A critical analysis of the effect of OM-85 for the prevention of recurrent respiratory tract infections or wheezing/asthma from systematic reviews with meta-analysis.

Acute respiratory tract infections (RTIs) are one of the most common causes of pediatric consultations/hospitalizations and a major trigger for asthma exacerbations. Some consensus statements have recommended the use of immunostimulants to boost natural defenses against severe or repeated infections. One of the most common immunostimulants is OM-85; while several randomized clinical trials (RCTs) have evaluated its efficacy in preventing acute RTIs and wheezing/asthma exacerbations, results have been conflicting. Similarly, various systematic reviews with meta-analyses (SRMs) on OM-85 have used different strategies, populations, and outcomes; moreover, SRM conclusions are limited when the original studies are highly heterogeneous or have a low quality, hindering the generalizability of the findings. Here we summarize the evidence on the effect of OM-85 to prevent acute RTIs, wheezing/asthma episodes, or loss of asthma control in children, by including and critically evaluating all SRMs published to date. We searched for SRMs on OM-85 in three publication databases and found nine SRMs (seven for RTI, and two for wheezing/asthma). Among those, one had a high confidence evaluation of quality (AMSTAR-2 tool) and found a reduction in the total number of acute RTIs among the OM-85 group. Overall, no strong recommendations can be derived from the existing literature, mainly due to the high heterogeneity among included RCTs and SRMs. Further, large, high-quality RCTs are needed to confirm the true efficacy of OM-85 for the prevention of acute RTIs, asthma development, and asthma exacerbations.

Psychometric properties of the Spanish version of the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM) in Chile.

OBJECTIVE: To examine the psychometric properties of the Spanish version of the 34-item Clinical Outcomes in Routine Evaluation-Outcome Measure questionnaire (CORE-OM). METHOD: Psychometric exploration was conducted in two samples: non-clinical (n = 706) and clinical (n = 420) participants. The non-clinical sample comprised a subgroup of community members (n = 308) and students (n = 398). The clinical sample consisted of self-reported patients (n = 209) and outpatients (n = 211). The analysis included both internal and test-retest reliability, convergent validity, and principal component analysis. A reliable change index and clinical cut-off scores were established for assessing clinically significant change. RESULTS: The Spanish CORE-OM demonstrated good internal consistency and test-retest reliability, along with satisfactory convergent validity against the 45-item Outcome Questionnaire (OQ-45.2). There were strong differentiations between the clinical and non-clinical samples and the four sample subsets. The outpatient group reported the highest scores, while the community group exhibited the lowest scores. There were no marked gender effects. All observed patterns aligned closely with the established Spanish referential data. CONCLUSION: Our findings provide support for the utilization of the Spanish CORE-OM as a measure for tracking psychotherapeutic progress in the context of Chile.

Estimation of Spatio-Temporal Parameters of Gait and Posture of Visually Impaired People Using Wearable Sensors.

In rehabilitating orientation and mobility (O&M) for visually impaired people (VIP), the measurement of spatio-temporal gait and postural parameters is of specific interest for rehabilitators to assess performance and improvements in independent mobility. In the current practice of rehabilitation worldwide, this assessment is carried out in people with estimates made visually. The objective of this research was to propose a simple architecture based on the use of wearable inertial sensors for quantitative estimation of distance traveled, step detection, gait velocity, step length and postural stability. These parameters were calculated using absolute orientation angles. Two different sensing architectures were tested for gait according to a selected biomechanical model. The validation tests included five different walking tasks. There were nine visually impaired volunteers in real-time acquisitions, where the volunteers walked indoor and outdoor distances at different gait velocities in their residences. The ground truth gait characteristics of the volunteers in five walking tasks and an assessment of the natural posture during the walking tasks are also presented in this article. One of the proposed methods was selected for presenting the lowest absolute error of the calculated parameters in all of the traveling experimentations: 45 walking tasks between 7 and 45 m representing a total of 1039 m walked and 2068 steps; the step length measurement was 4.6 ± 6.7 cm with a mean of 56 cm (11.59 Std) and 1.5 ± 1.6 relative error in step count, which compromised the distance traveled and gait velocity measurements, presenting an absolute error of 1.78 ± 1.80 m and 7.1 ± 7.2 cm/s, respectively. The results suggest that the proposed method and its architecture could be used as a tool for assistive technology designed for O&M training to assess gait parameters and/or navigation, and that a sensor placed in the dorsal area is sufficient to detect noticeable postural changes that compromise heading, inclinations and balancing in walking tasks.

