Bacterial Vaginosis
Conditions
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.
Interventions
OTHERMetronidazole
Women with Bacterial Vaginosis treated with Metronidazole for 5 days
Healthy women without Bacterial Vaginosis
Sponsors
Community Pharmacology Services Ltd
Danisco
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United Kingdom
Outcome results
None listed