Bacillus subtilis
Spore Strain · HU58 / DE111
Evidence grade 2 of 5, Thin. Read how the Atlas grades evidence.
4 human trials, about 40 studies, ~1,500 participants. The written rationale for this grade is still being prepared.
- FDA
- GRAS
- WADA
- Not prohibited
Reference only. Not medical advice.
What can go wrong
In healthy people B. subtilis is generally well tolerated, with no serious adverse effects reported up to roughly 10 billion CFU/day in the trials to date. The meaningful caution is for people who are immunocompromised: a documented case report (Oggioni et al., J Clin Microbiol 1998) described recurrent B. subtilis septicemia in a 73-year-old with chronic lymphocytic leukemia after a commercial spore preparation, and later reviews echo that severely immunocompromised patients face rare but real Bacillus bloodstream-infection risk from live-organism products. Because these strains are naturally antibiotic-resistant and produce antimicrobial compounds, the theoretical diversity-disruption question raised for spore probiotics applies here too, and long-term human data are limited. Anyone who is immunocompromised, seriously ill, pregnant, or considering it for a child should consult a qualified healthcare provider before use rather than self-prescribing.
Bacillus subtilis is a spore-forming bacterium found in soil and, as the variety B. subtilis natto, in the traditional Japanese fermented soybean food natto. Because it forms heat- and acid-resistant spores, it survives stomach transit and germinates in the small intestine, which makes it shelf-stable and a common ingredient in spore-based supplements under strain names such as DE111 and HU58. It is one of the most-studied bacteria in biology and a workhorse of industrial fermentation. Human evidence for supplement benefit is early: small, mostly industry-funded trials of DE111 report signals in immune-cell activity and shorter duration of some digestive symptoms, while overall microbiome composition, respiratory infection, and most inflammation markers were unchanged. Its long food-safety record in natto is well established; proven clinical benefit as a capsule is not yet.
A soil and natto bacterium that makes its own antibiotics to crowd out pathogens.
What people take it for
These are the reasons people give for taking it. They are not effects it has been shown to have.
What people get wrong
Often saidMaking natural antibiotics means it sterilizes your gut
ActuallyThe dozens of antimicrobial compounds B. subtilis can produce (surfactin, subtilin, iturin, fengycin and others) are targeted competitive-exclusion agents against rival microbes, not broad sterilants; in the DE111 pediatric trial alpha diversity actually rose. That said, the same competitive mechanism is exactly why long-term effects on beneficial diversity still warrant measurement. (Frontiers in Microbiology 2019 review; Beneficial Microbes DE111 pediatric trial)
Often saidIt is a proven immune and digestive remedy
ActuallyHuman supplement trials are small and mostly industry-funded. DE111 showed a regulatory T-cell signal after LPS stimulation and shorter duration of some GI symptoms, but no change in overall microbiome equilibrium, respiratory-infection rate, or most inflammation markers, and the lead authors called their own results preliminary and underpowered. (Freedman et al., Int J Mol Sci 2021)
Often saidBecause natto is a rich vitamin K2 source, B. subtilis supplements deliver that benefit too
ActuallyThe MK-7 (vitamin K2) content is a property of the natto fermentation of soybeans, not something a spore capsule automatically supplies; MK-7 supplements are made by fermenting substrate, not by taking a probiotic. (Nutrition/ScienceDirect MK-7 literature)
Often saidIt is a native gut resident that colonizes you
ActuallyB. subtilis is chiefly a soil and food organism; ingested spores germinate transiently in the small intestine (within about 3 hours in the ileostomy study) and are largely cleared, rather than establishing permanent residence. (Colom et al., 2021 germination study)
Who profits, and who pushes back
Maurizio Oggioni and colleagues
They documented recurrent septicemia in an immunocompromised patient traced to probiotic strains of Bacillus subtilis, concluding that live-organism products carry real risk for severely immunocompromised people and should be used cautiously in that group.
Microbiome-diversity researchers
A bacterium that produces antibiotics to outcompete others is effective against pathogens but raises legitimate questions about its effect on beneficial gut diversity that short, sponsor-funded trials have not yet answered.
Independent evidence reviewers
The human trials are small and funded by the ingredient manufacturer, and they are null on overall microbiome composition and respiratory infection, so the honest label is 'preliminary,' the word the study authors themselves used.
Spore-probiotic brands
Sells this. Has a commercial interest in a product sold as this compound, as of July 2026.
Feature B. subtilis (often HU58) for immune claims; commercial interest.