Brazilian organic propolis for prevention and treatment of radiation-related oral acute toxicities in head and neck cancer patients: A double-blind randomized clinical trial.

Background: Oral mucositis (OM) is one of the most important acute toxicities from radiotherapy (RT) in head and neck cancer patients and can impair oncologic treatment. Dysphagia, dysgeusia, pain, and oral candidiasis are other common toxicities. Brazilian Organic Propolis (BOP) is a recently described propolis variant and BOP types 4 and 6 have shown important antioxidant, anti-inflammatory, and antifungal properties. Purpose: To investigate the use of BOP as a preventive and/or complementary therapeutic option for radiotherapy-induced oral mucositis, dysphagia, dysgeusia, pain, and oral candidiasis. Additionally, proinflammatory cytokines were assessed to investigate their anti-inflammatory role. Methods: Sixty patients were included in this randomized, double-blind, controlled clinical trial. Patients were randomized to receive either aqueous suspension of a BOP or placebo throughout RT. Also, all patients underwent low-level laser therapy as routine oral care. OM, dysphagia, and dysgeusia were assessed weekly according to WHO and NCI scales. Pain-related to OM was assessed according to a Visual Analog Scale and the presence or absence of oral candidiasis was checked by intraoral examination. Protein levels of TNF-α and IL-1ß from oral mucosa were assessed by ELISA. Results: Patients in the propolis group had a lower mean score of OM, dysphagia, dysgeusia, and most patients reported moderate pain. Fewer patients developed oral candidiasis in the propolis group, and the number of episodes was lower among patients that used BOP (p < 0.05). In addition, the BOP group presented significantly lower levels of IL-1ß since the beginning of treatment when compared with placebo patients (p < 0.05) and a lower level of TNF-α at the end of treatment (p < 0.001). Conclusion: Topic use of BOP reduced TNF-α and IL-1ß levels, oral candidiasis episodes, and seems to be a useful complementary option for the prevention and treatment of the main acute oral toxicities of RT. Clinical Trial Registration: http://www.ensaiosclinicos.gov.br/rg/RBR-9f8c78/, identifier RBR-9f8c78.

Airway Administration of Bacterial Lysate OM-85 Protects Mice Against Respiratory Syncytial Virus Infection.

Respiratory syncytial virus (RSV) is a seasonal pathogen responsible for the highest percentage of viral bronchiolitis in pediatric patients. There are currently no vaccine available and therapeutic methods to mitigate the severity of RSV bronchiolitis are limited. OM-85, an oral standardized bacterial lysate isolated from human respiratory strains and widely used to prevent recurrent infections and/or exacerbations in populations at risk, has been shown to be effective and safe in children and adults. Here, we demonstrate that airway administration of OM-85 in Balb/c mice prior to infection prevents RSV-induced disease, resulting in inhibition of viral replication associated with less perivascular and peribronchial inflammation in the lungs. These protective effects are dose and time-dependent with complete protection using 1mg dose of OM-85 only four times intranasally. Mechanistic insights using this topical route in the airways revealed increased alveolar macrophages, a selective set of tolerogenic DCs, Treg and Th1 expansion in the lung, even in the absence of infection, contributing to a better Th1/Th2 balance and preventing ILC2 recruitment in the airways and associated inflammatory sequelae. OM-85 preventive treatment also improved antiviral response by increasing IFNß and its responsive genes in the lung. In vitro, OM-85 protects against RSV infection in a type I interferon pathway. Our animal model data suggest that intranasal use of OM-85 should be considered as a potential prophylactic product to prevent RSV bronchiolitis once human studies confirm these findings.

