PreFem: "What Happens to the Vaginal Microbiota When a BV Infection is Treated With Metronidazole?"
- Conditions
- Bacterial Vaginosis
- Interventions
- Other: Metronidazole
- Registration Number
- NCT03187457
- Lead Sponsor
- Danisco
- Brief Summary
The study will assess vaginal microbiota levels before and after antibiotic treatment in females infected with Bacterial Vaginosis (BV).
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
- Signed informed consent
- Female gender
- Over 18 years of age
- Have a high probability for compliance with and completion of the study
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment group Metronidazole Metronidazole 400 mg 3 times daily for 5 days for Bacterial Vaginosis (BV) infection
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
CPS Research
🇬🇧Glasgow, United Kingdom