Impact of Lactobacillus crispatus-containing oral and vaginal probiotics on vaginal health: a randomised double-blind placebo controlled clinical trial

Abstract

Health of reproductive tract is tightly associated with balance of microbial communities in this area. Bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC) represent common disturbances of vaginal communities. Vaginal discharge due to BV or VVC is a very frequent reason for visiting gynaecologist. We aimed to evaluate the impact of the novel evidence-based probiotics on BV and VVC patients. The study group included 89 BV and 93 VVC patients (aged 18-50 years) who were recruited into randomised double-blind placebo-controlled two-arm parallel trial. The patients of each diagnosis group received oral or vaginal probiotic capsules, or placebo capsules during 3 months. A probiotic capsule contained two (DSM32717 and DSM32720, in case of BV) or three (DSM32720, DSM32718 and DSM32716, in case of VVC) Lactobacillus crispatus strains. Vaginal, intestinal and general health was monitored weekly by questionnaire. Blood analyses were done in the beginning and at the end of trial. Vaginal samples were collected monthly, microscopic and molecular analyses were performed. The study revealed that both oral and vaginal capsules reduced the signs and symptoms in BV patients. Remarkable improvement was noted in Nugent score, amount and smell of discharge, but also in itching/irritation. Consumption of vaginal probiotics significantly increased the lactobacilli counts in their vagina while mean proportion of some BV-related bacteria decreased. In VVC patients, both oral and vaginal capsules lowered the combined score of two most important symptoms, amount of discharge and itching/irritation. In conclusion, the novel formulations of evidence-based well-focused probiotic L. crispatus strains are effective against BV and VVC being suitable for both vaginal and oral administration. Clinical trial registration: ISRCTN34840624, BioMed Central

Use of probiotic lactobacilli in the treatment of vaginal infections: In vitro and in vivo investigations

“…Therefore, ethnicity might be a key factor. Aside from these two well-known Lactobacillus strains, other strains such as L. acidophilus GLA-14, L. crispatus LMG S-29995, L. crispatus DSM32717, L. crispatus DSM32720, L. paracasei LPC-S01, and L. rhamnosus HN001 have also been used orally in clinical investigations ( Russo et al., 2019a ; Koirala et al., 2020 ; Reznichenko et al., 2020 ; Mändar et al., 2023 ). These trials revealed that oral probiotics can enhance the recovery rate and relieve the symptoms of BV, as well as improve the vaginal microbial profile.…”

“…These trials revealed that oral probiotics can enhance the recovery rate and relieve the symptoms of BV, as well as improve the vaginal microbial profile. As shown in Figure 2 , in addition to oral delivery, intravaginal administration is becoming increasingly popular among clinical studies ( Marcotte et al., 2019 ; Baldacci et al., 2020 ; Cohen et al., 2020 ; Armstrong et al., 2022 ; Mändar et al., 2023 ), possibly because intravaginal administration avoids the passage of lactobacilli into the highly acidic stomach, preventing loss of probiotics and accelerating the onset of effect. Compared to orally administered probiotics, which reach the vagina in approximately seven days, Lactobacillus strains administered intravaginally show effects in two to three days ( Mogha and Prajapati, 2016 ).…”

“…In a randomized, double-blind, placebo-controlled study, eight weeks of probiotic lactobacilli treatment was found to be helpful for pregnant women, particularly in its ability to relieve vulvovaginal symptoms and VVC recurrences, along with decreased emotional and social discomfort ( Ang et al., 2022 ). Similarly, oral or vaginal administration of three L. crispatus strains can lower the combined scores of two of the most important symptoms in VVC patients, the amount of discharge and the level of itching/irritation ( Mändar et al., 2023 ). In addition to lactobacilli alone, the combination of lactobacilli with antibiotics is also an effective therapy for vaginal Candida infection.…”

From the past to the future: Fermented milks and their health effects against human diseases

“…The mechanisms by which probiotics exert beneficial health effects can be summarized in three categories (Hill et al., 2014): Broad range of mechanisms commonly studied in probiotics. Examples: colonization resistance and competitive exclusion of pathogens (Mändar et al., 2023; Saracino et al., 2020; Stavropoulou & Bezirtzoglou, 2020), production of acids and short‐chain fatty acids (SCFAs) (Lim et al., 2023; Wang et al., 2023), regulation of intestinal transit and normalization of disturbed microbiota (Dahiya & Nigam, 2023b), and increased intestinal cell renewal (Gou et al., 2022; Hou et al., 2021; Tong et al., 2023). Mechanisms frequently observed in most probiotic strains.…”

“…Rare mechanisms present in only a few strains of a given species. Examples: those responsible for neurological (Dahiya & Nigam, 2023a), detoxification (Kariyawasam et al., 2021; Mahjoory et al., 2023), immunological and endocrine effects (Mändar et al., 2023), and the production of specific bioactive substances (Sun et al., 2023). …”