Servicios psicológicos afirmativos para personas LGTBIQA+ en Ecuador: cambios en el malestar psicológico / Affirmative psychological services for LGTBIQA+ persons in Ecuador: changes in psychological distress

Resumen: Antecedentes: Aunque en el mundo anglosajón la Terapia Afirmativa tiene un amplio recorrido con un respaldo empírico contundente, en Iberoamérica su desarrollo es reciente. Objetivo: Analizar la Evidencia Basada en la Práctica de una red de servicios de psicología afirmativa para personas LGTBIQA+ en Ecuador. Método: Estudio naturalístico en el que se analiza la Evidencia Basada en la Práctica generada usando el Clinical Outcomes in Routine Evaluation - Outcome Measure como herramienta de evaluación rutinaria para monitorizar los resultados de 101 consultantes que recibieron Terapia Afirmativa entre 2018 y 2020 en una red de servicios de psicología afirmativa para personas LGTBIQA+. Se evaluó el cambio estadísticamente significativo y el cambio confiable y clínicamente significativo. Resultados: Lxs participantes tenían en promedio 27.14 años. La mediana de sesiones fue seis. Hubo cambios estadísticamentes significativos para quienes completaron el cuestionario al menos dos veces. Se encontró un tamaño del efecto grande para el puntaje total y todas las dimensiones, a excepción de Riesgo. El 68% de los participantes presentaron mejoría. Conclusiones: Los resultados sugieren que la Terapia Afirmativa minimiza el riesgo que trae consigo el estrés de minorías. Se invita a estudiantes, terapeutas y usuarios a aprender, adoptar y acudir a Terapia Afirmativa, respectivamente.

Abstract: Background: Although in the Anglo-Saxon world Affirmative Therapy has a long history with strong empirical support, in Ibero-America its development is recent. Objective: To analyze the Practice-Based Evidence of a network of affirmative psychology services for LGTBIQA+ persons in Ecuador. Methods: This is a naturalistic study analyzing Practice-Based Evidence generated using the Clinical Outcomes in Routine Evaluation - Outcome Measure as a routine evaluation tool to monitor the outcomes of 101 clients who received Affirmative Therapy between 2018 and 2020 in a network of affirmative psychology services for LGTBIQA+ people. Statistically significant change and reliable, clinically meaningful change were assessed. Results: Participants were on average 27.14 years old. The median number of sessions was six. There were statistically significant changes for those who completed the questionnaire at least twice. A large effect size was found for the total score and all dimensions except for Risk. Sixty-eigth percent participants showed improvement. Conclusions: The results suggest that Affirmative Therapy minimizes the risk brought on by minority stress. Students, therapists, and clients are encouraged to learn, adopt, and use Affirmative Therapy, respectively.

What Happens When Individuals Answer Questionnaires in Two Different Languages.

The aim of the present study was to compare scores from the English and the Spanish versions of two well-known measures of psychological distress using a within-subject approach. This method involved bilingual participants completing both measures in four conditions. For two groups of people, measures were offered in the same language both times and for the other two groups, each language version was offered, the order differing between the groups. The measures were the Clinical Outcomes in Routine Evaluation-Outcome Measure and the Schwartz Outcome Scale-10, both originally created in English and then translated to Spanish. In total, 109 bilingual participants (69.7% women) completed the measures in two occasions and were randomly allocated to the four conditions (English-English, English-Spanish, Spanish-English and Spanish-Spanish). Linear mixed effects models were performed to provide a formal null hypothesis test of the effect of language, order of completion and their interaction for each measure. The results indicate that for the total score of the Clinical Outcomes in Routine Evaluation-Outcome Measure just language had a significant effect, but no significant effects were found for completion order or the language by order interaction. For the Schwartz Outcome Scale-10 scores, none of these effects were statistically significant. This method offers some clear advantages over the more prevalent psychometric methods of testing score comparability across measure translations.

Exploration of the psychometric properties of the Clinical Outcomes in Routine Evaluation-Outcome Measure in Ecuador.

