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Background: Rotavirus (RV) is the leading cause of acute gastroenteritis (GE) among infants and young children worldwide. However, little is currently known concerning the specific burden of RVGE in Central and Eastern Europe (CEE). This study was undertaken to asses the burden of RVGE among children aged

Aim: A randomized, double-blind study was conducted to evaluate whether use of protein hydrolysate-based preterm formulas in infants with an atopic predisposition helps prevent the development of allergic diseases. Methods: Preterm infants (n= 122) with at least one first-degree relative (parent or sibling) with allergic disease were randomly assigned to receive an extensively or partially hydrolysed preterm formula (intervention groups) or a standard preterm formula until 4 to 5 mo of age. Infants whose parents preferred that they be breastfed received their mothers' fortified breast milk. Results: Intention-to-treat analysis showed that the overall incidence of allergic diseases did not significantly differ between groups at both 4–5 and 12 mo of age. However, by 12 mo, use of the extensively hydrolysed versus the standard preterm formula had significantly reduced the risk of atopic dermatitis. At 4–5 and 12 mo, there was a significantly increased risk of non-acceptance of the extensively hydrolysed formula compared with the other formulas. Conclusions: This study failed to show that extensively or partially hydrolysed preterm formulas in comparison with a standard preterm formula reduced the overall incidence of allergic diseases in infants at high risk for atopic disease. However, use of the extensively hydrolysed compared with a standard preterm formula significantly reduced the incidence of atopic dermatitis observed at 12 mo. Infants who received extensively hydrolysed formulas were at increased risk for intervention discontinuation for any reason, particularly non-acceptance of the formula. Because of the small number of patients eligible for this analysis, these results should be interpreted with caution.

The degree of diversity of cocirculating human rotavirus wild-type strains is high. This article reviews the occurrence and frequency of rotavirus types in European children younger than 5 years of age during the past 10-15 years. To enable greater understanding of the overall epidemiologic situation, rotavirus types found in animals in Europe are described. In addition, rotavirus types occurring in children outside Europe are considered. Taken together, these data provide an essential background to the development of rotavirus vaccines. The different concepts of immunization with the 2 main rotavirus candidate vaccines are briefly discussed, and their potential impact on the epidemiology of cocirculating rotavirus wild-type viruses is considered. A case is made for comprehensive surveillance of cocirculating human rotavirus types in Europe after the implementation of rotavirus vaccination.

Probiotics, defined as microbial cell preparations or components of microbial cells that have a beneficial effect on the health and well being of the host, have traditionally been used to treat and prevent a variety of infections. Beneficial effects of probiotics in acute infectious diarrhea in children seem to be: (i) moderate; (ii) strain-dependent; (iii) dose dependent; (iv) significant in watery diarrhea and viral gastroenteritis, but non-existent in invasive, bacterial diarrhea; and (v) more evident when treatment with probiotics is initiated early in the course of disease. Three large, randomized controlled trials (RCTs) provide evidence of a very modest effect (statistically significant, but of questionable clinical importance) of some probiotic strains (Lactobaccillus GG, Lactobaccillus reuteri, Bifodobacterium lactis) on the prevention of community-acquired diarrhea. We have found conflicting evidence from four RCTs on the efficacy of Lactobacillus GG and B. bifidum and Streptococcus thermophilus in the prevention of nosocomial diarrhea in children. Two RCTs in children provide evidence of a moderate beneficial effect of Lactobacillus GG in the prevention of antibacterial-associated diarrhea (AAD), but results in adults are conflicting. Data on the efficacy of other probiotic strains in AAD in children are very limited. In conclusion, to date, the most extensively studied and best documented clinical application of probiotics in children is for the treatment of acute watery diarrhea of rotaviral or presumably viral etiology. Studies documenting effects in other types of diarrheal diseases in children are limited, although some preliminary results are promising. The effects of different probiotic microorganisms are not equal. Only very few probiotic strains have been tested rigorously in RCTs. Many questions remain to be answered. Future clinical trials should evaluate carefully selected, precisely defined probiotic strains and address clinically important endpoints.

