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

Study Overview
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Brief Summary
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The study will assess vaginal microbiota levels before and after antibiotic treatment in females infected with Bacterial Vaginosis (BV).

Detailed Description
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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.

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

Conditions
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Bacterial Vaginosis

Intervention / Treatment
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* Other: Metronidazole
* Other: Control: no treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment group<br>Metronidazole 400 mg 3 times daily for 5 days for Bacterial Vaginosis (BV) infection | Other: Metronidazole<br>* Women with Bacterial Vaginosis treated with Metronidazole for 5 days<br>|
| Other: Control group<br>Healthy women without Bacterial Vaginosis and without treatment | Other: Control: no treatment<br>* Healthy women without Bacterial Vaginosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in vaginal microbiota assessed with sequencing | 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.) | Baseline, at day 8, and at day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal microbiota/lactobacilli levels with Nugent scoring | Nugent scoring is used for the evaluation of the vaginal microbiota at baseline, at 8 and 15 day time points post antibiotic treatment. | Baseline, at day 8, and at day 15 | 
| Diagnosis of BV with Canestest | Canestest will be used to diagnose BV infection at baseline. | Baseline |