BACKGROUND: The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a pan-theoretical and pan-diagnostic measure of mental health designed to cover issues that people wish to change in psychotherapy. The objective of this study was to explore the psychometric properties of the Spanish translation of the CORE-OM, in a country, Ecuador for which there is not a single measure suitable for this purpose with empirically demonstrated local acceptability and psychometric properties. METHODS: In total, 886 adults not currently receiving psychotherapy treatment or taking psychotropic medication were included in the analysis. The analyses broadly followed and compared with results from previous studies. These analyses consisted of assessment of acceptability, internal consistency, test-retest reliability, influences of demographic variables, correlations between domain scores, and convergent validity with Spanish versions of the Outcome Questionnaire 45.2 and Schwartz Outcome Scale-10. RESULTS: The questionnaire showed good acceptability (overall omission rate of 0.56%), good reliability (α = .93 [.92, .94], test-retest correlations ranged from .59 to .85), and good convergent validity with the Outcome Questionnaire 45.2 (r = .84) and the Schwartz Outcome Scale-10 (r = -.73). Statistically significant gender differences were found in two domains: females scored higher on Well-being (M = 1.23) than males (M = 1.01), though effect size was small (g = 0.31); and males (M = 0.31) scored higher than females on Risk (M = 0.25), with even smaller effect size (g = 0.06). Age was negatively correlated with psychological distress in all domains and coefficients ranged from -.14 for Risk to -.29 for Functioning. CONCLUSIONS: The results support the use of the CORE-OM as a valid and reliable instrument in a non-clinical Ecuadorean population. Exploration of the psychometric properties in a clinical population is recommended to assure its use in clinical settings.

Paediatric Recurrent Ear, Nose and Throat Infections and Complications: Can We Do More?

Recurrent respiratory tract infections (rRTIs), of which there are three main groups-otitis media, tonsillitis and sinusopathies-are very common in paediatric populations and are associated with significant morbidity and mortality due to complications. These infections substantially reduce quality of life for paediatric patients and their families and are a significant personal, medical and economic burden on the patients, the patients' families and the healthcare system. Most rRTIs are of viral origin; however, indiscriminate use of antibiotics in their treatment has led to development of bacterial resistance. Effective management of rRTIs to reduce the burden of disease and to avoid overuse of antibiotics has become a great therapeutic challenge. New strategies for the management of paediatric rRTIs include focus on prevention using non-specific immunomodulators to boost the body's natural defences against infection and to downregulate infection- and allergen-induced airway inflammation. The oral immunomodulator, OM-85, a bacterial lysate, acts on the innate and adaptive branches of the immune system, conferring protection against viral and bacterial infections, and controls inflammation, thereby reducing tissue damage. OM-85 has demonstrated good tolerability and clinical efficacy in reducing the number and duration of RTIs in children with recurrent airway infections. It has also been reported to reduce the use of concomitant medications, including antibiotics, time to cure and school absenteeism. OM-85 is efficacious and well tolerated when administered concomitantly with inactivated influenza vaccine (IIV) and has been shown to reduce wheezing attacks induced by RTI in young children. Clinical results show that the greater the risk of rRTIs, the greater the benefit with OM-85. OM-85 may be considered a promising tool to add to the limited armamentarium of the ear, nose and throat (ENT) physician dealing with rRTIs and their complications, such as recurrent wheeze and asthma inception.

The Clinical Outcomes in Routine Evaluation-Outcome Measure: A useful option for routine outcome monitoring in Latin America / Clinical Outcomes in Routine Evaluation-Outcome Measure: Uma opção útil para o monitoramento de rotina dos resultados na América Latina / Clinical Outcomes in Routine Evaluation-Outcome Measure: Una opción útil para la monitorización rutinaria de resultados en Latinoamérica

Latin American mental health services are moving from the psychiatric hospital model to a community-based model. The effectiveness of these new services needs to be evaluated and that can be done through routine outcome monitoring. The present communication introduces the Clinical Outcomes in Routine Evaluation – Outcome Measure (CORE-OM), a free instrument, supported with rigorous psychometric exploration, and which has been translated to Spanish and Brazilian Portuguese that can be used for monitoring purposes across the region.

Os serviços de saúde mental latino-americanos estão mudando do modelo de hospital psiquiátrico para um modelo baseado em atendimento comunitário. A eficácia desses novos serviços precisa ser avaliada através do uso de monitoramento de resultados de rotina. Esta comunicação apresenta o Clinical Outcomes in Routine Evaluation – Outcome Measure (CORE-OM), um instrumento gratuito, suportado por rigorosos exames psicométricos, que foi traduzido para o espanhol e o português do Brasil e que pode ser usado com a finalidade de monitorar resultados na região.