Background: This review was designed to assess the evidence from randomized controlled trials on effects of probiotics in the treatment and prevention of acute infectious diarrhea in infants and children. Methods: A systematic review of published, randomized, double-blind, placebo-controlled trials on probiotics in the treatment or prevention of acute diarrhea defined as >3 loose or watery stools per 24 hours in infants and children. Results: The use of probiotics as compared with placebo was associated with a significantly reduced risk of diarrhea lasting >3 days. The pooled estimate risk was 0.43 (95% CI, 0.34– 0.53) with a fixed-effect model, and remained significant in a random-effect model (0.40; 95% CI, 0.28–0.57). Only Lactobacillus GG showed a consistent effect. Probiotics significantly reduced the duration of diarrhea when compared with placebo, particularly in rotaviral gastroenteritis—the pooled, weighted, mean difference (WMD) assuming the random-effect model was �20.1 hours (95% CI, �26.1 to �14.2) and �24.8 (95% CI, �31.8 to �17.9) respectively. A meta-analysis of the prevention studies was not feasible because of significant clinical and statistical heterogeneity. Conclusions: There is evidence of a clinically significant benefit of probiotics in the treatment of acute infectious diarrhea in infants and children, particularly in rotaviral gastroenteritis. Lactobacillus GG showed the most consistent effect, although other probiotic strains may also be effective. Further research is needed. Clinical and statistical heterogeneity of the prophylactic interventions preclude drawing firm conclusions about the efficacy of probiotics in preventing acute gastroen

Live rotavirus vaccine candidates representing VP7 serotypes 1, 2, 3 or 4 derived by reassortment between bovine UK rotavirus and human rotavirus strains D, DS-1, P or ST3 were evaluated for safety and immunogenicity in adults, children and infants. Infection was defined by evidence of rotavirus shed in stools or a 4-fold or greater increase in serum rotavirus-specific IgA or IgG ELISA or plaque reduction neutralization antibody. A single oral dose (10 5.3 or 10 5.8 pfu) of reassortant virus was well tolerated and infected most infants: 10/20 (50%) by D×UK; 9/11 (82%) by DS-1×UK; 8/10 (80%) by P×UK and 13/14 (93%) by ST3×UK. All 14 infants given two doses of D×UK were infected. These findings demonstrating satisfactory levels of attenuation, safety, infectivity and immunogenicity of each reassortant in infants warrant additional studies of a candidate vaccine containing these four strains.

The use of probiotics, once discussed primarily in the context of alternative medicine, is now entering mainstream medicine. However, only a few of the potential health benefits attributed to probiotics have been confirmed in well-designed, well-conducted, randomized, controlled trials. This is especially true in the pediatric population. We review here the available evidence on efficacy of probiotics in children in the prevention and treatment of gastrointestinal diseases. Although we restrict our analysis to the pediatric age, whenever potentially relevant information is available only from adult studies, they are examined as well. Probiotics have been most extensively studied in the treatment of diarrheal diseases, where their efficacy can be considered well established. Studies documenting effects in other childhood gastrointestinal illnesses are few, although some preliminary results are promising. Furthermore, only a limited number of probiotic strains have been tested, and, as the effects of different probiotic microorganisms are not equivalent, results cannot be generalized. Thus, at present, we have some positive certainties, lots of exciting promises and many unanswered questions.

Two new rotavirus vaccines are expected to be introduced in the European Union (EU) in coming years. A human rotavirus vaccine has already been licensed in several countries worldwide, and a pentavalent bovine vaccine has been submitted for licensure in the United States and the EU. Few data exist on the burden of rotavirus disease and its associated costs within the EU. To estimate the burden of rotavirus disease in the EU, we adapted a model based on the approach developed by the Centers for Disease Control and Prevention to the European situation and applied it to recent population and mortality data from European countries. Country-specific estimates were added to obtain a global estimate of rotavirus episodes treated at home, clinic visits, hospitalization and death. We estimate that 3.6 million episodes of rotavirus disease occur annually among the 23.6 million children younger than 5 years of age in the EU. Every year, rotavirus accounts for 231 deaths, >87,000 hospitalizations and almost 700,000 outpatient visits. Rotavirus disease constitutes a large public health burden in the EU. Except for deaths, the burden of disease is not dissimilar to that in the developing world. Country-specific studies are required to more accurately understand the burden of disease caused by rotavirus. With the introduction of new rotavirus vaccines in sight, rotavirus gastroenteritis may be regarded as the single most frequent vaccine-preventable disease among children in the EU.

