FB101 Intervention in Women Screened to Have Vaginal Dysbiosis (Dyscover-3)

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.
• •Users of any hormonal or non-hormonal intrauterine device (IUD).
• •Participants who have HIV/AIDS or other immunodeficiency.
• •Participants who test positive at screening for HIV, chlamydia, gonorrhoea, Mycoplasma genitalium, and/or Trichomonas vaginalis. Potential participants may be re-screened if they receive successful treatment at their own medical provider.
• •Participants who have received treatment involving experimental drugs less than 30 days prior to this study.
• •Participants who have undergone some sort of procedure involving trauma to the cervix within the last month 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 examination, which, in the opinion of the investigator, precludes participation.
• •Participants with clinically relevant abnormalities in the cervix or uterine cavity that could interfere with the collection of endometrial fluid.
• •Participants with history of hypersensitivity/allergic reactions to the antiseptic active component or its ingredients.
• •Participants who have previously received FB101 as part of a clinical study.