Comparative study of Bacillus clausii and multistrain probiotics in the management of acute diarrhoea in children

Abstract

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.

Immunomodulatory and Antioxidant Properties of a Novel Potential Probiotic Bacillus clausii CSI08

“…Similarly, B clausii ( A. clausii 088AE) showed their efficacy for managing diarrhea caused by broad-spectrum antibiotics in both children and adults [ 27 ]. Treatment with probiotic strains of B. clausii were also effective in reducing main clinical symptoms of acute diarrhea, including rotavirus-associated diarrhea in children [ 28 , 29 , 30 , 31 ]. In a recently published prospective study, B. clausii (O/C, N/R, SIN and T) was beneficial for managing symptoms of IBS in children [ 31 ].…”

Bacillus clausii for Gastrointestinal Disorders: A Narrative Literature Review

“…In a prospective, single-blind, randomized controlled trial, Hamid et al [ 72 ] randomized 300 infants and children (aged 6 months to 6 years) with acute watery diarrhea to standard of care treatment alone or in combination with B. clausii (O/C, N/R, SIN and T; 2 × 10 9 CFU) b.i.d. for 5 days or a multi-strain probiotic once a day for 5 days ( n = 100 per group).…”

“…The clinical studies we identified in this narrative literature review of B. clausii probiotics and GI health largely support the beneficial effects of B. clausii for managing a variety of GI disorders and their symptoms. From preliminary observations of early clinical studies to recent and robustly designed clinical trials, randomized placebo-controlled trials and meta-analyses and pooled analyses, the evidence indicates that B. clausii is effective for treating and/or preventing antibiotic-associated diarrhea in adults and children [ 63 – 68 ] and acute diarrhea in adults [ 81 – 83 ], with most, but not all [ 70 , 73 ], studies supporting the effectiveness of B. clausii in acute childhood diarrhea [ 69 , 71 , 72 , 74 – 80 ]. Evidence from these studies and clinical use over many decades indicates that B. clausii is safe and well tolerated in adults and children [ 29 ].…”

“…Evidence from two randomized controlled trials in acute childhood diarrhea indicates a significantly lower frequency of diarrhea after B. clausii treatment (O/C, N/R, SIN and T or UBBC07) versus standard of care [ 72 , 74 ], although no significant changes in daily stool output were observed in another trial (O/C, N/R, SIN and T) [ 73 ]. Moreover, two separate systematic review and meta-analyses of randomized controlled trials demonstrated significantly lower duration of acute diarrhea in children treated with B. clausii (O/C, N/R, SIN and T) compared with control [ 77 , 78 ].…”

Efficacy and Safety of the Adjuvant Use of Probiotic Bacillus clausii Strains in Pediatric Irritable Bowel Syndrome: A Randomized, Double-Blind, Placebo-Controlled Study

“…B. clausii has demonstrated beneficial effects in adults, such as in ameliorating bacterial overgrowth [ 12 ], acute diarrhea [ 13 , 14 ], diarrhea associated with Clostridium difficile [ 15 ], and as an adjuvant in treating Helicobacter pylori [ 16 , 17 ]. Importantly, benefits of B. clausii have also been demonstrated in children, such as in antibiotic-associated diarrhea [ 18 , 19 ], diarrhea [ 13 , 14 , 20 – 25 ], and rotavirus-associated diarrhea [ 26 , 27 ].…”