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Randomised controlled clinical trial of Lactobacillus sporogenes (Bacillus coagulans), used as probiotic in clinical practice, on acute watery diarrhoea in children.

  • 2011-02-20
  • Tropical medicine & international health : TM & IH 16(5)
    • Phalguni Dutta
    • Utpala Mitra
    • Shanta Dutta
    • Krishnan Rajendran
    • Tushar Kanti Saha
    • Mrinal Kanti Chatterjee

Study Design

Type
Randomized Controlled Trial (RCT)
Population
children aged 6-24 months who had diarrhoea with some dehydration
Methods
Double-blind, randomised, placebo-controlled, hospital-based clinical trial; children received tablets of L. sporogenes (B. coagulans) or placebo and oral rehydration salt solution
Blinding
Double-blind

Objective

To assess the clinical efficacy of Lactobacillus sporogenes (Bacillus coagulans), as probiotic preparation, against dehydrating diarrhoea in children.

Methods

Double-blind, randomised, placebo-controlled, hospital-based clinical trial with children aged 6-24 months who had diarrhoea with some dehydration. Children received tablets of L. sporogenes (B. coagulans) or placebo (control group) and oral rehydration salt solution for correction of initial dehydration as well as maintenance therapy. Duration, frequency, volume of diarrhoea and intake of ORS of two groups were compared as outcome variables.

Results

One hundred and forty-eight children participated, of whom 78 (Study group) received L. sporogenes (B. coagulans) and 70 received placebo (Control group). Differences in recovery rate (P=0.2), duration (P=0.5), frequency (P=0.05), volume (P=0.1) of diarrhoea, intake of ORS (P=0.2) and other fluids (P=0.1) were not significant between both groups. Neither did a subgroup analysis of children who had rotavirus as sole enteropathogens show any significant differences in duration (P=0.5), frequency (P=0.6), volume (P=0.8) of diarrhoea, intake of ORS (P=0.8) and other fluids (P=0.8) among both groups.

Conclusion

L. sporogenes (B. coagulans), as an adjunct to ORS, had no therapeutic impact on management of acute dehydrating diarrhoea of diverse etiology including rotavirus associated diarrhoea in children.

Research Insights

  • Bacillus coagulans→Improved Recovery Rate

    Differences in recovery rate (P=0.2), duration (P=0.5), frequency (P=0.05), volume (P=0.1) of diarrhoea, intake of ORS (P=0.2) and other fluids (P=0.1) were not significant between both groups.

    Effect
    Neutral
    Effect size
    Small
    Dose
    not stated
  • Bacillus coagulans→Reduced Diarrhea Frequency

    Differences in recovery rate (P=0.2), duration (P=0.5), frequency (P=0.05), volume (P=0.1) of diarrhoea, intake of ORS (P=0.2) and other fluids (P=0.1) were not significant between both groups.

    Effect
    Neutral
    Effect size
    Small
    Dose
    not stated
  • Bacillus coagulans→Reduced Diarrhea Rate

    Subgroup analysis ... no significant differences in ... intake of ORS (P=0.8) and other fluids (P=0.8) among both groups.

    Effect
    Neutral
    Effect size
    Small
    Dose
    tablets (dose not specified in abstract)
  • Bacillus coagulans→Reduced Diarrhea Volume

    Subgroup analysis ... no significant differences in ... volume (P=0.8) of diarrhoea ... among both groups.

    Effect
    Neutral
    Effect size
    Small
    Dose
    tablets (dose not specified in abstract)
  • Bacillus coagulans→Reduced Duration of Diarrhea

    Differences in recovery rate (P=0.2), duration (P=0.5), frequency (P=0.05), volume (P=0.1) of diarrhoea, intake of ORS (P=0.2) and other fluids (P=0.1) were not significant between both groups.

    Effect
    Neutral
    Effect size
    Small
    Dose
    not stated
  • Bacillus coagulans→Reduced Oral Rehydration Solution Intake

    Differences in recovery rate (P=0.2), duration (P=0.5), frequency (P=0.05), volume (P=0.1) of diarrhoea, intake of ORS (P=0.2) and other fluids (P=0.1) were not significant between both groups.

    Effect
    Neutral
    Effect size
    Small
    Dose
    not stated
  • Bacillus coagulans→Reduced Other Fluid Intake

    Subgroup analysis ... no significant differences in ... intake of ORS (P=0.8) and other fluids (P=0.8) among both groups.

    Effect
    Neutral
    Effect size
    Small
    Dose
    tablets (dose not specified in abstract)
  • Bacillus coagulans→Reduced Recovery Rate

    Differences in recovery rate (P=0.2) ... were not significant between both groups.

    Effect
    Neutral
    Effect size
    Small
    Dose
    tablets (dose not specified in abstract)
  • Bacillus coagulans→Reduced Stool Volume

    Differences in ... volume (P=0.1) of diarrhoea ... were not significant between both groups.

    Effect
    Neutral
    Effect size
    Small
    Dose
    tablets (dose not specified in abstract)

Adverse Events Reported

  • Bacillus coagulans→Overall tolerability

    Differences in recovery rate (P=0.2), duration (P=0.5), frequency (P=0.05), volume (P=0.1) of diarrhoea, intake of ORS (P=0.2) and other fluids (P=0.1) were not significant between both groups.

    Finding
    No significant difference
    Significant
    No
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