Bacterial vaginosis is considered the most common cause of vaginal infection among pregnant and non-pregnant women, with a prevalence between 4.9 and 36.0% (data reported by European and American studies).
In addition, about 75% of women of reproductive age have at least one episode of vulvovaginal candidiasis (VVC).
And about half of them, two or more relapses occur. The most common pathogen is Candida albicans, which is isolated in 85-90% of cases.
Asymptomatic colonization with Candida spp. is also common. It can be found in about one-third of women without symptoms and was identified in 70% during a one-year observation period.
The onset of these pathologies is linked to a common phenomenon: the alteration of the vaginal bacterial flora, also known as dysbiosis. It is a problem that can quickly occur in a woman’s life and that, often, common antibiotic treatments struggle to eliminate definitively.
The vagina is a complex environment colonized by a diverse community of microorganisms known as the vaginal microbiota.
Among these, Lactobacillus spp. Represents the predominant microorganism in a healthy vaginal ecosystem; its importance is given by the ability to produce lactic acid and promote the health of the vaginal epithelium, as well as to maintain the pH at physiological levels (about 4/4.5), thus hindering the invasion of external pathogens or the proliferation of pathobionts (potentially pathogenic commensal strains). Added to this is the production of bacteriocins and an important antimicrobial function.
Often alterations can occur in the composition of the vaginal ecosystem, and, specifically, an abnormal microbial variety with many pathogens may replace the normal vaginal flora dominated by lactobacilli. This generates a state of imbalance or, precisely, dysbiosis, which, as already mentioned, makes it easier for vaginal infections and other diseases such as bacterial vaginosis (BV) and aerobic vaginitis (AV), both associated with a significantly increased risk of preterm birth in case of pregnancy or vulvovaginal candidiasis (VVC).
For example, bacterial vaginosis is characterized by increased vaginal pH (typically ≥ 4.5), vaginal discharge, an unpleasant odour, and replacing vaginal lactobacilli with anaerobic bacteria. Women diagnosed with BV have up to 1,000 times more anaerobic bacteria than healthy women.
Aerobic vaginitis is instead defined according to specific conditions that include abundant odourless yellow discharge, increased vaginal pH (typically ≥ 5), inflammation with leukocyte infiltration (increase in the number of leukocytes), absence of lactobacillus flora and presence of predominant aerobic microbes.
The causes that can lead to vaginal dysbiosis can be numerous, as the balance of the ecosystem is very delicate. Specifically, hormonal alterations, sexual activity, phases of the menstrual cycle, the consumption of broad-spectrum antibiotics, too-aggressive intimate hygiene products and even stress and a decline in immune defences can be a reason for imbalance.
In general, antibiotic or antifungal treatments are used to treat diseases related to dysbiosis of the vaginal microbiota. Still, they are not always practical or, in any case, can lead to side effects such as the development of drug resistance that can lead to a greater possibility of recurrences that are difficult to cure.
In this scenario, the oral intake of probiotics with intestinal action is increasingly emerging as a valid option.
The Research and Development laboratories of Biofarma Group, which have always been active in developing products to support women’s health, have developed a formulation that can represent a valid aid in case of vaginal dysbiosis and associated diseases.
The active ingredients selected for the formulation are the probiotic strains L. acidophilus GLA-14 and L. rhamnosus HN001, and lactoferrin.
The choice of lactobacilli strains stems from the need to solve the problem of the inability of antibiotics to restore normal vaginal bacterial flora spontaneously. This can only be achieved through recolonization of the ecosystem by lactobacilli, which, as has already been pointed out, play the critical role of creating a barrier against pathogens.
This is why numerous studies have focused on the search for a solution or on the observation of the effects deriving from the integration of these microorganisms.
Specifically, a study observed the effects of the strains selected for this formulation, L. acidophilus GLA-14 and L. rhamnosus HN001, on four bacteria responsible for bacterial infections and recurrences. The results showed the ability of the lactobacilli combination to inhibit the growth of all pathogens tested.
Lactoferrin also has a substantial impact on microbiota growth and diversity as it can inhibit the development of a wide range of pathogenic bacteria and, at the same time, promote the growth of beneficial microorganisms, such as lactobacilli and bifidobacteria.
The synergistic action of L. acidophilus GLA-14, L. rhamnosus HN001 and lactoferrin is therefore combined in an innovative nutraceutical formulation with a proven and clinically studied mechanism of action to restore and maintain a healthy vaginal flora and promote the health of the genitourinary tract: Respecta®.
The product’s efficacy was tested in vitro in the first phase and in vivo in the second phase, which involved several trials performed on samples of healthy women and subjects suffering from vaginal infections.
Specifically, Respecta® was tested on a sample of 40 healthy women (full study) and 40 women with an intermediate imbalance of the vaginal flora (full study). In both cases, the ability of the components of the formulation to colonize the vaginal tract was observed, thus ensuring the maintenance of well-being.
The product was also tested on samples of women suffering from bacterial vaginosis and vulvovaginal candidiasis in two different trials. In both cases, the results showed the formulation’s ability to improve symptoms, increase the cure rate and lower the number of cases of recurrence of diseases.
The presence of tests carried out both on healthy women and on women with cases of vaginal dysbiosis, or even already related diseases, highlights a dual function of the product: both preventives aimed at maintaining the balance of bacterial flora and adjuvant action of the treatment of infections of the vaginal tract.
The recommended intake protocol involves the consumption, together with a glass of water, of one capsule twice a day for 5-7 days, preferably between meals, then continuing with the intake of one capsule a day for a further week, or according to the opinion of the attending physician. The product can also be taken during antibiotic therapy.
Finally, Respecta® is an innovative formulation that does not require refrigeration for storage. The capsules are, in fact, individually sealed in an aluminium blister that allows ensuring that the probiotics remain viable until the moment of intake and, above all, in sufficient quantities to achieve the therapeutic objectives.
Edited by:
Antonella Venuti: R&D Manager
Valentina Milite: R&D Food Supplement
Bibliography
Bertuccini L., Russo R., Iosi F., Superti F., “Effects of Lactobacillus rhamnosus and Lactobacillus acidophilus on bacterial vaginal pathogens”, International Journal of Immunopathology and Pharmacology 1–5
De Alberti D., Russo R., Terruzzi F., Nobile V., Ouwehand A. C., “Lactobacilli vaginal colonisation after oral consumption of Respecta® complex: a randomised controlled pilot study”, Archives of Gynecology and Obstetrics volume 292, pages 861–867 (2015)
Russo, R., Edu, A., & De Seta, F. (2018). Study on the effects of an oral lactobacilli and lactoferrin complex in women with intermediate vaginal microbiota. Archives of Gynecology and Obstetrics, 298(1), 139-145
Russo, R., Superti, F., Karadja, E., & Seta, F. D. (2019a). Randomised clinical trial in women with Recurrent Vulvovaginal Candidiasis: Efficacy of probiotics and lactoferrin as maintenance treatment. Mycoses, 62, 328–335.
Russo, R., Karadja, E., & Seta, F. D. (2019b). Evidence-based mixture containing Lactobacillus strains and lactoferrin to prevent recurrent bacterial vaginosis: a double blind, placebo controlled, randomised clinical trial. Beneficial Microbes, 10, 19–26
