Lactobacilli play a vital role in maintaining homeostasis in vaginal microbiota and there have been promising results not only for the treatment of dysbiosis, but also its onset in the first place.

A recent clinical trial has shown that, in as few as 10 days, consumption of the probiotic L. rhamnosus CA15 by mouth is able to reduce the severity and lower the extent of vaginal dysbiosis caused by candida overgrowth and bacterial infection.

Even after supplementation of probiotics has finished, beneficial effects continue for up to 30 days, maintaining vaginal eubiosis and averting the danger of relapse.

The CA15 probiotic promotes the balance of the vaginal microbiota, fostering the development of good bacteria to the detriment of other potentially dangerous microorganisms that could lead to fungal or bacterial vaginitis and vaginosis.

The beneficial effects of L. rhamnosus CA15

The clinical and preclinical findings of this trial point to the ability of the probiotic strain L. rhamnosus CA15 (DSM 33960), administered by mouth, to restore homeostasis in the vaginal microbiota and, therefore, to significantly reduce clinical signs and symptoms, improving the quality of life for women of reproductive age. 

More especially, the strain L. rhamnosus CA15 has been found to have interesting probiotic properties in vitro which make it capable of:

• inhibiting a broad spectrum of fungal and bacterial pathogens (Escherichia coli, Candida albicans, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis, Gardnerella vaginalis, Listeria monocytogenes, Pseudomonas aeruginosa, Pseudomonas monteilii, Staphylococcus aureus, Streptococcus agalactiae)
• inhibiting the formation of biofilms caused by species belonging to the Candida genus
• combating colonisation of the vaginal area by pathogenic bacteria, contributing to the maintenance and re-establishment of homeostasis of the vaginal microbiota
• producing large amounts of lactic acid which in turn lowers the vaginal pH
• exerting an anti-inflammatory action
• fighting off free radicals through its antioxidant action, thus reducing oxidative stress associated with the onset of various diseases.

The study

A randomised study with a double-blind control group was conducted in order to check the preclinical findings against in vivo results, and the effectiveness of CA15 administered by mouth was measured as a treatment for vaginal dysbiosis. 

The study was conducted in keeping with Good Clinical Practices and in accordance with the policies of the World Medical Association (WMA) on ethical standards for medical research on humans.

The clinical trial showed a statistically meaningful reduction in the signs and symptoms of vaginal dysbiosis (leukorrhea, a burning sensation, subjective perception of vaginal disorders, the presence of vulvovaginal erythaema/oedema and burning), as well as a reduction in the Amsel criteria (presence of clue cells, vaginal discharges, production of unpleasant smells and a vaginal pH greater than 4.5) and in the Nugent score.

These differences were detectable not only 10 days after the start of treatment, but also during the washout period (30 days after the treatment ended). No meaningful variations in the aforementioned signs and symptoms were encountered in the placebo group.

As far as the composition of the vaginal microbiota was concerned, as expected, all the patients when enlisted in the experiment had a low cell density of lactobacilli and a high number of vaginal pathogens, such as G. vaginalis, streptococci, enterococci and Candida spp. In other words, their microbial ecosystem was in a state of dysbiosis. Oral administration of the CA15 strain for 10 days resulted in a statistically meaningful reduction of the pathogenic microorganisms.

A statistical analysis of the data collected from the questionnaire about quality of life (WHOQOL-BREF) clearly showed that the patients who were administered CA15 experienced an improvement in physical health, social relations, sexual relations and in the overall quality of life. On the other hand, no meaningful variations were observed in the placebo group for any of the areas covered by the questionnaire.

For further information, download the full research paper beneath or visit the webpage about Sacco System probiotics for women’s health.

The following article is drawn from the feature “Aziende – Ingredienti e Prodotti” [Companies – Ingredients and Products] contained in issue 2017 (1) of the magazine “L’integratore nutrizionale” [Dietary supplement]. For the bibliography and to download the full article, click here.

The probiotic strain Lactobacillus rhamnosus has been used for many years in nutraceutical products, demonstrating various health benefits. Recently, it has been shown that administration of Lactobacillus rhamnosus during infancy can lead to a reduction in the incidence of tooth decay. 