Los servicios de salud mental latinoamericanos están moviéndose del modelo de hospital psiquiátrico a un modelo basado en la atención comunitaria. La efectividad de estos nuevos servicios necesita ser evaluada por medio del uso de la monitorización rutinaria de los resultados. La presente comunicación introduce el Clinical Outcomes in Routine Evaluation – Outcome Measure (CORE-OM), un instrumento gratuito, apoyado por rigurosas exploraciones psicométricas, el cual ha sido traducido al español y al portugués brasileño, y que puede ser usado con el propósito de monitorización de resultados en la región.

Cost-effectiveness analysis of OM-85 vs placebo in the prevention of acute respiratory tract infections (ARTIs) in children that attend day-care centers.

BACKGROUND: Children that attend day-care centers frequently contract acute respiratory tract infections (ARTIs). ARTIs represent a burden for both children and parents. Systematic reviews on the use of immunostimulants for the prevention of juvenile recurrent ARTIs have provided moderate evidence of efficacy and safety. The aim of the study was to establish whether the immunostimulant, OM-85, was cost-effective in preventing ARTIs in children 2-6 years old that attended day-care centers or preschools in Mexico. We performed a systematic review to evaluate the efficacy of OM-85. For costs, we assumed an institutional perspective, which included the costs of care and supplies over a study period of six months, during the autumn-winter seasons. We created decision trees and constructed a model to identify pharmacoeconomic parameters. We generated 1000 estimations with the bootstrap method to calculate descriptive statistics of pharmacoeconomic parameters. We evaluated cost-effectiveness compared to treatment without immunostimulants. RESULTS: The mean (SD) incidences of ARTIs were 5.59 ± 0.29 without immunostimulants and 2.97 ± 0.32 with OM-85, during the study period. The mean (25th, 75th percentile) direct costs of ARTIs were 57.04 (37.11, 76.39) US$ (US dollars) without immunostimulants and 48.53 (37.35, 58.93) US$ with OM-85, with a mean increment of - 8.51(- 17.08, 0.75) US$, and a mean cost-effectiveness of - 17.94 (- 36.48, 1.66) US$. The direct costs plus the cost of one parent missing work to care for the child with ARTI were 125.76 (102.83, 150.16) US$, without immunostimulant and 85.21 (72.15, 98.81) US$, with OM-85. The increment was - 40.55 (- 68.29, - 13.95) US$, and the cost-effectiveness was - 86.89 (- 142.37, - 29.34) US$.Part of the cost reduction was ascribed to the reduced use of medications, particularly antibiotics. CONCLUSIONS: Our results were consistent with previous clinical studies conducted in closed institutions in Mexico. OM-85 reduced the number of ARTIs and the frequency of antibiotics use. We concluded that OM-85 was cost-effective for preventing ARTIs in children that attended day-care centers, particularly when parental absenteeism was covered by the institutions.

Rol de los lisados bacterianos en asma, evidencia y proyección con especial referencia a OM-85 / Role of bacterial lysates in asthma, evidence and projection with special reference to OM-85

Existen diversos lisados bacterianos, siendo OM-85 (Broncho-Vaxom®) el que posee mayor evidencia en cuanto a su rol inmunoprotector sobre infecciones respiratorias en población pediátrica. Sus mecanismos de acción producen efectos inmunomoduladores que potencialmente podrían prevenir el asma en etapas precoces de la vida, actuar sobre la disminución de crisis y ser un aporte a la terapia convencional del asma. Este artículo expone las principales evidencias en relación con estos compuestos, con enfoque en la actualidad y el desarrollo futuro, en especial sobre OM-85.

There are several bacterial lysates, being OM-85 (Broncho-Vaxom®) the one with the greatest evidence regarding its immunoprotective role on respiratory infections in the pediatric population. Its mechanisms of action produce immunomodulatory effects that could potentially prevent asthma in early stages of life, act on the reduction of crisis and be a contribution to conventional asthma therapy. This article shows the main evidences in relation to these compounds, the current focus and future development, especially on OM-85.

