Have Vaginal Dysbiosis (NCT05114031) | Clinical Trial Compass
CompletedNot Applicable
FB101 Intervention in Women Screened to Have Vaginal Dysbiosis
Ireland34 participantsStarted 2021-10-20
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 metagenomic sequencing 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.
* Is generally healthy, as determined by the investigator.
* Free of self-reported vaginal symptoms.
* Pre-menopausal women.
* Meets the following pre-defined criteria of vaginal dysbiosis: Combined Lactobacilli relative abundance below 10 % AND combined relative abundance of Gardnerella + Atopobium + Prevotella above 20 % based on metagenomic sequencing of vaginal sample.
* Has regular, predictable menstrual cycles of known length OR has been amenorrhoeic for at least 3 months due to use of a long-acting progestin or hormonal contraceptives.
* Is willing to be asked questions about personal medical, sexual, and behavioural history.
* Is willing to self-collect cervicovaginal secretions and vaginal swab samples at the clinic.
* Is willing to abstain from vaginal intercourse, unless using condoms, without the use of adjunctive spermicide or lubricant for at least one menstrual cycle length (28 days) after the intervention.
* Is willing to avoid taking baths, swimming, sitting in a hot tub, or wearing thong underwear for at least one menstrual cycle length (28 days) after the intervention.
* Is willing 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 for at least 1 menstrual cycle length (28 days) after the i…
What they're measuring
1
Changes in relative abundance of combined vaginal lactobacilli species
Timeframe: Comparing baseline (visit 2) to the following time points: 1 (visit 6), 2 (Visit 7), 3 (Visit 8), 4 (Visit 9), 5 (Visit 10) and 6 (Visit 11) months after Baseline