Impact of Probiotic SYNBIO® Administered by Vaginal Suppositories in Promoting Vaginal Health of Apparently Healthy Women

Abstract

The purpose of this study was to investigate whether vaginal administration of probiotic Lactobacillus results in their colonization and persistence in the vagina and whether it promotes normalization and maintenance of pH and Nugent score. A single-arm, open-label controlled towards the baseline (pre-post) study including 35 apparently healthy women was conducted. Each woman was examined three times during the study. Women were instructed to receive daily for 7 days, the probiotic suppositories SYNBIO(®) gin (Lactobacillus rhamnosus IMC 501(®) and Lactobacillus paracasei IMC 502(®)). Vaginal swabs were collected during visit 1, 2, and 3 to determine the total lactobacilli count, the presence of the two administered bacteria, the measure of the pH, and the estimation of Nugent score. Evaluation of treatment tolerability was based on analysis of the type and occurrence of adverse events. The probiotic vaginal suppository was well tolerated and no side effects were reported. Intermediate Nugent score was registered in 40 % of women at visit 1 and these intermediate scores reverted to normal at day 7 (end of treatment) in 20 % of subjects. Administration of SYNBIO(®) gin contributed to a significant increase in the lactobacilli level at visit 2. Molecular typing revealed the presence of the two strains originating from SYNBIO(®) gin in 100 % of women at visit 2 and 34 % at visit 3. No significant changes were registered for pH between visits. The SYNBIO(®) gin product is safe for daily use in healthy women and it could be useful to restore and maintain a normal vaginal microbiota.

Lactobacilli‐containing vaginal probiotics to cure or prevent bacterial or fungal vaginal dysbiosis: a systematic review and recommendations for future trial designs

“…The search identified 2949 unique articles but only 34 studies were eligible (flow diagram in Figure ) . Thirteen studies reported 14 results on BV and/or molecular VMB composition (Table ), 12 studies reported 12 results on VVC (Table ), and 14 studies reported 15 results on vaginal probiotic strain detection using molecular techniques (Table S1). The selected studies evaluated 22 different vaginal probiotics (Table S2).…”

“…Thirteen studies reported 14 results on BV and/or molecular VMB composition (Table ), 12 studies reported 12 results on VVC (Table ), and 14 studies reported 15 results on vaginal probiotic strain detection using molecular techniques (Table S1). The selected studies evaluated 22 different vaginal probiotics (Table S2). The most studied were Gynoflor ( L. acidophilus KS400 plus 30 microgram oestriol; three studies with 359 participants), Lactin‐V ( L. crispatus CTV‐05; four studies with 132 participants), and L. reuteri RC‐14 with L. rhamnosus GR‐1 (four studies with 47 participants).…”

“…Most studies (11/13) were randomised controlled trials, including six with placebo controls, two with ‘no intervention’ controls, four with metronidazole or clindamycin controls, and one with a vaginal pH‐lowering tablet control (two trials included both placebo/‘no intervention’ and antibiotic controls) (Table ). Five clinical trials were judged medium risk and the other six high risk . The two remaining studies (both judged high risk) were pre‐post intervention studies in women receiving a vaginal probiotic without an antibiotic …”

The Role of the Cervicovaginal Microbiome on the Genesis and as a Biomarker of Premalignant Cervical Intraepithelial Neoplasia and Invasive Cervical Cancer

“…In this context, vaginal suppositories containing L. rhamnosus IMC 501 and L. paracasei IMC 502 were tested in apparently healthy women. The authors registered 40% of patients with an intermediate Nugent score before the treatment and half of them returned to a normal state (low Nugent score) after the intervention [132]. Besides, when compared to placebo, vaginal capsules of L. fermentum 57A, L. plantarum 57B and L. gasseri 57C were able to significantly reduce vaginal pH and Nugent score, suggesting a shift to a healthy vaginal microbiota profile.…”

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

“…The probiotic group had significantly lower incidence of discharge than metronidazole group (P = 0.024) and higher cure rate than metronidazole group, but this difference was not significant (P = 0.269). Verdenelli et al (2016) evaluated the effect of probiotic suppositories, SYNBIO® gin, on vaginal health. The study included 35 apparently healthy women (aged 18-48 years), who were instructed to receive daily for 7 days the probiotic suppositories SYNBIO® gin, containing at least 10 9 CFU of viable lactobacilli, a combination of L. rhamnosus IMC 501® and L. paracasei IMC 502®.…”