A clinical pilot study on the effect of the probiotic Lacticaseibacillus rhamnosus TOM 22.8 strain in women with vaginal dysbiosis

Pino, Alessandra; Rapisarda, Agnese Maria Chiara; Vitale, Salvatore Giovanni; Cianci, Stefano; Caggia, Cinzia; Randazzo, Cinzia Lucia; Cianci, Antonio

doi:10.1038/s41598-021-81931-z

Cited by 32 publications

(24 citation statements)

References 41 publications

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“…Nevertheless, the results should be interpreted cautiously as the number of studies included in the meta-regression analysis was rather limited ( k = 10). Similar to our results, a probiotic administration for a 10-day duration resulted in a significant reduction of pathogenic microbiota in vagina and the maintenance of vaginal eubiosis up to 30 days after the end of treatment, regardless of the route of administration ( 48 ). In contrast, a recent systematic review found that Lacticaseibacillus rhamnosus administered orally was more efficacious than intravaginal application for the treatment of BV ( 49 ), which was again likely to be due to unstandardized methodology mentioned above.…”

Section: Discussionsupporting

confidence: 90%

Probiotics, a promising therapy to reduce the recurrence of bacterial vaginosis in women? a systematic review and meta-analysis of randomized controlled trials

Chieng

Jalal²,

Bedi³

et al. 2022

Front. Nutr.

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IntroductionThe evidence for probiotic efficacy in preventing bacterial vaginosis (BV) recurrences among women aged 18 years and above is sparse. We aimed to ascertain the efficacy of probiotics in preventing BV recurrences after at least one menstrual cycle in this population.MethodsWe conducted a systematic literature search using PubMed, MEDLINE (Ovid interface), Web of Science (WoS), Scopus, Embase, ProQuest Dissertations and Theses Global, Cochrane Library databases and registries comprised of Open Science Framework (OSF) preprints registry, the ClinicalTrials.gov (USA), WHO International Clinical Trials Registry Platform (WHO-ICTRP), International Standard RCT Number (ISRCTN) registry, limited to randomized clinical trials (RCTs) in English published between January 2000 and December 2021. The inclusion criteria were trials that administered probiotics to BV-positive women in an experimental arm of at least 20 samples. The usage of probiotics should be preceded with standard antibiotic regimen and followed by a reassessment of BV status after at least a single menstrual cycle. Risk of bias assessment was completed using revised Cochrane risk-of-bias tool for randomized trials (RoB 2). The PROSPERO registration number of the review is CRD42022302044.ResultsFrom 8,162 identified records, we included 10 studies (n = 1,234 participants) for final analysis; 7 trials compared probiotics vs. placebo, whereas 3 trials compared probiotics vs. metronidazole alone. Using random-effects meta-analysis, probiotics were shown to reduce the risk of BV recurrences by 45% compared to either placebo or metronidazole [14.8 vs. 25.5%, RR: 0.55 (95%CI: 0.33, 0.91), p = 0.03, I2 = 45.4% (95%CI: 0, 73.7%)]. Sensitivity analysis revealed the robustness of results upon removal of studies with high risk of bias [RR: 0.54 (95%CI: 0.38, 0.77), p = 0.006] and reporting bias (RR: 0.53, 95%CI: 0.39, 0.74, p = 0.002). Meta-regression demonstrated that the route of administration (pvaginal = 0.67; poral = 0.44), the total dosage of probiotics (p = 0.17), cumulative days of probiotic administration (p = 0.76), and the number of species in probiotic preparation (p = 0.40) were not linked to BV recurrences.InterpretationProbiotics were associated with more than twofold reduction in BV recurrences when BV status was assessed after at least 1-month postintervention. Further high-quality and methodologically standardized RCTs should evaluate probiotic efficacy for BV prevention in a diverse community setting.Systematic review registration[https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021290613], identifier [CRD42021290613].

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Section: Discussionsupporting

confidence: 90%

Probiotics, a promising therapy to reduce the recurrence of bacterial vaginosis in women? a systematic review and meta-analysis of randomized controlled trials

Chieng

Jalal²,

Bedi³

et al. 2022

Front. Nutr.

