Benefits
Gut bacteria balance in preschool children
In a randomized placebo-controlled study of healthy children aged 2 to 6 in day care, 8 weeks of DE111 did not change overall gut microbiome balance between groups, but bacterial diversity rose from baseline and several bacterial groups shifted. The authors described the changes as subtle. A Deerland employee was an author.
Survival through digestion to the small intestine
In 11 adults with an ileostomy, DE111 spores appeared in the fluid leaving the small intestine within 3 hours of a dose, and active, germinated cells were plentiful by 7 hours. This shows the strain survives the stomach and becomes active in the small intestine. The study was run by Deerland staff and did not measure health outcomes.
Digestive comfort in healthy adults
In a 4-week randomized placebo-controlled trial in healthy adults funded by Deerland, perceived gastrointestinal health, gut bacteria, and markers of gut barrier function and inflammation were largely unchanged by DE111. The authors noted the study may have been too small to detect differences.
Immune cell markers
In the same 4-week trial, blood immune cells from the DE111 group formed more anti-inflammatory cell types when challenged with a bacterial toxin in the lab, while IL-6 and IgA were unchanged. In 25 college baseball players, 12 weeks of 1 billion CFU a day lowered blood TNF-alpha versus placebo, with no change in other markers. No trial measured infections.
Mechanism of action
Spore survival and germination
As a spore, DE111 can pass through stomach acid and bile. In people with an ileostomy, swallowed spores reached the end of the small intestine within 3 hours and germinated into active cells there.
Activity in the small intestine after a dose
In ileostomy samples collected after a dose, DE111 was linked to higher levels of some plant polyphenols and of proteins involved in immune cell recruitment, antimicrobial defense and the intestinal lining. Apart from its own presence, it had little detectable effect on the bacteria in the samples.
Clinical trials
Pilot randomized double-blind placebo-controlled trial of DE111 for 4 weeks, funded by Deerland, which also supplied and blinded the capsules. (Freedman et al. 2021, Int J Mol Sci)
Healthy adults; the number enrolled is not given in the abstract.
Blood immune cells from the DE111 group produced more anti-inflammatory cell populations when stimulated with bacterial toxin in the lab. Perceived gastrointestinal health, gut bacteria, IL-6, fecal IgA and the gut barrier marker zonulin were largely unaffected. The authors said the study may have been underpowered.
Randomized crossover double-blind placebo-controlled study sampling ileostomy fluid for 8 hours after a dose. Run by Deerland employees with hospital and public research partners. (Colom et al. 2021, Front Microbiol)
11 adults with an ileostomy.
Spores and active cells of B. subtilis appeared in ileal fluid 3 hours after ingestion; spore levels rose by 6 hours and active cells were plentiful by 7 hours, showing the strain survives the stomach and germinates in the small intestine.
Randomized double-blind placebo-controlled study analyzing ileostomy samples for metabolites, proteins and bacteria after DE111. Run mainly by Deerland employees. (Colom et al. 2023, Benef Microbes)
Adults with an ileostomy; the number is not given in the abstract.
DE111 increased some polyphenols and other metabolites and raised proteins involved in immune cell recruitment, antimicrobial defense and the intestinal brush border. It had limited effect on the gut bacteria apart from its own increased presence. Health outcomes were not measured.
Randomized placebo-controlled trial of DE111 once daily for 8 weeks. One author is a Deerland employee. (Paytuví-Gallart et al. 2020, Benef Microbes)
Healthy children aged 2 to 6 attending day care; the number is not given in the abstract.
Overall microbiome balance did not change between groups or over time. Within the DE111 group, bacterial diversity rose and the Firmicutes to Bacteroidetes ratio fell, with shifts in several bacterial groups. The authors called the changes subtle.
Randomized double-blind placebo-controlled trial of 1 billion CFU DE111 daily during 12 weeks of offseason training. (Townsend et al. 2018, Sports (Basel))
25 Division I male baseball players (13 on DE111, 12 on placebo).
Blood TNF-alpha was lower with DE111 than placebo. There were no group differences in body composition, performance, testosterone, cortisol, IL-10, zonulin or salivary antibodies.