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

Danisco60 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Bacterial Vaginosis

Interventions

MetronidazoleOTHER

Women with Bacterial Vaginosis treated with Metronidazole for 5 days

Control: no treatmentOTHER

Healthy women without Bacterial Vaginosis

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

CPS Research

Glasgow, United Kingdom

Outcomes

Primary Outcomes

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.)

Time frame: Baseline, at day 8, and at day 15

Secondary Outcomes

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.

Time frame: Baseline, at day 8, and at day 15

Diagnosis of BV with "Canestest"

"Canestest" will be used to diagnose BV infection at baseline.

Time frame: Baseline

Data from ClinicalTrials.gov

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