Benefits
Bowel regularity and stool consistency
In a 90-day trial in 50 adults with occasional constipation or diarrhea, 1 billion CFU of DE111 a day improved a bowel transit score within the group, and by the end a larger share of stools were normal than in the placebo group. That comparison counted individual stools rather than people, and the trial was funded and run by the maker.
Inflammation marker and body fat in college athletes
In 25 male baseball players, 12 weeks of DE111 left TNF-alpha, an inflammation marker, lower than placebo, but body composition, performance, hormones and gut permeability did not differ. In 23 female athletes, 5 billion CFU a day for 10 weeks gave a larger drop in body fat than placebo, with no difference in strength or performance.
Spores reach and germinate in the small intestine
In 11 people with an ileostomy, DE111 spores and active cells both appeared in fluid from the small intestine about 3 hours after a capsule was swallowed, and their numbers rose over the next few hours. The study was small and run by the maker, but it shows the spores survived the stomach in people.
Immune cell responses in healthy adults
In a 4-week placebo-controlled pilot in healthy adults funded by the maker, immune cells taken from the DE111 group showed a rise in anti-inflammatory cell types when stimulated in the lab. Gut symptoms, gut bacteria, IL-6, secretory IgA and zonulin were largely unchanged. In baseball players, salivary IgA rose over training in both groups.
Mechanism of action
Spore survival and germination
B. subtilis forms dormant spores that can wait out harsh conditions. In people, swallowed DE111 spores reached the small intestine and began germinating within about 3 hours. Lab and genome work on DE111 found genes linked to acid and stress tolerance.
Antimicrobial compounds in laboratory tests
Genome and laboratory analysis of DE111 found genes for bacteriocins, which are antimicrobial proteins, and activity against a range of bacteria in culture. Whether this matters in the human gut has not been tested.
Digestive enzyme production
In the laboratory, DE111 showed protease, peptidase, esterase and carbohydrate-digesting activity, and it released amino acids and short-chain fatty acids when grown in milk. Whether it adds meaningfully to human digestion has not been measured.
Clinical trials
Randomized, double-blind, placebo-controlled trial; 1 billion CFU DE111 or placebo daily for 90 days, with a 105-day total follow-up. Funded by Deerland, and all authors work there. Not PubMed-indexed. (Cuentas et al. 2017, J Probiotics Health)
50 adults aged 18 to 65 with occasional constipation and/or diarrhea (65 enrolled, 15 excluded or withdrawn).
Within the DE111 group, bowel transit scores improved from the first 2 weeks to the last 2 weeks (p = 0.0369), while the placebo group did not change significantly. In the last 2 weeks the share of normal stools was higher with DE111 than with placebo, in a test that counted individual stools rather than people. No adverse effects were reported.
Randomized, placebo-controlled trial during a 10-week offseason resistance training program; 5 billion CFU DE111 or placebo daily. (Toohey et al. 2020, J Strength Cond Res)
23 Division I female soccer and volleyball players during the offseason.
Body fat fell more with DE111 (about 2.05 percentage points) than with placebo (about 0.2 points; group by time p = 0.015). Strength, jump, agility and muscle thickness improved over time in both groups with no difference between them.
Double-blind, placebo-controlled, randomized trial; 1 billion CFU DE111 or placebo daily over 12 weeks of offseason training. (Townsend et al. 2018, Sports (Basel))
25 Division I male baseball players.
TNF-alpha, an inflammation marker, was lower with DE111 than placebo (p = 0.024). There were no group differences in body composition, performance, testosterone, cortisol, IL-10, zonulin or salivary antibodies.
Pilot randomized, double-blind, placebo-controlled trial; 1 billion CFU DE111 or maltodextrin placebo daily for 4 weeks. Funded by Deerland, which supplied the capsules. (Freedman et al. 2021, Int J Mol Sci)
46 healthy adults aged 20 to 62 (44 completed).
Blood immune cells from the DE111 group showed more anti-inflammatory cell types after lab stimulation. Perceived gut health, gut bacteria, inflammation markers (IL-6, secretory IgA) and zonulin were largely unaffected; the authors say the study may have been too small to detect differences.