for the Treatment of Acute Diarrhea in Children: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

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chloramphenicol 1 infectiousdiseasesdrugs
diarrhea 80 infectiousdiseases
streptomycin 1 infectiousdiseasesdrugs
tetracycline 1 infectiousdiseasesdrugs

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chloramphenicol 6674 these bacterial strains are derived from their resistance to diverse antibiotics: O/C is resistant to chloramphenicol , SIN to neomycin and streptomycin, N/R to novobiocin and rifampin, and T to tetracycline [[13]].The
streptomycin 6711 from their resistance to diverse antibiotics: O/C is resistant to chloramphenicol, SIN to neomycin and streptomycin , N/R to novobiocin and rifampin, and T to tetracycline [[13]].The primary outcome measures were duration
tetracycline 6766 resistant to chloramphenicol, SIN to neomycin and streptomycin, N/R to novobiocin and rifampin, and T to tetracycline [[13]].The primary outcome measures were duration of diarrhea, stool frequency after intervention, and
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diarrhea 847 Manuel.Plomer@sanofi.comPublication date (epub): 8/2018Publication date (collection): 8/2018AbstractAcute diarrhea is a burdensome disease with potentially harmful consequences, especially in childhood. Despite its
diarrhea 1063 use in clinical practice, the efficacy of the probiotic Bacillus clausii in treating acute childhood diarrhea remains unclear. Our objective was to systematically review the efficacy of Bacillus clausii in the
diarrhea 1201 objective was to systematically review the efficacy of Bacillus clausii in the treatment of acute childhood diarrhea . The following electronic databases were systematically searched up to October 2017: MEDLINE (via PubMed/OVID),
diarrhea 1758 Data arising from pooled analysis showed that Bacillus clausii significantly reduced the duration of diarrhea (mean difference = −9.12 h; 95% confidence interval [CI]: −16.49 to −1.75, p = 0.015), and the
diarrhea 2137 frequency after Bacillus clausii administration compared with the control group (mean difference = −0.19 diarrhea l motions; 95% CI: −0.43 to −0.06, p = 0.14). Bacillus clausii may represent an effective therapeutic
diarrhea 2277 −0.06, p = 0.14). Bacillus clausii may represent an effective therapeutic option in acute childhood diarrhea , with a good safety profile.1. IntroductionDiarrhea refers to the abrupt onset of three or more loose
diarrhea 2445 to the abrupt onset of three or more loose or liquid stools per day [[1]]. More specifically, acute diarrhea is defined as an abnormally frequent discharge of semi-solid or fluid fecal matter from the bowel, lasting
diarrhea 2630 matter from the bowel, lasting less than 14 days [[2]]. Although it is a preventable disease, acute diarrhea remains a major cause of morbidity and mortality in children worldwide, resulting in 525,000 deaths
diarrhea 2877 years. Most of these mortalities occur in developing countries [[1]]. Other direct consequences of diarrhea in children include growth faltering, malnutrition, and impaired cognitive development [[3]]. Acute
diarrhea 2986 in children include growth faltering, malnutrition, and impaired cognitive development [[3]]. Acute diarrhea in children is caused by a wide range of pathogens—including viral, bacterial, and protozoal pathogens—which
diarrhea 3260 challenge [[4]].Currently, the World Health Organization (WHO) recommends treatment of acute childhood diarrhea with oral rehydration salts (ORS) and continued feeding for the prevention and treatment of dehydration,
diarrhea 3450 treatment of dehydration, as well as zinc supplementation to shorten the duration and severity of the diarrhea l episode [[1]]. Probiotics are living micro-organisms that, upon ingestion in certain numbers, exert
diarrhea 4185 adult subjects found Bacillus clausii to be effective and safe in the treatment and prevention of acute diarrhea [[10],[11]]. In a prospective, Phase II clinical trial of Bacillus clausii in 27 adult patients with
diarrhea 4301 [[10],[11]]. In a prospective, Phase II clinical trial of Bacillus clausii in 27 adult patients with acute diarrhea , the mean ± standard deviation (SD) duration of diarrhea decreased from 34.81 ± 4.69 min at baseline
diarrhea 4359 Bacillus clausii in 27 adult patients with acute diarrhea, the mean ± standard deviation (SD) duration of diarrhea decreased from 34.81 ± 4.69 min at baseline to 9.26 ± 3.05 (p < 0.0001) minutes per day after 10 days
diarrhea 5007 the study concluded that Bacillus clausii can potentially be effective in alleviating the symptoms of diarrhea without causing any adverse effects [[11]].The European Society for Pediatric Gastroenterology, Hepatology,
diarrhea 5341 of Lactobacillus rhamnosus GG and Saccharomyces boulardii in the management of children with acute diarrhea as an adjunct to rehydration therapy, whereas a recommendation for Bacillus clausii is missing due to
