Examining the Gastrointestinal and Immunomodulatory Effects of the Novel Probiotic Bacillus subtilis DE111

Abstract

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. 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.

Preclinical Safety Assessment of Bacillus subtilis BS50 for Probiotic and Food Applications

“…For example, the B. subtilis strain MB40 has been shown to be safe and support GI health in a randomized, double-blind, placebo-controlled trial of 100 healthy adults [ 17 , 35 ]. Additionally, B. inaquosorum DE111 supplementation has been shown to be safe in both adult and pediatric human subjects [ 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 ]. Altogether, these studies provide a large body of clinical evidence that Bacillaceae spp., including B. subtilis , are safe for human consumption.…”

Probiotic Bacillus subtilis LF11 Protects Intestinal Epithelium Against Salmonella Infection

“…Recently, several clinical and animal trials have demonstrated the protection of B. subtilis against Salmonella and other enteropathogenic bacteria in broilers through the load reduction in intestinal tracts, improvement of the growth performance, and immune responses ( Wu et al., 2018 ; Sokale et al., 2019 ; Abudabos et al., 2020 ). Nevertheless, the action modes of probiotic B. subtilis are in a strain-specific manner ( Freedman et al., 2021 ), which makes it necessary to investigate the potential protection against Salmonella infection in poultry farming.…”

The probiotic Bacillus subtilis BS50 decreases gastrointestinal symptoms in healthy adults: a randomized, double-blind, placebo-controlled trial

“…inaquosorum DE111; 2.5 × 10 9 CFU/day) for 4 weeks showed no difference in participant self-reported GI symptoms compared to placebo groups. 50 , 51 It is noteworthy that the aforementioned studies and ours were dissimilar on several aspects that may contribute to the contrast in results. These include differences in supplementation length (4 weeks vs. 6 weeks), questionnaires used, as well as definition and analysis of efficacy outcomes (odds ratio vs. mean scores).…”