Safety and Efficacy of an Intravaginal Prebiotic Gel in the Prevention of Recurrent Bacterial Vaginosis: A Randomized Double-Blind Study

Abstract

Objective. This study was performed to evaluate the efficacy and safety of a prebiotic treatment in the balance recovery of the vaginal flora in subjects previously treated for bacterial vaginosis (BV). Study Design. A randomized trial was carried out on 42 subjects with an active prebiotic group compared to a placebo group. The main evaluation criterion was the quantification of the vaginal flora measured by the Nugent score. Secondary criteria included vaginal pH and BV recurrence. Results. After 8 days of treatment, all subjects who received the prebiotic had a normal Nugent score, whereas 33% of the subjects treated with placebo had an intermediate or positive Nugent score. After 16 days of application, a normal Nugent score was maintained in all subjects treated with the prebiotic, whereas in the placebo group 24% of the subjects still had an elevated Nugent score. Moreover, the maintenance of (or reversion to) a normal flora was associated with the maintenance of (or reversion to) physiological pH values. Conclusions. The intravaginal gel treatment improves the recovery of a normal vaginal flora after the treatment of a BV episode, which should warrant a reduction in the risk of further recurrences.

The vaginal microbiota, human papillomavirus infection and cervical intraepithelial neoplasia: what do we know and where are we going next?

“…FOS and GOS have been shown to promote the growth of L. crispatus , L. jensenii and L. vaginalis in vitro but not Candida albicans , Escherichia coli or G. vaginalis , with the investigators using high-performance liquid chromatography (HPLC) to show that GOS and FOS could not be used as energy sources by the three latter pathobionts [121]. GOS, applied as an intravaginal gel, has been shown in a randomised controlled trial of 42 women, immediately following metronidazole treatment for BV, to result in a significant reduction in Nugent scores at 8 and 16 days of treatment [122]. Konjac glucomannan hydrolysates (GMH) have similarly been shown to promote Lactobacilli spp.…”

Probiotics and prebiotics potential for the care of skin, female urogenital tract, and respiratory tract

“…Finally, the product was well tolerated and accepted. Coste et al (2012) evaluated the efficacy and safety of an intravaginal prebiotic gel in the balance recovery of the vaginal flora in women previously treated for BV. The doubleblind, parallel placebo-controlled, randomized clinical trial included 42 premenopausal, nonpregnant women aged 18-50 years.…”

Gynecological Health and Probiotics

“…This intravaginal treatment proved to enhance the repopulation of a normal vaginal microbiota after the BV treatment (Coste et al, 2012). In this clinical trial, 42 women received the active APP-14 gel with the glucooligosaccharide alpha prebiotic and trifolium pretense extract, for 16 days.…”

“…The actual definition of probiotic is a "live microorganism which when administered in adequate amounts, confers a health benefit on the host" (FAO/WHO, 2002), which does not indicate that microorganisms have to be orally ingested, but could be also vaginally administered. Another way to impact the genital microbiota is to provide nutrients such as prebiotics that stimulate the growth of lactobacilli to the detriment of pathogens (Coste et al, 2012). Another way to impact the genital microbiota is to provide nutrients such as prebiotics that stimulate the growth of lactobacilli to the detriment of pathogens (Coste et al, 2012).…”