Rectal and Vaginal Eradication of Streptococcus agalactiae (GBS) in Pregnant Women by Using Lactobacillus salivarius CECT 9145, A Target-specific Probiotic Strain.

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.

Prevention of Recurrent Acute Otitis Media in Children Through the Use of Lactobacillus salivarius PS7, a Target-Specific Probiotic Strain.

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.

[Assessment of the erectile function and patients' perception of improvement in Spanish patients with erectile dysfunction]. / Evaluación de la función eréctil y la percepción de mejoría en pacientes españoles con disfunción eréctil.

OBJECTIVE: This study has been carried out to assess the hardness of erection and the perception of improvement in erectile function with the treatments received during the last month. MATERIAL AND METHOD: Descriptive, observational, multicenter, cross-sectional study carried out in 30 urology sites in Spain. Patients diagnosed of erectile dysfunction receiving treatment during at least the last month have been enrolled. Hardness of erection has been assessed with the erection hardness score and improvement perception has been estimated with the global assessment question. RESULTS: A 63% of patients had a hardness of erection that was insufficient for penetration, but 75% of patients referred that their erectile function had improved with treatment. After adjustment for other factors, erection hardness score values were not significantly different among patients being treated with alprostadil topical cream, compared to patients being treated with the combination of phosphodiesterase 5 (PDE5) inhibitors plus alprostadil topical cream or with PDE5i other than sildenafil alone. However, patients treated with alprostadil topical cream had a significantly higher chance of referring an improvement in their erectile function compared to patients treated with PDE5i, despite the fact that they had received treatment for a shorter period of time. CONCLUSION: Hardness of erection is just another factor of erectile function, but it is not the only one influencing improvement perception by patients.

Probiotic supplementation with Lactobacillus plantarum and Pediococcus acidilactici for Helicobacter pylori therapy: A randomized, double-blind, placebo-controlled trial.

OBJECTIVE: To evaluate the safety, tolerability and efficacy of a probiotic supplementation for Helicobacter pylori (H. pylori) eradication therapy. DESIGN: Consecutive adult naive patients with a diagnosis of H. pylori infection who were prescribed eradication therapy according to clinical practice (10-day triple or nonbismuth quadruple concomitant therapy) randomly received probiotics (1 × 109 colony-forming units each strain, Lactobacillus plantarum and Pediococcus acidilactici) or matching placebo. Side effects at the end of the treatment, measured through a modified De Boer Scale, were the primary outcome. Secondary outcomes were compliance with therapy and eradication rates. RESULTS: A total of 209 patients (33% triple therapy, 66% non-bismuth quadruple therapy) were included [placebo (n = 106) or probiotic (n = 103)]. No differences were observed regarding side effects at the end of the treatment between groups (ß -0.023, P 0.738). Female gender (P < 0.001) and quadruple therapy (P 0.007) were independent predictors of side effects. No differences in compliance were observed, regardless of the study group or eradication therapy. Eradication rates were similar between groups [placebo 95% (95% confidence interval (CI), 89% to 98%) vs probiotic 97% (95% CI, 92% to 99%), P 0.721]. There were no relevant differences in cure rates (>90% in all cases) between triple and quadruple concomitant therapy. CONCLUSION: Probiotic supplementation containing Lactobacillus Plantarum and Pediococcus acidilactici to H. pylori treatment neither decreased side effects nor improved compliance with therapy or eradication rates.

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.

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.

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.

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.

Women, patients with severe asthma, and patients attended by primary care physicians, are at higher risk of suffering from poorly controlled asthma.

AIM: The aim of this exploratory study was to identify those factors associated with asthma control assessed according to GINA Guidelines. METHOD: 809 (56% female) subjects with asthma were recruited consecutively from both specialist and primary care centres. Asthma control was assessed over a 4-week follow-up period using a composite measure. A multivariate analysis was performed, in which asthma control was included as the dependent variable and several explanatory variables were included as independent variables. RESULTS: Analysis performed on the whole population rendered gender (p=0.003), the type of physician (p<0.001), and age group (p<0.001), as significant factors associated with asthma control. In adults, gender (p=0.001), asthma severity (p<0.001), and type of physician (p<0.001) were significant, and only asthma severity was significant (p=0.043) in children. CONCLUSIONS: After model adjustment, we suggest that being female, suffering from more severe asthma, or being attended by a primary care physician, could pose a significantly higher risk of having poorly controlled asthma in adults.

