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

    arthur.ouwehand@dupont.com

  • 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