The efficacy of probiotic b. Coagulans (snz-1969) tablets in the treatment of recurrent bacterial vaginosis

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Bacterial vaginosis (BV) is a common condition affecting 10–30% of women in developed nations. The current recommended treatment for BV is oral or vaginal antibiotics; however, recurrence rates of up to 60% within 12 months of treatment have been reported previously. The present study aimed to evaluate the efficacy of Bacillus coagulans (SNZ-1969) against BV and the ability of this bacterial species to prevent BV recurrence in women aged 18–41 years. The study assessed 173 women, and of these women, 120 showed recurrent BV according to Nugent’s and Amsel’s criteria. These 120 women were randomly assigned to the following study arms: metronidazole arm and metronidazole + B. coagulans arm. The metronidazole + B. coagulans arm showed better success (86.6%) in treating and minimizing recurrence of vaginal infections and consequently symptoms associated with BV, owing to the large number of lactobacilli administered in the B. coagulans arm. Oral supplementation with probiotics can be an efficient approach for the treatment of BV. Oral therapy for a longer duration would be more effective despite intestinal passage, vaginal ascension, and growth of lactobacilli requiring a long time. Long-term administration could probably allow controlled release of lactobacilli for preventing recurrence of BV.

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... The etiology of BV is not entirely clear. The reduction of hydrogen peroxide (H 2 O 2 )-producing Lactobacillus raises vaginal pH levels, causing G. vaginalis to greatly multiply [20][21][22]. Moreover, studies have shown that the mass reproduction of G. vaginalis is conducive to the growth of some biofilms, which in turn makes other anaerobes multiply in large numbers [23][24][25][26]. ...
... Despite numerous randomized controlled trials (RCTs) on probiotics in the treatment of BV, the efficacy of probiotics is still controversial. Some clinical trials have demonstrated that probiotics are beneficial to BV in adult women [20], but others dispute these claims [38,39]. To assess the influence of probiotics on the treatment of BV, we performed a systematic review and meta-analysis of RCTs to evaluate the therapeutic value of probiotics in BV patients. ...
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Background: The purpose of this meta-analysis was to assess the value of probiotics in the treatment of adult female bacterial vaginosis (BV). Methods: We looked for published randomized controlled trials in PubMed, Embase and The Cochrane Library from the inception dates of the database to January 3rd, 2022. We conducted the search focusing on the treatment of adult female BV with probiotics. Two independent researchers screened the literature, evaluated the trial quality and extracted the data according to the inclusion and exclusion criteria. The primary outcome was the ratio of patients with BV with recurrence according to Nugent score 7–10 for recurrence after treatment. After heterogeneity was assessed using Review Manager 5.4 software, meta-analysis and bias assessment were performed using Stata 17.0 software. Results: A total of 5 articles representing 425 patients were included in this meta-analysis. Compared with antibiotics alone or antibiotics combined with a placebo, probiotics or probiotics combined with antibiotics significantly reduced the rate of recurrence at around the 30th day (risk ratio (RR) 0.11; 95 % confidence interval (CI) 0.03–0.33). However, in the analysis of heterogeneity, we found that after 30 days, the therapeutic effect of probiotics decreased with the extension of follow-up time (RR 0.50; 95% CI 0.24–1.03), (RR 1.24; 95% CI 0.88–1.76). Conclusions: The short-term efficacy of probiotics in the treatment of BV in adult female patients may be satisfactory, but the long-term efficacy of probiotic therapy may be suboptimal and still requires validation by further clinical trials.
... In other clinical trial, for the treatment of bacterial vaginosis oral administration of Bacillus coagulans SNZ 1969 along with metronidazole for a period of 21 days showed better success, than metronidazole alone. Bacillus coagulans SNZ 1969 along with metronidazole minimized the recurrence of vaginal infections and consequent symptoms, such as vaginal discharge, malodor, burning micturition, and itching (Rani et al., 2017). In an open label fixed dose study, administration of oral Bacillus coagulans SNZ 1969 to patients with type II hyperlipidemia had shown hypolipidemic effects by reducing total serum cholesterol and LDL cholesterol and by increasing HDL cholesterol (Mohan et al., 1990). ...
Bacillus coagulans SNZ 1969 is a rod-shaped, slightly acidophilic, gram-positive, spore forming and highly resilient bacteria. B. coagulans SNZ 1969 has GRAS (Generally Recognized As Safe) status for use as a probiotic in foods (US FDA number GRN-597). The present study was aimed to assess the safety of a proprietary strain Bacillus coagulans SNZ 1969 by conducting acute and sub-acute 28 days repeated dose oral toxicity studies in Wistar Rats. In the acute toxicity study, the rats were orally fed with 2000 mg/kg body weight (BW) (5 × 1011 CFU/g) of B. coagulans SNZ 1969 as a single dose to determine the LD50 values. In the sub-acute repeated dose toxicity study, six groups of experimental rats received 250, 500, 1000 mg/kgBW/day (5 × 1011 CFU/g) of the test item for 28 consecutive days. The control animals received only water. Four groups of rats were sacrificed after 28 days and the remaining two groups were kept as recovery groups and sacrificed after 42 days. The results of these study indicate that there were no treatment related changes in any of the parameters studied i.e. clinical signs, body weight, food intake, urinalysis, hematological examinations, clinical biochemistry, gross pathology and histopathology after 28 days of repeated administration. Based on the results it was concluded that the LD50 of Bacillus coagulans SNZ 1969 is more than 2000 mg/kg body weight and the NOAEL derived from this study was 1000 mg/kg/day for 28 days, this corresponds to the 5 × 1011 CFU/kg.
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