Validation of the Spanish version of the Asthma Control Questionnaire.

BACKGROUND: The Asthma Control Questionnaire (ACQ) has not been validated in the Spanish population, and the fact that it requires spirometry poses an important limitation on its widespread use in the primary care setting in Spain. OBJECTIVE: The aim of this study was to evaluate the psychometric properties of the Spanish version of the ACQ. METHODS: In this multicenter, prospective study, consecutive adult patients with persistent asthma were recruited at 62 respiratory and allergy units across Spain. Patients were assessed at baseline and at weeks 2 and 6. The following clinical variables were recorded: lung function (forced expiratory volume in 1 second [FEV(1)]), symptoms, exacerbations, concomitant diseases, asthma severity according to the Global Initiative for Asthma international guideline, and asthma control as perceived by patients and physicians through direct ad hoc questions. The latter measures were derived specifically for this study. Patients self-completed the ACQ at all visits before the rest of the study variables were recorded. The ACQ's feasibility, validity, reliability, and sensitivity to change were assessed. Cross-sectional and longitudinal validity was assessed using the relationship between ACQ score and clinical parameters. Sensitivity to change was assessed by estimating the global effect size and the minimal important difference (MID). Reliability was assessed using estimation of the Cronbach alpha coefficient (CCalpha) and intraclass correlation coefficient (ICC). RESULTS: A total of 607 patients were included. The mean (SD) age was 45.6 (17.1) years and 61.4% of the patients were women. Of these 607, 235 (39%) had mild asthma; 246 (41%), moderate; and 126 (21%), severe. Mean (SD) time to complete the ACQ was 3.9 (4.4) minutes. The Pearson correlation coefficient in the relationship between ACQ and FEV(1) (% predicted value) was -0.23. ACQ was found to be significantly related to asthma severity and intensity and frequency of symptoms (coughing, wheezing, and dyspnea) (both, P < 0.001). Change in ACQ was significantly related to changes in FEV(1), intensity and frequency of symptoms, and number of exacerbations (all, P < 0.001). The global effect size of ACQ was 0.46 and the MID was 0.47 point of a maximum of 6. CCalpha was 0.90 and ICC was 0.86. CONCLUSION: In these adults with asthma in Spain, the Spanish version of the ACQ was found to be a reliable and valid questionnaire, suggesting that it can be used in this population as a discriminative and evaluative instrument.

[Assessment of the simplified versions of the Asthma Control Questionnaire]. / Evaluación de las versiones simplificadas del Cuestionario de Control del Asma.

BACKGROUND AND OBJECTIVE: The aim of this study was to assess the measurement properties of the Spanish version of Asthma Control Questionnaire (ACQ) when FEV1 item in the original version (ACQ-FEV1) is substituted by peak expiratory flow rate (ACQ-PEF) and when the lung function item is omitted (ACQ-wLF). MATERIAL AND METHOD: and 607 patients were enrolled in this study. Three study visits were carried out: at baseline, 2, and 6 weeks later. Validity, reliability and sensitivity to change of both ACQ versions were calculated. RESULTS: ACQ-PEF and ACQ-wLF had a correlation coefficient of 0.38 and 0.39 with no exacerbations. Both symptoms improvement and a better perception of asthma control, both by physicians and patients, were significantly related ro better scores in both versions (P <0.01). Cronbach a of ACQ-PEF and ACQ-wLF were 0.83 and 0.87, respectively. Intraclass correlation coefficients of both ACQ-PEF and ACQ-wLF were 0.9 and 0.87. Mean scores of all ACQ versions (ACQ-FEV1, ACQ-PEF and ACQ-wLF) were 1.31 (1), 1.34 (1) and 1.14 (1.1), respectively, being all differences statistically significant P < or = 0.003). CONCLUSIONS: Replacement of FEV1 by PEF, or its elimination, does not alter the measurement properties of the ACQ questionnaire. Use of ACQ simplified versions is recommended only for investigational purposes, without combining in the same analysis scores obtained with different versions of the questionnaire.