Although not currently recommended, dioctahedral smectite (smectite) is commonly used to treat acute infectious diarrheal in many countries. To evaluate systematically the effectiveness of smectite in treating acute infectious diarrhea in children. Using medical subject headings and free language terms, the following electronic databases were searched for studies relevant to acute infectious diarrhea and smectite: medline, embase, cinahl and the cochrane library; additional references were obtained from reviewed articles. Only randomized controlled trials were included. Nine randomized controlled trials (1238 participants) met the inclusion criteria. Combined data from six randomized controlled trials showed that smectite significantly reduced the duration of diarrhea compared with placebo. The pooled weighted mean difference was (22,7 h, 95% CI: 24,8 to 20,6) with a fixed model and remained significant in a random effect model (24,4 h, 95% CI: 29,8 to 19,1). The chance of cure on intervention day 3 was significantly increased in the smectite vs. the control group (RR 1,64, 95% CI: 1,36–1,98; number needed to treat 4,95% CI: 3–5). Adverse effects were similar in both groups. Smectite may be a useful adjunct to rehydration therapy in treating acute pediatric gastroenteritis. However, the results of this meta analysis should be interpreted with caution as most of the included studies had important limitations. Cost effectiveness analyses should be undertaken before routine pharmacological therapy with smectite is recommended.Key words: dioctahedral smectite, meta_analysis, acute infectious diarrhea, children.

Summary Background : Antibiotic-associated diarrhoea occurs in up to 30% of patients who receive antibiotics but can be prevented with probiotics. Aim : To systematically evaluate the effectiveness of Saccharomyces boulardii in preventing antibiotic-associated diarrhoea in children and adults. Methods : Using medical subject headings and free-language terms, the following electronic databases were searched for studies relevant to antibiotic-associated diarrhoea and S. boulardii: MEDLINE, EMBASE, CINAHL and The Cochrane Library. Additional sources were obtained from references in reviewed articles. Only randomized-controlled trials were considered for study inclusion. Results : Of 16 potentially relevant clinical trials identified, five randomized-controlled trials (1076 participants) met the inclusion criteria for this systematic review. Treatment with S. boulardii compared with placebo reduced the risk of antibiotic-associated diarrhoea from 17.2% to 6.7% (RR: 0.43; 95% CI: 0.23–0.78; random effect model). The number needed to treat to prevent one case of antibiotic-associated diarrhoea was 10 (95% CI: 7–16). No side-effects were reported. Conclusions : A meta-analysis of data from five randomized-controlled trials showed that S. boulardii is moderately effective in preventing antibiotic-associated diarrhoea in children and adults treated with antibiotics for any reason (mainly respiratory tract infections). For every 10 patients receiving daily S. boulardii with antibiotics, one fewer will develop antibiotic-associated diarrhoea.

Streszczenie W dniach 24 lutego i 24 marca 2011 roku w Warszawie odbyly sie dwa spotkania robocze polskiej Grupy Ekspertow* pod wspolnym tytulem „Nowe mozliwości stosowania pediatrycznych szczepionek zawierających DTPa”. Podczas obu konferencji dyskutowano nad dotychczasowymi wynikami badan klinicznych i praktycznych doświadczen opublikowanych w piśmiennictwie, poświeconych szczepionkom skojarzonym zawierającym komponenty DTPa, ze szczegolnym uwzglednieniem szczepionek piecio- i sześciowalentnych. W tematycznych prezentacjach czlonkow Grupy Ekspertow przedstawiono szereg zagadnien: aspekty immunogenności i bezpieczenstwa szczepionek wysoce skojarzonych, ich stosowanie w pediatrycznych grupach ryzyka oraz aktualną praktyke i schematy stosowania w programach szczepien ochronnych krajow Unii Europejskiej. Dyskutowano takze nad zagadnieniami stosowania szczepionek wysoce skojarzonych w kontekście danych tworzących medycyne opartą na faktach, związanych z krytycznym spojrzeniem na przedstawione dotychczas wyniki stosowania szczepionek skojarzonych zawierających DTPa. Przedstawiony ponizej tekst stanowiska czlonkow Grupy Ekspertow powstal w wyniku uzyskania konsensusu, po uwzglednieniu uwag, propozycji i akceptacji ostatecznego tekstu przez uczestnikow obu spotkan.

Users of clinical practice guidelines and other recommendations need to know how much confidence they can place in the recommendations. Systematic and explicit methods of making judgments can reduce errors and improve communication. We have developed a system for grading the quality of evidence and the strength of recommendations that can be applied across a wide range of interventions and contexts. In this article we present a summary of our approach from the perspective of a guideline user. Judgments about the strength of a recommendation require consideration of the balance between benefits and harms, the quality of the evidence, translation of the evidence into specific circumstances, and the certainty of the baseline risk. It is also important to consider costs (resource utilisation) before making a recommendation. Inconsistencies among systems for grading the quality of evidence and the strength of recommendations reduce their potential to facilitate critical appraisal and improve communication of these judgments. Our system for guiding these complex judgments balances the need for simplicity with the need for full and transparent consideration of all important issues.