ProFem: Bacterial Vaginosis infection in at-risk women

• Research type

  Research Study

• Full title

  ProFem: Effect of an oral probiotic blend on risk of bacterial vaginosis (BV) infection in at-risk women

• IRAS ID

  213237

• Contact name

  Arthur Quwehand

• Contact email

  arthur.ouwehand@dupont.com

• Sponsor organisation

  Danisco Sweeteners Oy

• Eudract number

  2016-003159-31

• Duration of Study in the UK

  1 years, 5 months, 17 days

• Research summary

  Bacterial vaginosis (BV) is one of the most common causes of genital discomfort in women of reproductive age. The prevalence of BV varies in different parts of the world and is higher in developing countries.

  Current guidelines for treatment of BV specify the use of metronidazole or clindamycin administered orally or intra-vaginally. Up to 10% to 15% of patients, however, fail to respond to initial antimicrobial therapy and recurrence rates over time remain significant, reaching up to 80% and necessitating repeated administration of antibiotics.

  The main purpose of this study is to assess the effectiveness of an orally administered probiotic blend compared to placebo (a dummy capsule) on the incidence of Bacterial Vaginosis(BV)among “at risk” women defined as women with at least one clinically diagnosed episode of BV in the past and two BV episodes within the last 12 months.

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  16/ES/0111

• Date of REC Opinion

  5 Oct 2016

• REC opinion

  Further Information Favourable Opinion