***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 
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    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 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 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 . The trial began in July 1997 and ended in April 1999 . RESULTS The number ( mean + /- SD ) of ARTIs was 5.04 + /- 1.99 ( median , 5.0 ) in the OM-85 BV group vs 8.0 + /- 2.55 ( median , 8.0 ) in the placebo group , with a mean difference of - 2.96 ( 95 % confidence interval [ CI ] , - 4.22 to - 1.7 ) . The number of antibiotic courses was 2.46 + /- 2.08 ( median , 1.5 ) in the treatment group vs 4.46 + /- 2.08 ( median , 4.0 ) in the control group , a difference of - 2.0 ( 95 % CI , - 3.14 to - 0.86 ) . The total duration of ARTIs was 35.23 + /- 17.64 days ( median , 30.5 days ) in the OM-85 BV group vs 60.75 + /- 25.44 days ( median , 55.0 days ) in the placebo group , ie , a difference of - 25.52 days ( 95 % CI , - 37.56 to - 13.47 days ) , p < 0.001 by Student 's t test and Mann-Whitney U test for all the items . Four patients in the OM-85 BV group had five adverse events . Only one episode of skin rash was related to the medication intake . Six patients in the control group had six adverse events . CONCLUSIONS OM-85 BV had a preventive effect on ARTI in the susceptible children for 12 months with an important reduction on  the  antibiotic requirements and the number of days of suffering ARTIs OBJECTIVE Recurrent upper respiratory tract infections ( URTIs ) are common illnesses in young children . As the immunoactive bacterial extract OM-85 has been shown to prevent these infections in both adults and children , the aim of the present trial was to investigate further its efficacy and safety in infection-prone children . METHODS This is a r and omized , double-blind , placebo-controlled , multicenter study with OM-85  in 232 patients aged 36 to 96 months with recurrent URTIs . Treatment was one capsule daily during month 1 and during 10 days in months 3 to 5 . URTI was defined by the presence of at least two of the following : rhinitis , pharyngitis , cough , hoarseness , temperature > or = 38.5 degrees C , or URTI-related prescription of an antibiotic . RESULTS OM-85-treated patients had a lower rate of URTIs ( p < 0.05 ) . The cumulated difference in URTIs between the two groups reached - 0.40 URTIs per patient in 6 months , corresponding to a 16 % reduction in the active-treatment group with respect to placebo . The largest difference was observed in the patients having had three or more URTIs during the study period ; odds ratios for three or more URTIs were 0.51 ( 95 % confidence interval , 0.29 to 0.91 ) and 0.65 ( 95 % confidence interval , 0.37 to 1.11 ) after 5 months and 6 months , respectively . The difference between OM-85 and placebo was independent of age but was more important in patients reporting a larger number of URTIs in the previous year . Patients ' global assessment showed improvement in comparison to the previous season in the majority of the cases ( OM-85 , 78.4 % of cases ; placebo , 75.5 % ) ; however , there were more cases reporting worsening with placebo ( 6.4 % vs 0.9 % ; p = 0.05 ) . CONCLUSIONS OM-85 treatment significantly reduced the rate of URTIs , particularly in children with a history of frequent URTIs .  Safety and tolerance of test medication were good , comparable to placebo A r and omized , double blind , placebo-controlled clinical trial was performed in 423 children attending day-care centers to assess whether stimulating nonspecific immunity would reduce the incidence of recurrent infections . The drug used for the trial ( Imocur ) is an extract obtained from eight different species of bacteria . At the end of the total follow-up period ( 3 months with treatment and 4.5 months without ) , the risk for > or = 4 episodes of upper respiratory infections was not significantly lower in the treated group than in the placebo group ( 26.7 % vs. 33.8 % , relative risk , 0.79 ; 95 % confidence interval , 0.59 to 1.06 ) . In an exploratory analysis limited to the 3-month treatment period , however , we observed a 48 % reduction in the risk of presenting > or = 3 episodes of upper respiratory infections : 9.5 % vs. 18.3 % , respectively , in the treatment group and the placebo group ( relative risk , 0.52 ; 95 % confidence interval , 0.31 to 0.86 ) . Similar results were found for the risk of > or = 1 episode of gastroenteritis . We also observed a strong correlation between the drug efficacy and age ; this observation is coherent with the underlying pathophysiologic model in which the immune system matures with age 94 children suffering from frequent infections of the respiratory tract and of the ear , nose and throat were treated under double-blind conditions with either a bacterial lysate ( n = 45 ) or a placebo  ( n = 49 ) . During the 6 months of the trial both treatments brought about a significant decrease in the incidence and duration of these infections as well as in the duration of concomitant antibiotherapy in comparison to the corresponding prior 6-month reference period . As these positive results recorded under the bacterial lysate and the 
    Output:
    
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