Natto and fermented-food advocates
Point to B. subtilis natto as a traditional dietary source.
Where the research comes from
| Place | Share of published research |
|---|---|
| USA | 36% |
| Europe | 30% |
| Asia | 20% |
| Other | 14% |
Research published from: Global.
How we got here
Bacillus subtilis reached people first as food, not as a supplement. Its variety B. subtilis natto ferments the Japanese dish natto, whose lineage traces through Chinese fermented soybeans (douchi) and is bound up with early Japanese practice: the name natto is associated with the Heian period and the dish with legends around Minamoto no Yoshiie's northeastern campaigns of 1086 to 1088, traditionally made by wrapping boiled soybeans in rice straw carrying wild Bacillus. Natto is among the richest known food sources of vitamin K2 (menaquinone-7), synthesized by the bacterium during fermentation. Western science arrived later: Ehrenberg described Vibrio subtilis in 1835, and Ferdinand Cohn renamed and placed it in the genus Bacillus in 1872. In the twentieth century it became a model organism for genetics and sporulation, with its genome sequenced in 1997. Specific spore strains such as DE111 and HU58 were selected for supplement use only in the 2010s.
- 8th-11th c.Fermented-soybean tradition develops in Japan from Chinese douchi; the name natto emerges
- 1086-1088Legend ties natto's discovery to Minamoto no Yoshiie's northeastern campaign (straw-wrapped soybeans)
- 1835Ehrenberg describes the organism as Vibrio subtilis
- 1872Ferdinand Cohn renames it Bacillus subtilis and establishes the genus
- 1912-1926Taisho-era researchers develop a straw-free B. subtilis natto starter, enabling commercial natto
- 1997B. subtilis genome fully sequenced; it becomes a leading bacterial model organism
- 2019FDA files DE111 GRAS notice (GRN 831) without questions
- 2021Small Deerland-funded DE111 human RCTs (adults and children) and the ileostomy germination study are published
At a glance
- Type
- Spore-forming Bacillus
- Found in
- Soil, natto
- Trait
- Produces natural antibiotics
- Strains
- HU58, DE111
What this entry does not yet cover
What follows is unfinished work on our side, not a finding about Bacillus subtilis. A short entry is not a safe entry.
- Cost and market. We have not documented what it sells for or who sells it.
- Supply chain. We have not mapped where it is made.
- Who uses it. We have not documented the user groups.
- What could change. No forward-looking summary yet.
- How it compares. We have not set it against the alternatives.
- Children and teenagers. We have not checked what is known about younger people.
Sources
DE111 4-week adult RCT: regulatory T-cell signal after LPS, no change in GI symptoms/microbiota/most markers; authors call it preliminary and underpowered; Deerland-funded
Freedman et al., International Journal of Molecular Sciences (via PMC)
DE111 spores germinate in the human small intestine within ~3 hours; n=11 ileostomy crossover; Deerland/Enterprise Ireland funded
Colom et al., Presence and Germination of DE111 in the Human Small Intestinal Tract (via PMC)
DE111 daycare pediatric RCT: shorter duration of some GI symptoms, no reduction in respiratory infection, Deerland-sponsored
Effect of Daily B. subtilis DE111 Intake in Children Attending Day-care (Longdom)
DE111 pediatric trial: increased alpha diversity, no change in overall microbiome equilibrium; industry-sponsored
NutraIngredients report on Beneficial Microbes DE111 preschool-children study
Recurrent B. subtilis septicemia in an immunocompromised (CLL) patient after a commercial spore probiotic (Enterogermina)
Natto history, Chinese douchi lineage, straw fermentation, B. subtilis var. natto, Taisho-era starter, MK-7 origin
Ehrenberg 1835 Vibrio subtilis; Cohn 1872 renaming and genus; 1997 genome; model-organism status
Bacillus subtilis, a Swiss Army Knife in Science and Biotechnology (PMC review)
B. subtilis group produces more than two dozen structurally distinct antimicrobial compounds (surfactin, subtilin, iturin, fengycin, etc.)
DE111 GRAS status via GRAS Notice GRN 831 for use as a probiotic in food
EFSA QPS status for B. subtilis contingent on strain identity, non-toxigenicity, and absence of acquired antimicrobial resistance
Preclinical Safety Assessment of B. subtilis BS50 (PMC), summarizing EFSA QPS criteria
Natto as among the richest dietary MK-7 sources; habitual intake associated with higher serum MK-7 in Japanese populations