diarrhea 5646 trials that assessed the efficacy and safety of Bacillus clausii in the treatment of acute childhood diarrhea . According to our knowledge, no systematic reviews with meta-analyses addressing the effectiveness of
diarrhea 5793 systematic reviews with meta-analyses addressing the effectiveness of Bacillus clausii in acute pediatric diarrhea have yet been published. We will focus only on studies using Bacillus clausii as a probiotic, because
diarrhea 6218 ReviewWe included randomized controlled trials conducted among children under 18 years of age with acute diarrhea (≤14 days). Patients in the experimental groups had to receive Bacillus clausii at any dose and in
diarrhea 6493 Patients in the control groups had to receive either a placebo, an appropriate standard of care for acute diarrhea in lieu of the probiotic, or no treatmentcontrol. The designations of these bacterial strains are derived
diarrhea 6832 novobiocin and rifampin, and T to tetracycline [[13]].The primary outcome measures were duration of diarrhea , stool frequency after intervention, and hospitalization duration. The secondary outcome measures were
diarrhea 7393 conducted in adult subjects or in children receiving Bacillus clausii for indications other than acute diarrhea were excluded. In vitro/vivo studies, observational studies, narrative/systematic reviews, case reports,
diarrhea 8095 October 2017. The text word terms used were: Bacillus clausii; Enterogermina; probiotic; probiotics; diarrhea ; diarrhoea; acute diarrhea; acute diarrhoea; diarrh *; children; child *; pediatric; and pediatr *.
diarrhea 8122 terms used were: Bacillus clausii; Enterogermina; probiotic; probiotics; diarrhea; diarrhoea; acute diarrhea ; acute diarrhoea; diarrh *; children; child *; pediatric; and pediatr *. In addition, we hand-searched
diarrhea 10865 study was rated « good », « fair » or «poor ».2.6. Statistical MethodsMean values and SDs of diarrhea duration, number of stools, and hospitalization duration were extracted to calculate the mean difference
diarrhea 13107 studies, two were conducted in a multicentric setting [[19],[22]]. All six studies included an outcome for diarrhea duration, four included an outcome for stool frequency [[19],[20],[22],[24]], and three included an
diarrhea 17194 ‘poor’ (high risk for bias).3.3. Primary FindingsAll six studies contained data on the duration of diarrhea . Compared to the control group (n = 441), the change in diarrhea duration in patients treated with Bacillus
diarrhea 17259 contained data on the duration of diarrhea. Compared to the control group (n = 441), the change in diarrhea duration in patients treated with Bacillus clausii (n = 457) ranged from −24.4 to +2.5 h among included
diarrhea 17437 from −24.4 to +2.5 h among included studies. In the Canani et al. (2007) trial [[19]], duration of diarrhea was expressed as median (interquartile range [IQR]) duration, whereas in three studies [[20],[21],[22]],
diarrhea 17786 Cochrane Reviewers’ Handbook 4.2.2 (2004) [[25]] and assuming normal distribution, median duration of diarrhea in the Canani et al. (2007) study [[19]] was treated as a mean value, and the width of IQR was considered
diarrhea 18068 randomized controlled trials (898 participants) showed a significant reduction in the duration of the diarrhea (mean difference = −9.12 h, 95% CI: −16.49 to −1.75) for those treated with Bacillus clausii compared
diarrhea 18280 compared to ORS with or without zinc supplementation (p = 0.015) (Figure 2). The heterogeneity test for diarrhea duration showed a substantial heterogeneity between the six studies (Cochrane’s Q test, p = 0.02,
diarrhea 18724 the first day of Bacillus clausii administration up to day 7. In the Maugo (2012) study [[20]], daily diarrhea l output was expressed as mean (SD), and it was also evaluated from day 1 of Bacillus clausii administration
diarrhea 18895 from day 1 of Bacillus clausii administration up to day 7. In the Lahiri (2008) trial [[22]], daily diarrhea l output was expressed as both mean (SD) and median (range) values, and it was evaluated from day 1 of
diarrhea 19259 and it was assessed before and after treatment with Bacillus clausii. Similarly to the duration of diarrhea , median stool frequency in the Canani et al. (2007) study [[19]] was treated as a mean value, and the
diarrhea 19562 showed that Bacillus clausii reduces the stool frequency after intervention (mean difference = −0.19 diarrhea l motions, 95% CI: −0.43 to −0.06, p = 0.14) compared with the control group which received ORS with
diarrhea 22558 publication bias was assessed by using a funnel plot depicting the mean differences in duration of diarrhea , stool frequency, and duration of hospital stay against their effect sizes as a measure of precision.
