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Rectal and Vaginal Eradication of Streptococcus agalactiae (GBS) in Pregnant Women by Using Lactobacillus salivarius CECT 9145, A Target-specific Probiotic Strain.
Martín, V, Cárdenas, N, Ocaña, S, Marín, M, Arroyo, R, Beltrán, D, Badiola, C, Fernández, L, Rodríguez, JM
Nutrients. 2019;(4)
Abstract
Streptococcus agalactiae (Group B Streptococci, GBS) can cause severe neonatal sepsis. The recto-vaginal GBS screening of pregnant women and intrapartum antibiotic prophylaxis (IAP) to positive ones is one of the main preventive options. However, such a strategy has some limitations and there is a need for alternative approaches. Initially, the vaginal microbiota of 30 non-pregnant and 24 pregnant women, including the assessment of GBS colonization, was studied. Among the Lactobacillus isolates, 10 Lactobacillus salivarius strains were selected for further characterization. In vitro characterization revealed that L. salivarius CECT 9145 was the best candidate for GBS eradication. Its efficacy to eradicate GBS from the intestinal and vaginal tracts of pregnant women was evaluated in a pilot trial involving 57 healthy pregnant women. All the volunteers in the probiotic group (n = 25) were GBS-positive and consumed ~9 log10 cfu of L. salivarius CECT 9145 daily from week 26 to week 38. At the end of the trial (week 38), 72% and 68% of the women in this group were GBS-negative in the rectal and vaginal samples, respectively. L. salivarius CECT 9145 seems to be an efficient method to reduce the number of GBS-positive women during pregnancy, decreasing the number of women receiving IAP during delivery.
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Prevention of Recurrent Acute Otitis Media in Children Through the Use of Lactobacillus salivarius PS7, a Target-Specific Probiotic Strain.
Cárdenas, N, Martín, V, Arroyo, R, López, M, Carrera, M, Badiola, C, Jiménez, E, Rodríguez, JM
Nutrients. 2019;11(2)
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Plain language summary
20–30% of infants suffer from recurrent acute otitis media (rAOM) which is usually treated with antibiotics, leading to increasing antimicrobial resistance rates. A bacterial strain, Lactobacillus salivarius PS7, was identified and characterised by in vitro studies which showed antimicrobial activity against most of otitis-related organisms. It was shown to be safe in rat toxicity studies. The investigators then carried out this prospective pilot study to test the efficacy and safety of L. Salivarius PS7 in infants and children with rAOM. 61 subjects completed the study and received the probiotic for the duration of 6 months. Oral intakes of L. salivarius PS7 over 6 months led to a statistically significant reduction (84%) in the number of episodes of AOM in comparison to those observed in the same children during the 6 months preceding probiotic intake. When AOM occurred, the duration of AOM episodes was shorter than in control children not receiving the probiotic. Ear samples showed that the probiotic treatment led to a statistically significant decrease in potential otopathogens. Limitations of this preliminary “proof of concept” trial were lack of placebo group and randomisation.
Abstract
Acute otitis media (AOM) is one of the most common bacterial infections in children. Empiric antibiotherapy leads to increasing antimicrobial resistance rates among otopathogens and may impair the correct development of the microbiota in early life. In this context, probiotics seem to be an attractive approach for preventing recurrent AOM (rAOM) through the restoration of the middle ear and nasopharyngeal microbiota. The aim of this study was the selection of a probiotic strain (Lactobacillus salivarius PS7), specifically tailored for its antagonism against otopathogens. Since L. salivarius PS7 was safe and displayed a strong antimicrobial activity against otopathogens, its efficacy in preventing rAOM was assessed in a trial involving 61 children suffering from rAOM. Children consumed daily ~1 × 10⁸ CFU of L. salivarius PS7, and the number of AOM episodes were registered and compared with that observed in the previous 6 and 12 months. The microbiota of samples collected from the external auditory canal samples was quantitatively and qualitatively assessed. The number of AOM episodes during the intervention period decreased significantly (84%) when compared to that reported during the 6 months period before the probiotic intervention. In conclusion, L. salivarius PS7 is a promising strain for the prevention of rAOM in infants and children.