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“…Hydrophobicity (H%), auto-aggregation (Auto-A%) and co-aggregation (Co%) abilities were tested as described by Pino et al (2021) [ 37 ]. Hydrophobicity was determined as bacterial adhesion to hydrocarbons (BATH) using xylene.…”

Section: Methodsmentioning

confidence: 99%

Characterization of Bifidobacterium asteroides Isolates

et al. 2022

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Bifidobacteria have long been recognized as bacteria with probiotic and therapeutic features. The aim of this work is to characterize the Bifidobacterium asteroides BA15 and BA17 strains, isolated from honeybee gut, to evaluate its safety for human use. An in-depth assessment was carried out on safety properties (antibiotic resistance profiling, β-hemolytic, DNase and gelatinase activities and virulence factor presence) and other properties (antimicrobial activity, auto-aggregation, co-aggregation and hydrophobicity). Based on phenotypic and genotypic characterization, both strains satisfied all the safety requirements. More specifically, genome analysis showed the absence of genes encoding for glycopeptide (vanA, vanB, vanC-1, vanC-2, vanD, vanE, vanG), resistance to tetracycline (tetM, tetL and tetO) and virulence genes (asa1, gelE, cylA, esp, hyl).

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“…A total of 71 presumptive G. vaginalis isolates (Supplementary Table 1) were recovered from the vagina of BV-positive patients enrolled at the Obstetrics and Gynecology Department, General Hospital G. Rodolico, University of Catania (Italy), and participated in a clinical trial approved by the local ethics committee (Comitato Etico Catania 1, Azienda Ospedaliero-Universitaria "Policlinico-Vittorio Emanuele" Catania, registration number 157/2019/PO; Pino et al, 2021). In detail, the vaginal…”

Section: Isolation and Identification Of Clinical Isolatesmentioning

confidence: 99%

Antimicrobial activity of bovine lactoferrin against Gardnerella species clinical isolates

Pino

Mazza

Matthews³

et al. 2022

Front. Microbiol.

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Gardnerella species play a key role in the development and recurrence of Bacterial Vaginosis (BV), a common imbalance of the vaginal microbiota. Because of the high rates of BV recurrence reported after treatment with standard of care antibiotics, as well as the emergence of antibiotic-resistant BV, the development of alternative treatment approaches is needed. Bovine lactoferrin, a well studied iron-binding glycoprotein with selective antimicrobial activity, may ameliorate vaginal dysbiosis either alone or in combination with antibiotics. The present study evaluated the antimicrobial resistance/susceptibility profile of seventy-one presumptive G. vaginalis clinical isolates to metronidazole and clindamycin. In addition, the in vitro antimicrobial activity of Metrodora Therapeutics bovine Lactoferrin (MTbLF) against the tested clinical isolates, both alone and in combination with metronidazole and clindamycin, was in depth evaluated using defined-iron culture conditions. All 71 presumptive G. vaginalis clinical isolates exhibited resistance to metronidazole, with MIC values greater than 256 μg/ml. Different susceptibility profiles were detected for clindamycin. In detail, the vast majority of the tested strains (45%), exhibiting MIC lower than 2 μg/ml, were considered sensitive; 18 strains (25%) with MIC higher or equal to 8 μg/ml, were classified as resistant, whereas the remaining 21 (30%) were classified as intermediate. MTbLF was tested in culture medium at different concentrations (32, 16, 8, 4, 2, 1, and 0.5 mg/ml) showing ability to inhibit the growth of the tested presumptive G. vaginalis clinical isolates, including those metronidazole-resistant, in a dose-dependent and not in a strain-dependent manner. MTbLF, at concentrations ranging from 32 to 8 mg/ml, exerted a statistically different antimicrobial activity compared with lower concentrations (4, 2, 1, and 0.5 mg/ml). A synergistic effect between MTbLF (8 and 4 mg/ml) and clindamycin was revealed for all the tested strains. When tested in the absence of other sources of iron, MTbLF did not support the growth of the tested presumptive G. vaginalis clinical isolates. Bovine lactoferrin may be a potential candidate to treat Gardnerella species infection.

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A clinical pilot study on the effect of the probiotic Lacticaseibacillus rhamnosus TOM 22.8 strain in women with vaginal dysbiosis

Cited by 32 publications

References 41 publications

Probiotics, a promising therapy to reduce the recurrence of bacterial vaginosis in women? a systematic review and meta-analysis of randomized controlled trials

Probiotics, a promising therapy to reduce the recurrence of bacterial vaginosis in women? a systematic review and meta-analysis of randomized controlled trials

Characterization of Bifidobacterium asteroides Isolates

Antimicrobial activity of bovine lactoferrin against Gardnerella species clinical isolates

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