Prefem BV Infection treated with metronidazole
Research type
Research Study
Full title
PreFem: “What happens to the vaginal microbiota when a BV infection is treated with metronidazole?”
IRAS ID
226222
Contact name
Arthur Quwehand
Contact email
Sponsor organisation
Danisco Sweeteners Oy
Duration of Study in the UK
0 years, 6 months, 10 days
Research summary
This is a methodology study to confirm certain aspects of a future study planned to assess the efficacy of a probiotic in the prevention of recurrent BV. The main objectives for validity are:
-The time required for the vaginal microbiota (particularly Lactobacillus count) to return to normal after treatment of BV infection with metronidazole. This will assist in timing the start of probiotic treatment in the Pivotal study.
-The time required for the Nugent Score to return to normal after treatment of BV infection with metronidazole which will assist in timing the start of probiotic treatment in the Pivotal study.
- Recruitment methodology effectiveness
- The usefulness of the “Canestest” test as a screening tool
- The reliability of vaginal self swabbing by participants.REC name
East of Scotland Research Ethics Service REC 2
REC reference
17/ES/0072
Date of REC Opinion
12 Jul 2017
REC opinion
Further Information Favourable Opinion