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Bacillus Subtilis Strain De111

Q: Is DE111 safe for children?

Yes, clinical trials in preschool children have demonstrated that DE111 is safe and well-tolerated, with no reported adverse events related to its intake.

Q: Does DE111 prevent respiratory infections?

No, the pediatric clinical trial did not observe a significant reduction in the incidence of respiratory infections with DE111 supplementation.

Q: How quickly do benefits appear?

Gastrointestinal benefits, such as reduced vomiting and hard stools, were observed within 8 weeks in children. Cardiovascular improvements were noted after 4 weeks in adults.

Q: Is DE111 effective for all probiotic benefits?

Evidence supports its efficacy for gastrointestinal health in children and some cardiovascular benefits in adults. Its effects on muscle mass or other systems require further dedicated research.

Also known as: Bacillus subtilis strain DE111, DE111 probiotic strain, Bacillus subtilis DE111

Overview

Bacillus subtilis DE111 is a spore-forming probiotic bacterium naturally found in soil and fermented foods. It is utilized as a dietary supplement primarily to support gastrointestinal health and shows potential for cardiovascular benefits. Its unique ability to form spores allows it to survive the harsh acidic conditions of the stomach, ensuring viable delivery to the intestines where it can exert its beneficial effects. Research on DE111 includes randomized controlled trials (RCTs) investigating its impact on gastrointestinal function, immune modulation, and cardiovascular risk factors. While specific meta-analyses on DE111 are limited, the existing evidence, including well-designed RCTs, suggests a moderate level of support for its efficacy and safety.

Benefits

Bacillus subtilis DE111 has demonstrated several evidence-based benefits. For gastrointestinal health, a randomized, double-blind, placebo-controlled trial involving 102 preschool children (aged 2-6) showed that daily intake of 1 × 10^9 CFU of DE111 for 8 weeks significantly reduced the duration of vomiting (2 vs. 14 days), hard stools (0 vs. 15 days), and overall gastrointestinal discomfort (18 vs. 48 days) compared to placebo (p < 0.05 for all). This indicates strong evidence for its role in alleviating common GI issues in children. In terms of cardiovascular health, a 4-week RCT indicated that DE111 supplementation led to modest improvements in endothelial function (measured by reactive hyperemia index) and significant reductions in total cholesterol and non-HDL cholesterol levels, suggesting potential benefits for cardiovascular markers. While DE111 did not significantly increase salivary IgA in the pediatric study, broader probiotic research, including meta-analyses, supports the general role of probiotics in improving intestinal barrier function and reducing inflammatory markers such as CRP, TNF-α, and IL-6, providing contextual support for immune modulation.

How it works

Bacillus subtilis DE111 exerts its effects primarily through its ability to survive the harsh gastric environment as spores and then germinate in the intestine. Once active, it modulates the gut microbiota composition, potentially by competitive exclusion of pathogenic bacteria and the production of antimicrobial compounds. It also contributes to enhancing gut barrier integrity, which is crucial for preventing the translocation of harmful substances. The observed improvements in endothelial function and lipid profiles suggest systemic effects, likely mediated by complex interactions between the gut microbiota and the host, including a reduction in systemic inflammation. These mechanisms collectively contribute to its beneficial effects on gastrointestinal and cardiovascular health.

Side effects

Bacillus subtilis DE111 has shown a favorable safety profile in clinical trials. The pediatric randomized controlled trial reported no adverse events directly related to DE111 supplementation, indicating its safety and tolerability in children. Similarly, no significant side effects or contraindications have been documented in other available clinical trials. As a spore-forming probiotic, DE111 is generally considered safe for healthy individuals. However, as with all probiotics, caution is advised for immunocompromised individuals due to a theoretical, albeit low, risk of infection. There are no known significant drug interactions reported for DE111, but individuals on immunosuppressants or with severe underlying health conditions should consult a healthcare professional before use.

Dosage

The effective dosage of Bacillus subtilis DE111, as established in clinical studies, is 1 × 10^9 CFU (colony-forming units) daily. This dose was used in an 8-week study for children addressing gastrointestinal health and in a 4-week study for adults investigating cardiovascular benefits. There is currently no established maximum safe dose, as the doses used in trials are considered well within safe limits. Daily oral administration is the standard method of intake. While specific timing (e.g., with or without food) and formulation details are not extensively studied, consistency in daily intake is generally recommended to maintain its beneficial effects. Always adhere to the dosage instructions provided by the supplement manufacturer or a healthcare professional.

FAQs

Is DE111 safe for children?

Yes, clinical trials in preschool children have demonstrated that DE111 is safe and well-tolerated, with no reported adverse events related to its intake.

Does DE111 prevent respiratory infections?

No, the pediatric clinical trial did not observe a significant reduction in the incidence of respiratory infections with DE111 supplementation.

How quickly do benefits appear?

Gastrointestinal benefits, such as reduced vomiting and hard stools, were observed within 8 weeks in children. Cardiovascular improvements were noted after 4 weeks in adults.

Is DE111 effective for all probiotic benefits?

Evidence supports its efficacy for gastrointestinal health in children and some cardiovascular benefits in adults. Its effects on muscle mass or other systems require further dedicated research.

Research Sources

https://www.longdom.org/open-access/effect-of-daily-bacillus-subtilis-de111-intake-on-gastrointestinalhealth-and-respiratory-infections-in-children-attending-daycare--59503.html – This randomized, double-blind, placebo-controlled trial investigated the effect of daily DE111 intake (1 × 10^9 CFU) in 102 preschool children over 8 weeks. It found that DE111 significantly reduced the duration of vomiting, hard stools, and overall gastrointestinal discomfort, demonstrating its safety and efficacy for pediatric GI health. No significant effect on respiratory infection incidence was observed.
https://pmc.ncbi.nlm.nih.gov/articles/PMC8773468/ – This randomized controlled trial explored the impact of DE111 supplementation on cardiovascular markers in adults over 4 weeks. The study reported modest improvements in endothelial function and significant reductions in total cholesterol and non-HDL cholesterol levels, suggesting potential benefits for cardiovascular health. The findings indicate DE111's role in modulating lipid profiles and vascular health.
https://www.frontiersin.org/journals/immunology/articles/10.3389/fimmu.2023.1143548/full – This systematic review and meta-analysis, encompassing 26 RCTs with 1891 participants, examined the broader effects of probiotics on gut barrier function and inflammation. While not specific to DE111, it provides strong contextual evidence that probiotics generally improve gut barrier integrity and reduce inflammatory markers like CRP, TNF-α, and IL-6, supporting the general mechanisms of probiotic action relevant to DE111.