Effect of fluticasone propionate-salmeterol therapy on seasonal changes in airway responsiveness and exhaled nitric oxide levels in patients with pollen-induced asthma.

BACKGROUND: There has been concern that in allergic asthmatic patients there might be an interactive effect on inflammation between regular salmeterol use and exposure to allergens, resulting in increased airway responsiveness. OBJECTIVE: To determine the effects of salmeterol on allergen-induced changes in airway responsiveness and exhaled nitric oxide (ENO) levels in allergic asthmatic patients concomitantly taking inhaled corticosteroids. METHODS: Forty-two asthmatic patients sensitized to pollen allergens were randomly allocated to treatment with fluticasone propionate-salmeterol (n=21) or fluticasone propionate alone (n=21). Spirometry, the methacholine provocation concentration causing a 20% decline in forced expiratory volume in 1 second (PC20), the adenosine 5'-monophosphate (AMP) PC20, and ENO levels were measured before and at the height of the pollen season after 6 weeks of treatment. RESULTS: Changes in the methacholine PC20, the AMP PC20, and ENO levels were not significantly different between treatment groups. No significant changes in the AMP PC20 were observed among the fluticasone propionate-salmeterol and fluticasone propionate groups during natural pollen exposure. However, a significant increase in the methacholine PC20 was observed in the fluticasone propionate-salmeterol group (P = .03) and in the fluticasone propionate group (P = .04); ENO concentrations decreased significantly in both groups during natural allergen exposure (P = .009 and .005). CONCLUSIONS: In patients with pollen-induced asthma, treatment with either fluticasone propionate or fluticasone propionate-salmeterol is associated with significant reductions in methacholine responsiveness and ENO concentrations, even during natural pollen exposure. Furthermore, at least in patients with mild asthma, natural allergen exposure and the regular use of fluticasone propionate-salmeterol are not associated with a greater increase in ENO levels and airway responsiveness than natural allergen exposure and fluticasone propionate use alone.

Differences in asthma clinical outcomes according to initial severity.

UNLABELLED: Information on asthma morbidity outcomes in relation to the initial degree of severity is scarce. OBJECTIVE: To determine the differences in asthma morbidity, quality of life (QOL), and lung function outcomes according to the initial severity of the illness. METHOD: A cohort of 235 (102 mild, 69 moderate, and 64 severe) asthma patients was followed up for 3 years. The following parameters were collected for all patients: asthma morbidity, clinical data, spirometry, and St. George's Respiratory Questionnaire (SGRQ). RESULTS: A significant reduction in asthma morbidity and an improvement in pulmonary function and QOL were observed in the total group 3 years later. However, when the sample was stratified according to the initial severity, differences were observed between means in the third year compared with the first year in the following: number of primary care visits (patient/year) due to asthma: mild -1 (95% CI: -1.42 to -0.56); moderate -0.9 (-.92 to 0.18); and severe 1 (-0.23 to 2.27) (p = 0.020); FEV, (%): mild 8.5 (-5.3 to 11.6), moderate -0.3 (-3.2 to 2.6), and severe -1.5 (-5 to 2) (p < 0.001); and total score of the SGRQ: mild -9.8 (-12.2 to -7.3), moderate -9.1 (-12.9 to -5.2), and severe -7.9 (-11.9 to -3.9) (p < 0.001). CONCLUSIONS: We conclude that asthma prognosis varies according to the initial severity. Clinical, QOL, and pulmonary function outcomes in the mild asthma group are better than in the moderate and severe groups.

Phenol-containing saline solution as a diluent for adenosine 5'-monophosphate in bronchial challenge testing.