A structural model of well-being, spontaneity and self-efficacy: Italian validation between adolescents and young adults / Um modelo estrutural entre bem-estar, espontaneidade e autoeficácia: validação italiana entre adolescentes e adultos jovens

Abstract Introduction: The passage from adolescence to young adulthood introduces many challenges and chances aimed at promoting independence, financial self-sufficiency, assumption of responsibilities and separation from parents. Literature shows that in the continuum between these two phases of life, many factors intervene, producing significant differentiations. Methods: This study considered three dimensions - well-being, measured through the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM); spontaneity, measured through the Spontaneity Assessment Inventory-Revised (SAI-R); and self-efficacy, measured through the General Self-Efficacy scale (GSE). The study involved two groups of Italian participants: 495 adolescents, aged between 13 and 19 years, selected at a high school; and 368 young adults, aged between 18 and 30 years, recruited by snowball sampling. Results: Results of confirmatory factor analysis for each instrument in each group indicate the validity of the three instruments for both age groups. No significant differences were found between adolescents and young adults on total or subtotal scores of the CORE-OM, except for the risk factor. Conversely, the mean scores obtained with SAI-R and GSE were very different between adolescents and young adults. Conclusions: The results of path analysis show a significant mediation of spontaneity in the link between self-efficacy and all specific psychological distress domains for adolescents. Instead, there is a significant mediation of spontaneity between self-efficacy and all specific psychological distress domains except the risk domain for young adults.

Resumo Introdução: A transição da adolescência para a idade adulta envolve muitos desafios e oportunidades de promover independência, autossuficiência financeira, assunção de responsabilidades e a saída da casa dos pais. A literatura mostra que, na passagem entre essas duas fases do ciclo vital, muitos fatores podem intervir, gerando mudanças significativas. Métodos: Este estudo considerou três dimensões psíquicas: bem-estar, investigado através do Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM); espontaneidade, investigada através do Spontaneity Assessment Inventory-Revised (SAI-R); e autoeficácia, investigada por meio da escala General Self-Efficacy (GSE). O estudo envolveu dois grupos de participantes italianos: 495 adolescentes com idade entre 13 e 19 anos, selecionados em uma escola de ensino médio; e 368 jovens adultos com idade entre 18 e 30 anos, recrutados por meio de amostragem em bola de neve. Resultados: Os resultados da análise fatorial confirmatória para cada instrumento em cada grupo indicaram a validade dos três instrumentos para as duas faixas etárias. Não foram observadas diferenças significativas entre adolescentes e jovens adultos nos resultados total e subtotal do CORE-OM, exceto pelo fator risco. Por outro lado, os resultados médios obtidos nos instrumentos SAI-R e GSE foram muitos diferentes entre adolescentes e jovens adultos. Conclusões: Os resultados da análise fatorial mostram uma mediação significativa da espontaneidade entre a autoeficácia e todos os domínios das dificuldades psicológicas específicas dos adolescentes. Em contraste, há uma mediação significativa da espontaneidade entre a autoeficácia e todos os domínios específicos das dificuldades psicológicas dos jovens adultos, exceto para o domínio risco.

Sources and distribution of polycyclic aromatic hydrocarbons (PAHs) and organic matter in surface sediments of an estuary under petroleum activity influence, Todos os Santos Bay, Brazil.

The present study evaluated the origin and distribution of polycyclic aromatic hydrocarbons (PAHs) and the organic matter (OM) in the surface sediment of the São Paulo River estuary, Todos os Santos Bay (TSB), Brazil. The samples were collected in the rainy (CP1) and the dry (CP2) seasons. We analyzed the 16 PAHs from the United States Environmental Protection Agency (US EPA) priority pollutant list, total organic carbon (TOC), total nitrogen (N), and stable carbon isotope (δ13C). The total concentration of PAHs ranged from 11.45±1.28 to 1825.35±107.96ngg-1, while TOC ranged from 3.8 to 27.7gkg-1. CP1 showed the highest concentrations for all parameters. The δ13C ratio indicated terrigenous OM (-23.81 to -26.63‰). The TOC/N ratio (C/N) indicated transitional OM (12.32 to 24.39), in addition to the continental origin. The diagnostic ratios of PAHs origin revealed only pyrolytic source, although close to areas with a history of petroleum contamination.

Bacterial extract (OM-85) with human-equivalent doses does not inhibit the development of asthma in a murine model.

