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The probiotic Bacillus clausii is an effective treatment of acute diarrhea in children

EFSM: 2022;2:220003DOI: 10.52778/efsm.22.0003Publié le: 21.01.2022
Marcos III Perez et Dorothea M. Greifenberg

A systematic review and meta-analysis confirms that the probiotic Bacillus clausii is an effective treatment for acute diarrhea in childhood. It shortens the duration of diarrhea and associated hospitalization. New studies shed light on the mechanisms underlying these beneficial effects.

Acute diarrhea in children is a global health challenge. It causes considerable suffering of affected children and their parents and is a major cause of death in developing countries. Rotavirus infection is the most frequent cause of acute diarrhea in children. In 2010, the Cochrane Collaboration reported that probiotics as a class, used alongside rehydration therapy, appear to be a safe and beneficial treatment of childhood diarrhea by shortening the duration of the condition and improving other endpoints; however, it was emphasized that more research is needed to guide the use of particular probiotic regimens [1].

B. clausii is a non-pathogenic, Gram-positive bacterium that can temporarily colonize the intestine following oral ingestion [2]. Ianiro et al. performed a systematic review and meta-analysis of randomized controlled trials testing the efficacy of B. clausii in the treatment of childhood diarrhea [3]. They identified 6 randomized controlled trials including 1298 patients and found in their meta-analysis that B. clausii reduced the duration of diarrhea by 9.12 h (95% confidence interval –16.49 to –0.15; Figure 1) and the duration of hospitalization by 0.85 days (–1.56 to –0.15). None of the 6 studies reported serious side effects. Similar findings were obtained in a more recent controlled clinical trial in 65 children [5].

Additional clinical and experimental studies support the mechanistic plausibility of the beneficial clinical effects reported in the meta-analysis. In a placebo-controlled study [5], children with rotavirus infection had lower levels of circulating IgA and increased levels of IgG and IgM compared to children without rotavirus infection. IgA levels increased after treatment and even more after addition of B. clausii, whereas IgG and IgM levels returned closer to healthy values with B. clausii. In vitro studies in Caco-2 cells, a human enterocyte cell line, found that B. clausii protected gut enterocytes against rotavirus-induced decrease in trans-epithelial resistance, apparently by up-regulating the expression of mucin 5AC and the tight junction proteins occludin and zonula occludens-1 [4]. Moreover, B. clausii inhibited reactive oxygen species production and release of the pro-inflammatory cytokines, interleukin-8 and interferon-β in rotavirus-infected cells, and down-regulated pro-inflammatory Toll-like receptor 3 pathway gene expression. Thus, B. clausii has protective effects and stimulates various non-immune mucosal barrier and innate immune system defense mechanisms.

In conclusion, B. clausii is effective and well tolerated in the treatment of childhood diarrhea, apparently by improving intestinal barrier function and innate immunity.


  1. Allen SJ, Martinez EG, et al. Probiotics for treating infectious diarrhoea. Cochrane Database of Systematic Reviews 2010;11:CD003048.
  2. Duc le H, Hong HA, et al. Characterization of Bacillus probiotics available for human use. Appl Environ Microbiol 2004;70:2161–2171.
  3. Ianiro G, Rizzatti G, et al. A Bacillus clausii for the treatment of acute diarrhea in children: a systematic review and meta-analysis of randomized controlled trials. Nutrients 2018;10:1074.
  4. Paparo L, Tripodi L, et al. Protective action of Bacillus clausii probiotic strains in an in vitro model of Rotavirus infection. Sci Rep 2020;10:12636.
  5. Smiyan OI, Smiian-Horbunova KO, et al. Optimization of the treatment of rotavirus infection in children by using bacillus clausii. Wiad Lek 2019;72:1320–1323.


Conflict of interest: M. III Perez and D. M. Greifenberg are employees of Sanofi-Aventis.

Disclosure: Medical writing and publication funded by Sanofi-Aventis Deutschland GmbH.

Affiliation/Coordonnées de l'interlocuteur: Marcos III Perez, MD, Sanofi-Aventis Deutschland GmbH, Industriepark Hoechst, 65926 Frankfurt am Main, Germany et Dorothea M. Greifenberg, PhD, Sanofi-Aventis Deutschland GmbH, Industriepark Hoechst, Frankfurt am Main, Germany
Soumis le: 25.10.2021Accepté le: 07.12.2021Publié le: 21.01.2022
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