diarrhea 22737 sizes as a measure of precision. A slight asymmetry was seen in Begg’s funnel plot for duration of diarrhea , resulting in evidence of publication bias (Egger’s test, p = 0.02). In contrast, duration of hospital
diarrhea 23193 randomized controlled trials to estimate the efficacy of Bacillus clausii in the treatment of acute diarrhea in children. Results of this systematic review indicate that Bacillus clausii combined with ORS might
diarrhea 23357 that Bacillus clausii combined with ORS might significantly reduce the duration of acute childhood diarrhea and the duration of hospital stay compared to ORS alone.To our knowledge, this is the first systematic
diarrhea 23556 first systematic review focusing on randomized controlled trials of Bacillus clausii in acute childhood diarrhea . In this review, the duration of diarrhea was reduced by a mean of 9.12 h with Bacillus clausii treatment
diarrhea 23598 controlled trials of Bacillus clausii in acute childhood diarrhea. In this review, the duration of diarrhea was reduced by a mean of 9.12 h with Bacillus clausii treatment compared to controls (p = 0.015). These
diarrhea 23831 replicated in a prospective, phase II, Indian clinical study conducted among 27 adult patients with acute diarrhea treated with 2×109 CFU of Bacillus clausii twice daily for a duration of 10 days, in which mean ±
diarrhea 23955 2×109 CFU of Bacillus clausii twice daily for a duration of 10 days, in which mean ± SD duration of diarrhea decreased from 34.81 ± 4.69 min at baseline to 9.26 ± 3.05 (p < 0.0001) minutes per day after 10 days
diarrhea 24200 administration [[11]]. In contrast, in the Canani et al. (2007) trial [[19]], it was found that the duration of diarrhea in patients receiving Bacillus clausii was similar to that in the group receiving only oral rehydration,
diarrhea 25486 that in low-income countries, children under three years old experience on average three episodes of diarrhea every year [[1]]. Moreover, a 2008 study set in in Vellore, India, in 439 children under the age of
diarrhea 25660 India, in 439 children under the age of five years found that median household expenditures incurred per diarrhea l episode ranged from 2.2% to 5.8% of the household’s annual income [[26]]. Similarly, a 2013 cross-sectional
diarrhea 25882 study set in Bolivia and conducted among 1107 caregivers of pediatric patients (<5 years of age) with diarrhea found that 45% of patients’ families paid ≥1% of their annual household income for a single diarrheal
diarrhea 25987 diarrhea found that 45% of patients’ families paid ≥1% of their annual household income for a single diarrhea l episode [[27]]. Thus, diarrheal disease in children constitutes a considerable worldwide economic burden.
diarrhea 26019 patients’ families paid ≥1% of their annual household income for a single diarrheal episode [[27]]. Thus, diarrhea l disease in children constitutes a considerable worldwide economic burden. The results of this systematic
diarrhea 26241 are of particular importance, since these reductions in the length of hospital stay and duration of diarrhea that were obtained with Bacillus clausii in our analysis may offer significant social and economic benefit
diarrhea 26393 our analysis may offer significant social and economic benefit in the treatment of acute childhood diarrhea , particularly in low- and middle-income countries. In addition, in the Lahiri, Jadhav et al. (2015)
diarrhea 26751 to clarify the cost-effectiveness of Bacillus clausii preparations in treating children with acute diarrhea .The effect of Bacillus clausii on stool frequency reduction compared to ORS alone did not reach statistical
diarrhea 27322 needed to clarify the efficacy of Bacillus clausii on stool frequency reduction in acute pediatric diarrhea .Our systematic review suggested that treatment with Bacillus clausii is well tolerated, without causing
diarrhea 27596 safety results of the prospective, Phase II clinical trial conducted in 27 adult patients with acute diarrhea which found no significant change in safety parameters during treatment with Bacillus clausii [[11]].
diarrhea 28256 treatment when compared with placebo (p < 0.05) [[10]].Between-trial heterogeneity was detected for diarrhea duration and duration of hospital stay. This heterogeneity among the included studies could be partially
diarrhea 28986 group.Several mechanisms have been proposed to explain the effect of Bacillus clausii against acute childhood diarrhea . Urdaci and colleagues found Bacillus clausii to possess antimicrobial and immunomodulatory activities.
diarrhea 30854 unclear blinding, and four were unclear for or had no ITT analysis. In addition, the definition of diarrhea , the termination of diarrhea, and inclusion and exclusion criteria varied among the included studies.