Composition and technical specifications

Lactobacillus rhamnosus SP 1 is a probiotic strain owned by Sacco S.r.l., registered under DSM 21690, and identified through DNA sequencing coding for rRNA 16S with PCR testing. Typing of the strain was carried out through pulsed-field gel electrophoresis (PFGE). The GM-free bacterial strain is a gram-positive microaerophile and facultative heterofermentative. It is also free from gluten, soya and milk derivatives. As per EFSA indications, tests have been carried out that excluded the presence of acquired and potentially transmissible traits associated with resistance to antibiotics. The technical characteristics of Lactobacillus rhamnosus SP 1 are summarised in Table 1.

Efficacy and studies

Previous studies in Nordic countries have demonstrated an antagonistic action of Lactobacillus rhamnosus against cariogenic bacteria with consequent reduction in tooth decay in preschool children and a reduction in the risk of tooth decay (1–4).

A group of the Department of Dentistry at the University of Chile in Santiago went on to study the use of Lactobacillus rhamnosus SP 1 (produced by Sacco S.r.l.) and its effects on improvement in dental health in a group of children of preschool age (between two and three years) resident in Chile. No test of this type has previously been conducted in South America. The study carried out (5) involved 205 children attending 16 nursery schools included in the National Nutritional Programme of Santiago de Chile, with higher exposure to the risk of tooth decay. 123 children drank milk with Lactobacillus rhamnosus SP 1 and the other 82 children drank milk containing a placebo.

To participate in the study, children had to be healthy and without any intolerance to milk or other food allergies. The different schools that were part of the group that tested Lactobacillus rhamnosus SP 1 as a supplement and those in the control group were randomly selected. Neither the staff of the schools nor the families of the children or doctors were informed of which nursery schools would receive milk enriched with Lactobacillus rhamnosus SP 1 and which would receive the control milk without the probiotic. While attending the nursery schools on week days, children were given semi-skimmed milk produced with dissolved milk powder and therefore suited to the addition of Lactobacillus rhamnosus SP 1. In parallel, the placebo milk was also distributed, consumed in the same manner, as an afternoon snack (150 ml of milk). The milk was enriched with 1.5 billion live cultures using a freeze-dried culture of Lactobacillus rhamnosus SP1 in powdered form. The test period lasted 10 months and each day of school attendance a diary was filled out by the personnel of the 16 schools regarding the presence of children to guarantee adhesion to the study protocol.

The experimental design was that of a randomised, triple-blind, placebo-controlled parallel study. International ICDAS criteria were adopted for visual and tactile detection of tooth-decay lesions and to describe the severity of these lesions. Children were analysed at the start and end of the study by two dentists instructed by internal and external examiners in order to guarantee consistent and comparable results of the assessments.

Observations showed a slightly lower, yet in any case significant, presence of tooth decay in the group that had received Lb. rhamnosus SP 1 (54.4%) compared to the control group (65.8%). Another finding was that after two weeks without further administration of Lb. rhamnosus SP 1 (in total 12 months after the start of the test) tooth-decay lesions in children that had drunk milk with the addition of Lb. rhamnosus SP 1 were significantly lower (9.7%) compared to the control group (24.3%), demonstrating that the probability of dental lesions deriving from tooth decay during the period after administration of the bacteria was significantly reduced.

The mechanism of action may be linked to the fact that Lb. rhamnosus SP 1 interacts with the oral biofilm, changing its composition in favour of bacteria that produce fewer organic acids, enabling greater balance between the pH of saliva and that of plaque. In addition, this study highlighted a positive impact also after two months without further administration of probiotics. Other studies carried out with probiotic lactic acid bacteria have demonstrated that they were only temporarily present in the saliva, and therefore, a daily intake can be recommended to limit the appearance of tooth decay in children of preschool age. 
 

Safety

Lactobacillus rhamnosus SP 1 is a safe microorganism with QPS (Qualified Presumption of Safety) classification from the EFSA.

Application and methods of use

Lactobacillus rhamnosus SP 1 can be used as a probiotic supplement or added to probiotic food products. In accordance with Ministry of Health guidelines, the recommended total daily consumption of probiotics is 10⁹.

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Sacco System produces and markets a wide range of probiotics for dental and oral health.