Probiotics make up a large and growing segment of the commercial market of dietary supplements and are touted as offering a variety of human health benefits. Some of the purported positive impacts of probiotics include, but are not limited to, stabilization of the gut microbiota, prevention of gastrointestinal disorders and modulation of the host immune system. Current research suggests that the immunomodulatory effects of probiotics are strain-specific and vary in mode of action. Here, we examined the immunomodulatory properties of Bacillus subtilis strain DE111 in a healthy human population.
A clinical study evaluating the effect of DE111 on digestive health resulted in a significant influence on gut microbiota measured prior to and after capsule consumption (5 billion CFU). Fecal samples showed an increase in the levels of B. subtilis and Bifidobacterium (good bacteria) and a slight decrease in levels of E. coli (bad bacteria). DE111 was also able to maintain healthy levels of cholesterol, glucose, and triglycerides, indicating that DE111 supports the normal breakdown of complex carbohydrates, sugars, and fats.
In a pilot randomized, double-blind, placebo-controlled four-week intervention, we examined peripheral
blood mononuclear cells (PBMCs) at basal levels pre- and post-intervention, as well as in response to
stimulation with bacterial lipopolysaccharide (LPS). We observed an increase in anti-inflammatory immune
cell populations in response to ex vivo LPS stimulation of PBMCs in the DE111 intervention group. Overall perceived gastrointestinal health, microbiota, and circulating and fecal markers of inflammation (Il-6, sIgA) and gut barrier function (plasma zonulin) were largely unaffected by DE111 intervention, although the study may have been underpowered to detect these differences. These pilot data provide information and justification to conduct an appropriately powered clinical study to further examine the immunomodulatory potential of B. subtilis DE111 in human populations.
The study, “Examining the Gastrointestinal and Immunomodulatory Effects of the Novel Probiotic Bacillus
subtilis DE111'' published in the International Journal of Molecular Sciences, is an IRB-approved,
randomized, double-blind, placebo-controlled study involving 44 healthy adults (aged 20 to 62). Participants consumed either B. subtilis DE111® (1 billion CFU) or placebo daily for four weeks. The researchers examined peripheral blood mononuclear cells (PBMCs) at basal levels pre- and post-study, as well as in response to stimulation with bacterial lipopolysaccharide (LPS), which encourages neutrophils, macrophages and other innate immune cells to release pro-inflammatory cytokines. The results of the study indicated that DE111 can support a healthy immune system and a robust immune response.
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