diarrhea 30883 were unclear for or had no ITT analysis. In addition, the definition of diarrhea, the termination of diarrhea , and inclusion and exclusion criteria varied among the included studies. In our meta-analysis, we also
diarrhea 31033 varied among the included studies. In our meta-analysis, we also noticed publication bias detected for diarrhea duration. A key strength of the study comes from the fact that only a clearly defined probiotic micro-organism
diarrhea 31555 results indicate that Bacillus clausii might represent an effective therapeutic option in acute childhood diarrhea , with a good safety profile. One limitation of this meta-nalysis is represented by the heterogeneity
diarrhea 31935 study selection process.Figure 2Forest plot showing effect of Bacillus clausii on mean duration of diarrhea . CI, confidence interval, RE, random effects.Figure 3Forest plot showing effect of Bacillus clausii
diarrhea 32839 full strength formula of lactose or cows’ milk, depending on age, in both groups)Total duration of diarrhea , number of stools/day and their consistency, incidence and median duration of vomiting, fever (>37.5
diarrhea 33042 (>37.5 °C), number of hospital admissions, safety and tolerabilityDay 1 to day 7Median duration of diarrhea in patients receiving Bacillus clausii (118 h) similar to control group (115 h), with an estimated difference
diarrhea 33626 mg/day of zinc supplement, for 5 days vs. ORS + 20 mg/day of zinc supplement, for 5 daysDuration of diarrhea , mean number of daily stools, effect on consistency of stools, vomiting episodes per day, reported adverse
diarrhea 33897 tolerability at end of treatment periodDay 6 to day 10 (after end of study treatment)Mean (SD) duration of diarrhea lower in the experimental group (48.6 (38.2) h), vs. control group (56.1 (40) h; p = 0.13). Difference
diarrhea 34424 109 CFU of Bacillus clausii bid + ORS + zinc, for 5 days vs. ORS + zinc for 5 daysMean duration of diarrhea , mean duration of hospitalization, frequency of diarrhea, direct and indirect costsAt 6, 12, 24, 36,
diarrhea 34481 vs. ORS + zinc for 5 daysMean duration of diarrhea, mean duration of hospitalization, frequency of diarrhea , direct and indirect costsAt 6, 12, 24, 36, 48, 60, and 72 hMean duration of diarrhea 22.64 h and mean
diarrhea 34567 frequency of diarrhea, direct and indirect costsAt 6, 12, 24, 36, 48, 60, and 72 hMean duration of diarrhea 22.64 h and mean duration of hospital stay 2.78 days in the Bacillus clausii group vs. 47.05 h and 4.30
diarrhea 34735 Bacillus clausii group vs. 47.05 h and 4.30 days, respectively, in the control group (p < 0.01 for diarrhea duration). Treatment with Bacillus clausii reduced total treatment costs by 472 Indian rupees compared
diarrhea 35083 109 CFU of Bacillus clausii bid + ORS + zinc, for 5 days vs. ORS + zinc for 5 daysMean duration of diarrhea , mean stool frequency, % of children with no dehydration, % of children benefiting from breastfeedingAt
diarrhea 35249 % of children benefiting from breastfeedingAt 6, 12, 24, 36, 48, 60, and 72 hMean (SD) duration of diarrhea 22.26 h and mean stool frequency 1.15 in the Bacillus clausii group vs. 34.16 h and 1.70, respectively
diarrhea 35764 a placebo packaged in identical looking vials containing sterile water, for 5 daysMean duration of diarrhea , mean duration of hospitalization, mean reduction of the number of diarrheal episodes per dayDay 1 to
diarrhea 35840 5 daysMean duration of diarrhea, mean duration of hospitalization, mean reduction of the number of diarrhea l episodes per dayDay 1 to day 7Mean (SD) duration of diarrhea in Bacillus clausii group was shorter
diarrhea 35902 hospitalization, mean reduction of the number of diarrheal episodes per dayDay 1 to day 7Mean (SD) duration of diarrhea in Bacillus clausii group was shorter (77.59 (34.10) h) than placebo group (86.74 (40.16) h), with mean
diarrhea 36112 mean absolute difference between groups of 9.15 h (p = 0.248). Significant decrease in mean number of diarrhea l motions on day 3 (2.74 (1.81) motions in the Bacillus clausii group vs. 3.80 (2.70) motions in placebo
diarrhea 36720 per day, depending on the age of the children + ORS, for 3 days vs. ORS for 3 daysMean duration of diarrhea , mean duration of hospitalization, mean frequency of stoolsAfter day 3 of therapy, and upon dischargeMean
diarrhea 36852 hospitalization, mean frequency of stoolsAfter day 3 of therapy, and upon dischargeMean (SD) duration of diarrhea significantly shorter in the Bacillus clausii group (69.84 (16.84) h) than in control group (83.76 (22.05)
diarrhea 37024 (16.84) h) than in control group (83.76 (22.05) h) (p = 0.005), with absolute difference of duration of diarrhea between groups of 13.92 h. Mean duration of hospital stay was also shorter favoring Bacillus clausii

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