OBJECTIVES: To investigate the effect of dissolving adenosine 5'-monophosphate (AMP) with phenol-containing saline solution on the stability and the bronchoconstrictive properties of this indirect agonist. METHODS: Eleven subjects with asthma well controlled with short-acting inhaled beta2-agonists as required or with inhaled corticosteroids were studied. Bronchial challenge tests with AMP dissolved with either normal saline solution or saline solution containing 0.4% phenol were performed on separate days. Furthermore, to assess the potential influence of the phenol-containing saline solution on the stability of the bronchoconstrictor agent, AMP solutions in concentrations of 40 microg/mL and 400 microg/mL were prepared in saline solution and phenol-containing saline solution and, after 30 min, the AMP levels were determined by high-performance liquid chromatography (HPLC) assay. RESULTS: The geometric mean AMP provocative concentration causing a 20% fall in FEV1 (PC20) was 13.49 mg/mL (95% confidence interval [CI], 6.76 to 26.91) for the saline solution method, and AMP PC20 for the saline solution with phenol method was 8.91 mg/mL (95% CI, 3.39 to 23.44) [p = 0.18]. No significant differences were found between the concentrations of AMP made in saline solution compared to those made in phenol-containing saline solution measured by HPLC. CONCLUSION: These observations indicate that normal saline solution with or without phenol can be used as the diluent for AMP. However, since a potential risk with AMP of industrial sources is the bacterial contamination, adding a preservative such as phenol to a saline solution diluent might be recommended.

Use of a mixture of gadolinium and iodinated contrast for angiography.

The purpose of this study was to determine if the image quality of gadolinium digital subtraction angiography (DSA) can be improved by the addition of small quantities of iodinated contrast to gadolinium. The optical density (OD) of a mixture of four parts gadolinium-based contrast to one part iodinated contrast was measured through a phantom study and compared to that of full-strength gadolinium, full strength iodinated contrast, and a 20% solution of iodinated contrast. We also compared the clinical image quality of the mixture of gadolinium-based contrast and iodinated contrast relative to full-strength gadolinium and full strength iodinated contrast during DSA. The DSA image quality of the gadolinium-iodinated contrast mixture was significantly improved relative to images obtained with full-strength gadolinium and compared favorably to that obtained with full-strength iodinated contrast. The phantom data showed that the OD of the gadolinium-iodinated contrast mixture was much greater than that of full strength gadolinium and the 20% iodinated contrast solution. The increase in OD was greater than that expected from a simple additive effect of the OD of the contrast agents. Adding a small amount of iodinated contrast to gadolinium results in a significant improvement in the radiographic density and DSA image quality of gadolinium. This simple technique appears to overcome one of the major limitations of gadolinium-based angiography-poor radiographic density-while continuing to minimize the volume of administered iodinated contrast.

Patient perception and acceptability of multidose dry powder inhalers: a randomized crossover comparison of Diskus/Accuhaler with Turbuhaler.

This study was designed to provide information on correct use and preference to features and device handling of two multidose dry powder inhalers, the Diskus/Accuhaler and the Turbuhaler. A total of 169 powder-naive patients (mean age 40 years) with asthma or chronic obstructive pulmonary disease (COPD) were enrolled in a randomized crossover comparison of both inhalers. An effective use of either inhaler was assessed before (leaflet only) and after inhaler education. Ease of use especially during an attack and the presence of a dose counter were regarded as the most important features for an ideal inhaler. The percentage of correct handling maneuvers and the percentage of patients achieving 100% of correct maneuvers increased significantly (p < 0.001) after inhaler education in both devices, but percentage of correct use after the intervention was significantly higher for the Diskus/Accuhaler (92.6%) than for the Turbuhaler (89.8%; p = 0.036). Overall 60% of patients thought the Diskus/Accuhaler was preferable to the Turbuhaler (p < 0.001). The main reasons given were presence of a dose counter, perceived ease of use including ease of learning to use, design, and attached cover. Among those who preferred the Turbuhaler device, the main reason cited was small size, discreetness, and ease of holding. In the multivariate analysis, inhaler education (p = 0.005) and education level (p = 0.009) were significantly associated with the percentage of correct maneuvers. Age, sex, or tested inhaler showed no effect on appropriateness of the inhalation technique.