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Background: Diarrhoea is the second most common cause of under-five mortality especially in developing world. Many studies have been conducted so far using different probiotic strains with variable outcome. So, the aim of the present study was to compare the clinical efficacy of Bacillus clausii and multi strain probiotic formulation as adjunct treatment of acute diarrhoea.Methods: This prospective single blind randomized controlled clinical trial included 300 infants and children between 6 months to 6 years of age admitted in a tertiary care hospital Sylhet, Bangladesh with acute watery diarrhoea having varied dehydration status ranging from no to severe dehydration excluding shocked state. Cases were randomly assigned to three groups which were group I (n=100) comprised of children who were treated with standard treatment (according to WHO guideline) only as control group, group II (n=100) who received standard treatment plus Bacillus clausii and group III (n=100) who received standard treatment plus multi strain probiotic formulation (Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium breve, Bifidobacterium infantis, Streptococcus thermophilus). Primary outcome variables were duration, frequency of diarrhoea and consistency of stool. Secondary outcome variable was duration of hospital stay.Results: Mean duration of diarrhoea was significantly shorter (p=0.001) in group III (2.62 days) compared to group I (3.26 days) and group II (3.22 days). Frequency of diarrhoea was significantly lower on day 3 of probiotic administration in group III (p <0.05) and on day 5 of treatment in group II (p <0.05). Stool consistency significantly improved on day 3 in group III (p <0.05) while it was on day 4 in group II. The duration of diarrhoea, hospital stay, stool consistency and frequency of stool on day 3 were not statistically significant (p >0.05) in group II in comparison to group I and group III.Conclusions: Multistrain probiotic formulation is effective in reducing the duration, frequency of diarrhoea and duration of hospital stay.
RESUMEN
INTRODUCTION: Antibiotic-associated diarrhea (AAD) is an important side effect of this specific class of drugs. The objective of this study was to investigate the effect of the use of probiotics in the treatment of AAD. METHODS: A group of hospitalized patients, who contracted diarrhea during or after 7 days of suspension of antimicrobial medication, was blindly randomized to receive a standardized diet associated with the use of the probiotics (Lactobacillus casei and Bifidobacterium breve) or its corresponding placebo, three times a day. RESULTS: Seventy patients were studied. For the experimental (n=35) and control (n=35) groups, respectively, the average time of treatment was 5.06±2.18 and 5.49±3.17 days (p=0.95), and the average duration of diarrhea, among those who were healed, was 4.87±2.13 and 4.52±2.55 days (p=0.36). Four (11.4 percent) patients who received probiotics and ten (28.6 percent) who received the placebo were not cured (p=0.13), and relapse rates were similar between both groups. Seven patients from each group, in addition to diarrhea, presented cases of bloating and/or abdominal cramps and/or vomiting (p=1.00). CONCLUSIONS: In this light, it is concluded that L. casei associated with B. breve, in the administered dosage and frequency, has no effect on the antibiotic-associated diarrhea. Similar studies need to be conducted with higher doses of these or other probiotics.
INTRODUÇÃO: A diarréia associada ao uso de antimicrobiano (DAA) é um importante efeito colateral dessa classe de fármacos. O objetivo do presente trabalho é investigar o efeito do uso de probióticos no tratamento da DAA. MÉTODOS: Pacientes hospitalizados em um hospital universitário com diarréia, que se desenvolveu durante o uso ou até sete dias após a suspensão de antimicrobianos, foram randomizados, de forma cega, para receberem dieta padronizada associada, três vezes ao dia, ao uso de probiótico (Lactobacillus casei e Bifidobacterium breve) ou placebo. RESULTADOS: Foram estudados um total de setenta pacientes. Para o grupo experimento (n=35) e controle (n=35), respectivamente, o tempo médio de tratamento foi de 5,06 ± 2,18 e 5,49 ± 3,17dias (p=0,95) e o tempo médio de duração da diarréia, entre aqueles que se curaram, foi de 4,87 ± 2,13 e 4,52 ± 2,55 dias (p=0,36). Quatro (11,4 por cento) pacientes que receberam probióticos e dez (28,6 por cento) que receberam placebo não foram curados (p=0,13) e a frequência de recidiva foi similar entre os grupos. Sete pacientes de cada grupo, além da diarréia, apresentaram distensão e/ou cólica abdominal e/ou vômito (p=1,00). CONCLUSÕES: L. casei associado a B. breve, na dosagem e frequência administradas, não demonstraram qualquer efeito no tratamento da diarréia associada a antimicrobiano. Estudos similares merecem ser realizados com doses maiores destes ou de outros probióticos.