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

Danisco

Status

Completed

Conditions

Bacterial Vaginosis

Treatments

Other: Metronidazole

Other: Control: no treatment

Study type

Interventional

Funder types

Other

Industry

Identifiers

NH-03708

Details and patient eligibility

About

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

Full description

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.

Enrollment

60 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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