| Eligibility |
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 intervention.
Exclusion Criteria:
- Participants who are post-menopausal, defined as more than 12 consecutive months of
amenorrhea without another known cause than use of long-acting progestin or hormonal
contraceptives.
- Participants who are pregnant, breastfeeding and/or have been pregnant within the last
two months.
- Participants currently of childbearing potential, but not using an effective method of
contraception, as outlined below:
- Complete abstinence from intercourse two weeks prior to the intervention,
throughout the clinical study, until the completion of follow-up procedures or
for two weeks following discontinuation of the study participation in cases where
participant discontinues the study prematurely. (Participants utilising this
method must agree to use an alternate method of contraception if they should
become sexually active and will be queried on whether they have been abstinent in
the preceding 2 weeks when they present to the clinic for the Final Visit).
- Has a male sexual partner who is surgically sterilised prior to the Screening
Visit and is the only male sexual partner for that participant.
- Use of acceptable method of contraception, such as a spermicide, mechanical
barrier (e.g., male condom, female diaphragm), or contraceptive pill. The
participant must be using this method for at least 1 week following the end of
the study.
- Use of any non-hormonal intrauterine device (IUD) or contraceptive implant with
published data showing that the highest expected failure rate is less than 1 %
per year. The participant must have the device inserted at least 3 months prior
to the first Screening Visit, throughout the study, and 2 weeks following the end
of the study.
- Women in same-sex relationships, or who are likely to engage in sexual relationships
with other females throughout the study.
- Participants who have HIV/AIDS or other immunodeficiency.
- Participants who test positive at screening for HIV, chlamydia, gonorrhoea, Mycoplasma
genitalium, and/or trichomonas vaginalis.
- Participants with a current vaginal candida infection, bacterial vaginosis or other
condition requiring treatment that by the opinion of the investigator contraindicates
participation in the current study.
- Participants may not be receiving treatment involving experimental drugs. If the
participant has been in a recent experimental study, these must have been completed
not less than 30 days prior to this study.
- Participants who have undergone some sort of procedure involving trauma to the cervix
within the last 2 months prior to screening (i.e., IUD removal, cervical cryotherapy,
or cervical laser treatment.
- Participants with any known condition requiring regular use of antibiotics, that would
suggest the participant is likely to require antibiotic treatment during the study.
- Systemic and/or vaginally applied antibiotic use within the last month prior to
screening.
- Participants with new (<3 months) use of long-acting hormonal treatments. Participant
may be enrolled if stable (>3 months) or existing therapy as determined by the
investigator.
- Participants with any social, medical, or psychiatric condition that in the opinion of
the investigator would make it unlikely for the participant to comply with the study
or would complicate interpretation of data from her participation.
- Participants with a history of drug or alcohol abuse that in the opinion of the
investigator would make it unlikely for the participant to comply with the study or
would complicate interpretation of data from her participation.
- Participants with a history of gynaecological cancers, gynaecological conditions, or
surgical gynaecological medical history, which, in the opinion of the investigator,
precludes participation.
- Participants with abnormal finding on screening exam, which, in the opinion of the
investigator, precludes participation.
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