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Superiority of a Split-dose Regimen of Sodium Picosulfate/Magnesium Citrate (SPMC) in Comparison to a Prior-day Schedule (AM/PM) for Colonoscopy Preparation. A Randomized Single-blinded Study.
Schulz, C, Müller, J, Sauter, J, Miehlke, S, Schmöcker, C, Hartmann, D, Malfertheiner, P, Badiola, C
Journal of gastrointestinal and liver diseases : JGLD. 2016;(3):295-302
Abstract
BACKGROUND AND AIMS Split-dose regimens are generally recommended for bowel cleansers. However, other regimens still remain in the summary of product characteristics of some bowel cleansers in Europe. The aim of this study is to compare the efficacy and safety of a split-dose regimen of sodium picosulfate/magnesium citrate (SPMC) with a prior-day schedule (AM/PM). METHODS Multicenter, randomized (EudraCT no. 2013-001620-20), endoscopist-blinded, parallel study, carried out in subjects 18 years or older undergoing elective colonoscopy. The primary endpoint was the bowel cleansing assessment using a binary transformation (adequate/inadequate) of the Global Preparation Assessment (GPA) scale. Additional parameters analyzed were the segmental assessment of bowel cleansing (RSS), the adenoma detection rate and safety evaluations. RESULTS 315 subjects comprised the ITT set. A significantly higher proportion of patients in the split-dose regimen had an adequate bowel preparation (AM/PM: 30.8% vs split-dose: 79.9%; p<0.0001). The mean global RSS was significantly lower in the split-dose group (AM/PM: 5.0 [SD: 2.91] vs split-dose: 2.6 [SD: 2.14]; p<0.0001). Flat polyps were detected in a higher proportion of subjects in the split-dose group compared with the AM/PM group (AM/PM: 16.0% vs split-dose: 22.0%). Both regimens were equally safe and well tolerated, with no serious treatment-emergent adverse events or discontinuations due to adverse events. CONCLUSION A split-dose regimen of SPMC is superior to the AM/PM regimen administered the day before colonoscopy. Split regimen of SPMC should be considered the standard of use.
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A randomized trial to compare the efficacy and tolerability of sodium picosulfate-magnesium citrate solution vs. 4 L polyethylene glycol solution as a bowel preparation for colonoscopy.
Muñoz-Navas, M, Calleja, JL, Payeras, G, Hervás, AJ, Abreu, LE, Orive, V, Menchén, PL, Bordas, JM, Armengol, JR, Carretero, C, et al
International journal of colorectal disease. 2015;(10):1407-16
Abstract
PURPOSE The purpose of this study is to compare the efficacy and acceptability of an evening-before regimens of sodium picosulfate/magnesium citrate (SPMC) and polyethylene glycol (PEG) as bowel cleansers and to explore the results of a same-day regimen of SPMC. METHODS Multicenter, randomized, observer-blinded, parallel study carried out in subjects who were 18-80 years old and were undergoing diagnostic colonoscopy for the first time. The primary outcome was treatment success, which was a composite outcome defined by (1) the evaluation of the overall preparation quality as "excellent" or "good" by two blinded independent evaluators with the Fleet(®) Grading Scale for Bowel Cleansing and (2) a subject's acceptability rating of "easy to take" or "tolerable." The primary outcome was analyzed using a logistic regression with site, gender, and age group (age ≥65 years and <65 years) as factors. RESULTS Four hundred ninety subjects were included in the efficacy evaluation. Although treatment success was significantly higher in subjects assigned to the evening-before regimen of SPMC vs. subjects assigned to the evening-before PEG, when evaluating the two individual components for treatment success, there were significant differences in the ease of completion but not in the quality of preparation. The same-day SPMC regimen was superior to both the evening-before regimen of SPMC and PEG in terms of the quality of preparation, especially regarding the proximal colon. CONCLUSIONS An evening-before regimen of SPMC is superior to an evening-before regimen of PEG in terms of subject's acceptability. The same-day SPMC regimen provides better cleansing levels in the proximal colon.