***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: The efficacy of Broncho-Vaxom/Imocur ( OM-85 BV ) , an orally administered lyophilized bacterial extract , for recurrent respiratory and ear , nose and throat ( ENT ) infections was evaluated in 116 children aged 6 months to 19 years by comparing its activity in 61 children with that of a placebo in 55 children . The study was r and omized , double-blind , and comprised a 90-day treatment period followed by a 90-day follow-up period without test drugs . Over the 180 days , 39.5 % of patients taking OM-85 BV  remained free from infection compared with 16.5 % on placebo ( p less than 0.01 ) . 44 % on OM-85 BV did not need antibiotics  compared with 23.5 % on placebo ( p less than 0.05 ) . These differences were even greater in the subgroup of children aged 6 years and less ( 34 vs. 3.5 % for the absence of infections , p less than 0.01 and 37 vs. 10 % for the need of antibiotics , p less than 0.05 ) . Tolerance to OM-85 BV was excellent , and laboratory investigations showed no abnormalities attributable to this product . This work confirms that the immunomodulator OM-85 BV is an effective immunotherapy for recurrent respiratory and ENT infections in children Using a cohort-based design and r and om enrollment , the relation of various risk factors to acute otitis media , respiratory infection and wheezy bronchitis was studied in 2512 children from the fetal period to the age of two years . The complex interrelations of the risk factors with each other were separated out by multivariate analysis , and the confounding effects of antenatal parameters were also st and ardized . Acute otitis media with effusion ( AOME ) , as demonstrated by myringotomy , was analyzed as a specific subgroup of acute otitis media ( AOM ) . Day care in local authority nursery was the major risk factor for both types of acute otitis media . The odds ratio ( OR ) for such children becoming ' otitis-prone ' ( greater than or equal to 3 episodes of AOME ) was 1.8 ( 95 % confidence interval , 1.4 - 2.2 ) . Short duration of breastfeeding involved another significant risk of recurrent respiratory infections and otitis media , the OR for AOME being 1.5 ( 1.1 - 2.0 ) and that for recurrent respiratory infection 1.3 ( 1.1 - 1.6 ) . Allergy and family day care were also significantly associated with infective parameters , but to a lesser extent . The risk factors for wheezy bronchitis were the same as for infections , indicating that wheezy bronchitis is closely related to infections In a 6-month placebo-controlled double-blind multicenter study in 230 patients with recurrent respiratory tract infections , the therapeutic efficacy of Broncho-Vaxom was demonstrated by comparing infection incidence and severity as well as antibacterial medication . Investigators and patients agreed that Broncho-Vaxom exerts a significantly greater protective effect than placebo . Reports of side effects were more frequent with placebo as compared to Broncho-Vaxom BACKGROUND Recurrent acute respiratory tract infections ( RARTIs ) in children are related to IgG subclass deficiencies . The aim of the trial was to evaluate the effect of OM-85 BV in the number of RARTIs as well as in the IgG subclass levels . METHODS This was a r and omized , double-blind , placebo-controlled clinical trial . Patients of ages three to six years , having three or more documented ARTIs during the last six months with subnormal IgG subclass levels were included . Patients took either one capsule of OM-85 BV ( 3.5 mg ) or placebo orally every day for ten consecutive days per month during three consecutive months . Patients were followed three further months without drug intake . IgG subclass levels were determined before and after treatment . RESULTS IgG4 levels diminished after the OM-85 BV treatment ( -3 [ -8.0 , -1.0 ] median difference [ 95 % CI ] p < 0.05 by Wilcoxon test ) . No other significant changes in IgG subclasses were observed . After six months the patients in the OM-85 BV group ( n = 20 ) experienced 2.8 1.4 ( mean SD ) ARTIs , while the patients in the placebo group ( n = 20 ) suffered 5.2 1.5 ARTIs ( -2.4 [ 3.3 , -1.5 ] mean difference [ 95 % CI ] p < 0.001 by Student 's t test ) . Three patients with