PreFem: "What Happens to the Vaginal Microbiota When a BV Infection is Treated With Metronidazole?" (PreFem)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03187457|
Recruitment Status : Completed
First Posted : June 15, 2017
Last Update Posted : December 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Bacterial Vaginosis||Other: Metronidazole Other: Control: no treatment||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||PreFem: "What Happens to the Vaginal Microbiota When a BV Infection is Treated With Metronidazole?"|
|Actual Study Start Date :||September 4, 2017|
|Actual Primary Completion Date :||November 14, 2017|
|Actual Study Completion Date :||November 14, 2017|
Metronidazole 400 mg 3 times daily for 5 days for Bacterial Vaginosis (BV) infection
Women with Bacterial Vaginosis treated with Metronidazole for 5 days
Healthy women without Bacterial Vaginosis and without treatment
Other: Control: no treatment
Healthy women without Bacterial Vaginosis
- Change in vaginal microbiota assessed with sequencing [ Time Frame: 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.)
- Vaginal microbiota/lactobacilli levels with Nugent scoring [ Time Frame: 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" [ Time Frame: Baseline ]"Canestest" will be used to diagnose BV infection at baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03187457
|Glasgow, United Kingdom, G20 0XA|
|Principal Investigator:||Gordon Crawford, MD||CPS Research|