BACKGROUND: OM-85 is an immunostimulant bacterial lysate, which has been proven effective in reducing the number of lower airways infections. We investigated the efficacy of the bacterial lysate OM-85 in the primary prevention of a murine model of asthma. METHODS: In the first phase of our study the animals received doses of 0.5µg, 5µg and 50µg of OM-85 through gavage for five days (days -10 to -6 of the protocol), 10 days prior to starting the sensitisation with ovalbumin (OVA), in order to evaluate the results of dose-response protocols. A single dose (5µg) was then chosen in order to verify in detail the effect of OM-85 on the pulmonary allergic response. Total/differential cells count and cytokine levels (IL-4, IL-5, IL-13 and IFN-γ) from bronchoalveolar lavage fluid (BALF), OVA-specific IgE levels from serum, lung function and lung histopathological analysis were evaluated. RESULTS: OM-85 did not reduce pulmonary eosinophilic response, regardless of the dose used. In the phase protocol using 5µg/animal of OM-85, no difference was shown among the groups studied, including total cell and eosinophil counts in BALF, serum OVA-specific IgE, lung histopathologic findings and lung resistance. However, OM-85 decreased IL-5 and IL-13 levels in BALF. CONCLUSIONS: OM-85, administered in early life in mice in human-equivalent doses, does not inhibit the development of allergic pulmonary response in mice.

Stress Distribution Evaluation of the Periodontal Ligament in the Maxillary Canine for Retraction by Different Alveolar Corticotomy Techniques: A Three-dimensional Finite Element Analysis.

AIM: By using the finite element method (FEM), this study aimed to evaluate the effect of different corticotomy formats on the distribution and magnitude of stress on the periodontal ligament (PDL) during retraction of the maxillary canine. MATERIALS AND METHODS: A geometric model of the left hemi-jaw was created from computed tomography scan images of a dry human skull and loads were administered during distalization movement of the canine. Three trials were performed: (1) without corticotomy, (2) box-shaped corticotomy and perforations in the cortical bone of the canine (CVC) and (3) CVC and circular-shaped corticotomy in the cortical bone of the edentulous space of the first premolar. RESULTS: There was no difference in stress distribution among the different corticotomy formats. CONCLUSION: Different corticotomy formats used to accelerate orthodontic tooth movement did not affect stress distribution in the PDL during canine retraction. CLINICAL SIGNIFICANCE: From a mechanical perspective, the present study showed that the stress distribution on the PDL during canine retraction was similar in all the corticotomy formats. When using the Andrews T2 bracket, the PDL presented the highest levels of stress in the middle third of the PDL, suggesting that the force was near the center of resistance. Also, as bone weakening by corticotomies did not influence stress distribution, the surgical procedure could be simplified to a less aggressive one, focusing more on inflammatory cellular stimulation than on bone resistance. A simpler surgical act could also be performed by most orthodontists in their practices, enhancing postoperative response and reducing patient costs.

Clinical and Immunological Benefits of OM-85 Bacterial Lysate in Patients with Allergic Rhinitis, Asthma, and COPD and Recurrent Respiratory Infections.

PURPOSE: The aim of this study was to evaluate the efficacy of OM-85 in reducing the incidence of respiratory tract infections (RTIs) in patients with allergic rhinitis, asthma, or chronic obstructive pulmonary disease (COPD), and its effect on immunological parameters, namely serum and secretory IgA levels. METHODS: This was an open-label, prospective, sequential study which included 84 consecutive patients aged 16-65 years, who presented with recurrent (three or more) respiratory infections during the year prior to study entry. In the first year of the study, patients received standard optimized care (SOC), according to their underlying disease condition (asthma, allergic rhinitis, or COPD). In the following year, patients received treatment with OM-85 oral bacterial lysate (one 7 mg capsule daily for ten consecutive days per month, for 3 months), with a 6-month follow-up. Medical history, clinical symptoms, serum, and secretory IgA levels, and the number of infections and exacerbations were evaluated before and after treatment. RESULTS: There was a decrease in the total number of RTIs before the OM-85 treatment period (SOC only) compared to the year before the study start [69/266 (corresponding to a 74 % reduction)] and an additional decrease [38/69 (corresponding to a 45 % reduction)] after OM-85 treatment; p < 0.05. There was also a significant reduction in the total number of exacerbations related to the patients' underlying medical conditions, which decreased from 55 to 35 during OM-85 (+SOC) treatment, corresponding to a reduction of 36 %. In addition, an increase in serum and secretory IgA levels which coincided with the administration of OM-85 was observed. CONCLUSIONS: Our results showed the clinical benefits of OM-85 in reducing RTIs and exacerbations of the underlying medical condition, in patients with allergic rhinitis, asthma, or COPD.

