PreFem: "What Happens to the Vaginal Microbiota When a BV Infection is Treated With Metronidazole?"

This method validation study will endeavour to obtain evidence for:

* Recruitment methodology effectiveness
* The usefulness of the "Canestest" test as a screening tool
* The time required for the vaginal microbiota (particularly Lactobacillus count) to return to normal after treatment of BV infection with metronidazole.
* The time required for the Nugent Score to return to normal after treatment of BV infection with metronidazole.

• Metronidazole (Other): Women with Bacterial Vaginosis treated with Metronidazole for 5 days
• Control: no treatment (Other): Healthy women without Bacterial Vaginosis

Primary outcomes

• Change in vaginal microbiota assessed with sequencing [Baseline, at day 8, and at day 15]: Change in vaginal microbiota is assessed with sequencing at 3 time points (baseline, at day 8 and at day 15 time points post antibiotic treatment.)

Secondary outcomes

• Vaginal microbiota/lactobacilli levels with Nugent scoring [Baseline, at day 8, and at day 15]: Nugent scoring is used for the evaluation of the vaginal microbiota at baseline, at 8 and 15 day time points post antibiotic treatment.
• Diagnosis of BV with "Canestest" [Baseline]: "Canestest" will be used to diagnose BV infection at baseline.

Sex: Female, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

* Signed informed consent
* Female gender
* Over 18 years of age
* Have a high probability for compliance with and completion of the study

Exclusion Criteria:

* Hypersensitivity to metronidazole --only applies to Group 2.
* Post-menopausal defined as at least 12 consecutive months without menstruation
* Treatment of BV in last 4 weeks
* Clinically significant menstrual irregularities
* Suspected presence of STDs or other vaginal infection
* Pregnancy
* Breast feeding
* Participation in other clinical studies which could influence genitourinary tract microbiota
* Substance abuse
* Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study

• Gordon Crawford, MD, Principal investigator, CPS Research