A novel prebiotic approach for the treatment of bacterial vaginosis
Research type
Research Study
Full title
Evaluating a novel prebiotic approach for the treatment of bacterial vaginosis in advance of Clinical Trial Approval.
IRAS ID
196499
Contact name
Alastair Sutcliffe
Contact email
Sponsor organisation
Institute of child Health, University College London
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
What is the role of novel prebiotics in the treatment of bacterial vaginosis in women?
Bacterial vaginosis (BV) is a common chronic disease affecting the daily quality of life of women worldwide and has potentially devastating implications if it occurs in pregnancy. Dominance of the bacterium Lactobacillus is essential to maintaining vaginal health, but in BV the vaginal flora becomes over-populated with other bacteria or microbiota. Use of antibiotics to treat other infections may, in part, be a contributing factor that causes BV, whilst in contrast the use of antibiotics to treat BV has been shown to be largely ineffective. Prebiotics are substrates that promote growth of healthy vaginal microbiota. In particular, Lactobacillus are unique amongst species of the vaginal microbiota in using glycogen as a carbon source and it is recognised that glycogen derived from vaginal cells is reduced in BV. Furthermore, the use of prebiotics to treat BV has never been attempted. In the future, it is hoped that by treating BV, ascending vaginal infection can be prevented and a reduction in the risk of infection-associated premature birth might be achieved.
The aim of this project is to design a pessary containing glycogen with the objective that this carbon source will encourage the growth of residual Lactobacillus, restoring the species balance in vaginal microbiota of BV patients. In this study, 50 patients will be recruited from the Genito Urinary (GU) Marlborough clinic at the Royal Free Hospital, London, which sees around 3 walk-in BV cases per day. Two vaginal swabs will be taken from opposite sides of the vagina from each patient and cultured in the lab. The total duration of the study is 6 months, of which 3 months will be allocated to patient recruitment and obtaining samples.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
16/LO/0941
Date of REC Opinion
13 Jun 2016
REC opinion
Favourable Opinion