Influence of operating microscope in the sealing of cervical perforations.

CONTEXT: Accidental root canal perforations are among the main complications of endodontic treatment. AIM: This study evaluated the influence of operating microscope (OM) in the marginal adaptation of mineral trioxide aggregate (MTA) (Angelus(®)) and glass ionomer (Vitremer) inserted into cervical perforations. MATERIALS AND METHODS: Perforations were made in the cervical third of the buccal wall of the root canal in mandibular incisors. Next, the teeth were divided into four groups (N = 10): MG - MTA without OM; VG - Vitremer without OM; MOMG - MTA with OM; VOMG - Vitremer with OM. The perforations were sealed according to the group and the teeth were prepared for analysis by confocal laser scanning microscope. Images of perforation region (1,024×) were made and the gap presented by the materials was measured using the Image J program. LEXT OLS4100 three dimensional (3D) measuring laser microscope measured the volumetric misfit. Data of gap were analyzed by Kruskal-Wallis and Dunn's tests. Analysis of variance (ANOVA) and Tukey's tests compared the volumetric misfits. RESULTS: The results showed lower volume and gap in the interface dentin/material in VOMG compared to the other groups (P < 0.05). CONCLUSION: The use of OM improved the quality of cervical perforations sealed with Vitremer, being indicated in clinical situations of iatrogenic cervical perforations.

X-ray crystal structure of the passenger domain of plasmid encoded toxin(Pet), an autotransporter enterotoxin from enteroaggregative Escherichia coli (EAEC).

Autotransporters (ATs) represent a superfamily of proteins produced by a variety of pathogenic bacteria, which include the pathogenic groups of Escherichia coli (E. coli) associated with gastrointestinal and urinary tract infections. We present the first X-ray structure of the passenger domain from the Plasmid-encoded toxin (Pet) a 100 kDa protein at 2.3 Å resolution which is a cause of acute diarrhea in both developing and industrialized countries. Pet is a cytoskeleton-altering toxin that induces loss of actin stress fibers. While Pet (pdb code: 4OM9) shows only a sequence identity of 50% compared to the closest related protein sequence, extracellular serine protease plasmid (EspP) the structural features of both proteins are conserved. A closer structural look reveals that Pet contains a ß-pleaded sheet at the sequence region of residues 181-190, the corresponding structural domain in EspP consists of a coiled loop. Secondary, the Pet passenger domain features a more pronounced beta sheet between residues 135 and 143 compared to the structure of EspP.

Association of a genetic variant of carnitine palmitoyltransferase 1A with infections in Alaska Native children.

OBJECTIVE: To evaluate whether the arctic variant (c.1436C→T) of carnitine palmitoyltransferase type 1A (CPT1A) is associated with a higher incidence of adverse health outcomes in Alaska Native infants and children. STUDY DESIGN: We evaluated health measures from birth certificates (n = 605) and Alaska Medicaid billing claims (n = 427) collected from birth to 2.5 years of age for a cohort of Alaska Native infants with known CPT1A genotype. To account for geographic variations in gene distribution and other variables, data also were evaluated in cohorts. RESULTS: When analysis was restricted to residents of nonhub communities in Western and Northern Alaska, children homozygous for the arctic variant experienced more episodes of lower respiratory tract infection than did heterozygous or noncarrier children (5.5 vs 3.7, P = .067) and were more likely to have had otitis media (86% vs 69%, 95% CI 1.4-8.9). Associations were weaker for more homogeneous cohorts. CONCLUSIONS: The association of the arctic variant of CPT1A with infectious disease outcomes in children between birth and 2.5 years of age suggests that this variant may play a role in the historically high incidence of these health outcomes among indigenous Arctic populations; further studies will need to assess if this association was confounded by other risk factors.