Effects of over-the-counter lactic acid-containing vaginal douching products on the vaginal microbiota

Women worldwide engage in different vaginal practices, like herbal steambaths,
herbal insertions into the vagina, or intra-vaginal douches and they have a
wide variety of reasons to do so. With intra-vaginal douching a douching device
is placed into the vagina to spray a liquid. This is a common practice among
women in Western countries. Moreover, these products are widely available and
advertised on TV even though the biologic effects of these products for vaginal
use, including the effects on the vaginal microbiota, have barely been studied
by independent researchers and are therefore not known.

Bacterial vaginosis (BV) is an imbalance of the microbial vaginal flora
characterised by a decrease of lactobacilli and an increase of other anaerobic
and/or facultative anaerobic bacteria.

The aim of our pilot intervention study is
1) to describe the effects of lactic acid-containing vaginal douching on the
vaginal microbiota dynamics using novel molecular laboratory methods.
2) to describe the effect of lactic acid-containing vaginal douching on the
change in BV status using validated clinical and microscopic criteria (Nugent
and Amsel scores).
The goal of our study is to improve the sexual and reproductive health of
women. Results will also contribute to public health recommendations regarding
the use of lactic acid-containing vaginal douching products.

Prospective pilot intervention study.
Women will self-collect vaginal swabs during three menstrual cycles. The first
cycle women will refrain from using any vaginal douche product. The second
cycle women will use the lactic acid-containing douching product 3 times a week
(eg, Monday, Wednesday, Friday) for 4 weeks. The third cycle women will again
refrain from using any vaginal douche product.

The over-the-counter available Etos® Intiem vaginale douche and Etos® Intiem
vloeistof.

All participants with vaginal infections will be offered treatment at the study
site according to the guidelines used by the STI clinic for the management of
sexually transmitted infections.

Participation in this study probably poses no risk. Indirectly, information
gained from this study may lead to increased knowledge about changes in vaginal
microbial composition after use of lactic acid-containing douching products,
and about risk factors for BV.

This study involves identification of microbiologic effects of lactic
acid-containing vaginal douching products. Health-related data can be used to
monitor the occurrence of vaginal infections in the female population. The
products used for the intervention are licensed as over the counter products
and the sample collection imposes no additional risk to the participants.