OM-85 BV had gastrointestinal events related to drug administration , as well as three placebo patients . CONCLUSION This study demonstrated the clinical benefit of OM-85 BV in patients suffering from RARTIs and subnormal levels of IgG subclasses . This trial opens new perspectives in the research of the mechanism of action of OM-85 BV BACKGROUND Acute respiratory tract infections ( ARTIs ) are among the main causes of morbidity and mortality in children . The bacterial extract OM-85 BV has shown some protective effect for ARTIs in preschool children and a reduction in exacerbations of chronic bronchitis in adults . OBJECTIVES This trial reports results of a double-masked , placebo-controlled , parallel-group clinical study that assessed the efficacy and tolerability of OM-85 BV in the prevention of ARTIs in school girls living in an orphanage . METHODS Two hundred girls ( age range , 6 to 13 years ) living in an orphanage entered the trial . Participants were r and omly allocated to receive either OM-85 BV or placebo for 10 consecutive days a month for 3 consecutive months . Patients were followed up for 6 months , including the administration period . The trial began in September 1996 and finished in March 1997 . Primary end points were the type and number of infections . Secondary end points included when an infection occurred , time to clinical cure , severity of infection , absenteeism from school due to an ARTI , number of antibiotics or other drugs prescribed , and duration of concomitant drug treatment . RESULTS During the trial , patients in the OM-85 BV group experienced 143 ARTIs ( 135 upper ARTIs and 8 otitis episodes ) and patients in the placebo group experienced 299 ARTIs ( 273 upper ARTIs , 1 lower ARTI , and 25 otitis episodes ) . The median number of ARTIs was 1.0 ( 0.0 , 3.0 ; 5th percentile , 95th percentile ) in the OM-85 BV group compared with 3.0 ( 2.0 , 4.0 ; 5th percentile , 95th percentile ) in the placebo group . This difference was statistically significant ( P < 0.001 ) . Participants who received OM-85 BV also showed significantly better results ( P < 0.001 ) than participants who received placebo in terms of median duration of illness , median number of missed school days due to an ARTI , median number of antibiotic and drug courses , and median duration of concomitant treatment . There were significant differences ( P < 0.05 ) in severity of ARTIs during month 4 of the trial , with patients receiving OM-85 BV showing less severe ARTIs than patients receiving placebo and shorter mean time to clinical cure from the second month to the fourth month . No adverse events related to the trial medications were reported . CONCLUSIONS OM-85 BV had a preventive effect on ARTIs in the school girls , with a reduction in the antibiotic requirements and the duration of ARTIs . Future studies are needed to further explore the role of OM-85 BV in the prevention of ARTIs The role of repeated infections early in life in the development of childhood asthma and allergies has not been clarified . The aim of this study was to investigate the effect of repeated episodes of fever and antibiotic treatments during the first years of life on the prevalence of asthma , bronchial hyperresponsiveness ( BHR ) , and atopy at school age in a representative population . R and om sample s of schoolchildren aged 5 - 7 yrs ( n=7,545 ) and 9 - 11 yrs ( n=7,498 ) were studied using the International Study of Asthma and Allergies in Childhood ( ISAAC ) phase II protocol . To assess the prevalence of disease and early childhood exposures , parental question naires were administered ( response rates 82.2 % and 85.3 % , respectively ) . In addition , children underwent skin prick tests , hypertonic saline challenge and blood sampling for the measurement of serum immunoglobulin (Ig)E. Repeated episodes of fever and antibiotic treatment in early life were strongly associated with the prevalence of asthma ( odds ratio (OR)=7.95 ; 95 % confidence interval ( CI ) 6.02 - 10.50 ) and current wheeze at school age . Within asthmatic children the number of fever episodes and antibiotic courses were strongly inversely related to the prevalence of atopy ( OR=0.25 ; 95 % CI 0.11 - 0.54 for skin test reactivity ) and BHR ( OR=0.31 ; 95 % CI 0.10 - 0.92 ) . Furthermore , asthmatic children with recurrent early childhood infections were at a lower risk of being symptomatic at school age . When considering atopic and nonatopic asthmatic children separately , the highest risk of asthma with repeated early childhood infections was found for nonatopic asthma ( OR=24.29 ; 95 % Cl 11.86 - 49.76 ) . These findings suggest that a subgroup of children with a triggering or inducing of asthmatic symptoms through repeated early childhood infections exists within the " asthma syndrome " which has a better prognosis and is less related to the atopic phenotype A 6-month double-blind , prospect i ve , r and omized , placebo-controlled trial was conducted to establish the safety and efficacy of OM-85-BV in the treatment of  subacute sinusitis  and in the following prevention of the respiratory tract infections in 56 children from 18 months to 9 years of age . In the subacute phase of the sinusitis the patients were given one OM-85-BV capsule ( 3.5 mg of bacterial extracts ) ( n = 26 ) or placebo ( n = 30 ) , daily for ten days ; additionally both groups took amoxicillin/clavulanate 40/10 mg/kg daily in three divided doses for 21 days . For the following two months the patients took one OM-85-BV capsule or placebo , ten days a month . In the subacute phase the OM-85-BV group of patients improved sooner ( 5.56 + /- 4.98 vs 10 + /- 8.49 days ) and had a shorter convalescence ( 15.38 + /- 8.91 vs 20.28 + /- 7.17 days ) . During the six month follow-up the patients in the OM-85-BV group had a lower number of infections ( 1.56 + /- 0.3 vs 2.22 + /- 0.43 ) and required a lower number of drug treatments ( 1.47 + /- 0.32 vs 1.94 + /- 0.42 ) . One patient treated with OM-85-BV presented a mild rash which disappeared three days after the drug discontinuation . We conclude that OM-85-BV is safe at pediatric ages , as well as accelerates the cure and improvement of subacute sinusitis while it lowers the incidence of respiratory infections The effect of a bacterial extract orally administered to 20 children with recurrent infections of the upper respiratory tract , was investigated in a double-blind study . The composition of the peripheral blood mononuclear cells ( T and B-lymphocytes , monocytes ) and some of their biochemical properties ( 5'-nucleotidase , beta-N-acetyl-glucosaminidase and non-specific esterase ) were unaffected . In contrast , the allogeneic mixed lymphocyte reaction was significantly increased in patients treated with the bacterial extract . In the treated group the number of infectious episodes decreased significantly and the clinical response correlated positively with the mixed lymphocyte reaction . These findings suggest that the bacterial extract has the capacity of restoring depressed immune functions by acting through the gut-associated lymphoid tissue BACKGROUND Acute respiratory tract infections ( ARTIs ) are among the main causes of morbidity and mortality in children . The bacterial extract OM-85 BV ( bronchovaxom ) has shown protective effect for ARTIs on children . We report a double-blind , placebo-controlled , parallel , prospect i ve clinical trial to assess the safety and efficacy of two courses of OM-85 BV in the prevention of ARTIs in susceptible children during 12 months . METHODS Fifty-four susceptible children from 1 to 12 years of age living in the metropolitan area of Chihuahua City were selected . They were r and omized to receive either OM-85 BV or placebo ( one capsule a day for 10 days a month for 3 consecutive months ) at the beginning of the trial and 6 months later with the same schedule . Patients were followed up for 12 months , including the administration period . 
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The results of this review were also positive for the active treatment regarding the secondary variables , which were represented by the number of patients with at least one RTI and the mean number of RTIs .
Conclusions This meta- analysis shows , as observed in several individual trials , that the population treated with OM-85 BV had significantly and consistently fewer cases of recurrent RTIs .
The data suggest that the effect is greater in patients at increased risk of recurrent RTIs