NCT03187457

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Danisco · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bacterial Vaginosis

Interventions

Type	Name	Description
OTHER	Metronidazole	Women with Bacterial Vaginosis treated with Metronidazole for 5 days
OTHER	Control: no treatment	Healthy women without Bacterial Vaginosis

Timeline

• Start date: 2017-09-04
• Primary completion: 2017-11-14
• Completion: 2017-11-14
• First posted: 2017-06-15
• Last updated: 2017-12-13

Locations

1 site across 1 country: United Kingdom