Dataset Information

Presence and Germination of the Probiotic Bacillus subtilis DE111^® in the Human Small Intestinal Tract: A Randomized, Crossover, Double-Blind, and Placebo-Controlled Study.

ABSTRACT: Spore-based probiotics offer important advantages over other probiotics as they can survive the harsh gastric conditions of the stomach and bile salts in the small intestine, ultimately germinating in the digestive tract. A novel clinical trial in 11 ileostomy participants was conducted to directly investigate the presence and germination of the probiotic strain Bacillus subtilis DE111^® in the small intestine. Three hours following ingestion of DE111^®, B. subtilis spores (6.4 × 10⁴ ± 1.3 × 10⁵ CFU/g effluent dry weight) and vegetative cells (4.7 × 10⁴ ± 1.1 × 10⁵ CFU/g effluent dry weight) began to appear in the ileum effluent. Six hours after ingestion, spore concentration increased to 9.7 × 10⁷ ± 8.1 × 10⁷ CFU/g and remained constant to the final time point of 8 h. Vegetative cells reached a concentration of 7.3 × 10⁷ ± 1.4 × 10⁸ CFU/g at 7 h following ingestion. These results reveal orally ingested B. subtilis DE111^® spores are able to remain viable during transit through the stomach and germinate in the small intestine of humans within 3 h of ingestion.

SUBMITTER: Colom J

PROVIDER: S-EPMC8366289 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

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Presence and Germination of the Probiotic Bacillus subtilis DE111® in the Human Small Intestinal Tract: A Randomized, Crossover, Double-Blind, and Placebo-Controlled Study.

Colom Joan J Freitas Daniela D Simon Annie A Brodkorb Andre A Buckley Martin M Deaton John J Winger Alison M AM

Frontiers in microbiology 20210802

Spore-based probiotics offer important advantages over other probiotics as they can survive the harsh gastric conditions of the stomach and bile salts in the small intestine, ultimately germinating in the digestive tract. A novel clinical trial in 11 ileostomy participants was conducted to directly investigate the presence and germination of the probiotic strain Bacillus subtilis DE111® in the small intestine. Three hours following ingestion of DE111®, B. subtilis ...[more]

PMID: 34408741

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Project description:Bacillus subtilis DE111® is a safe, well-tolerated commercially available spore-forming probiotic that has been clinically shown to support a healthy gut microbiome, and to promote digestive and immune health in both adults and children. Recently it was shown that this spore-forming probiotic was capable of germinating in the gastrointestinal tract as early as 3 h after ingestion. However, a better understanding of the mechanisms involved in the efficacy of DE111® is required. Therefore, the present investigation was undertaken to elucidate the functional properties of DE111® through employing a combination of in vitro functional assays and genome analysis. DE111® genome mining revealed the presence of several genes encoding acid and stress tolerance mechanisms in addition to adhesion proteins required to survive and colonize harsh gastrointestinal environment including multi subunit ATPases, arginine deiminase (ADI) pathway genes (argBDR), stress (GroES/GroEL and DnaK/DnaJ) and extracellular polymeric substances (EPS) biosynthesis genes (pgsBCA). DE111® harbors several genes encoding enzymes involved in the metabolism of dietary molecules (protease, lipases, and carbohyrolases), antioxidant activity and genes associated with the synthesis of several B-vitamins (thiamine, riboflavin, pyridoxin, biotin, and folate), vitamin K2 (menaquinone) and seven amino acids including five essential amino acids (threonine, tryptophan, methionine, leucine, and lysine). Furthermore, a combined in silico analysis of bacteriocin producing genes with in vitro analysis highlighted a broad antagonistic activity of DE111® toward numerous urinary tract, intestinal, and skin pathogens. Enzymatic activities included proteases, peptidases, esterase's, and carbohydrate metabolism coupled with metabolomic analysis of DE111® fermented ultra-high temperature milk, revealed a high release of amino acids and beneficial short chain fatty acids (SCFAs). Together, this study demonstrates the genetic and phenotypic ability of DE111® for surviving harsh gastric transit and conferring health benefits to the host, in particular its efficacy in the metabolism of dietary molecules, and its potential to generate beneficial SCFAs, casein-derived bioactive peptides, as well as its high antioxidant and antimicrobial potential. Thus, supporting the use of DE111® as a nutrient supplement and its pottential use in the preparation of functional foods.

Project description:AbstractDurable spore-forming probiotics are increasingly formulated into foods, beverages, and dietary supplements. To help meet this demand, the safety and efficacy of daily supplementation of Bacillus subtilis BS50 for 6 weeks was investigated in a randomized, double-blind, placebo-controlled, parallel clinical trial of 76 healthy adults. Before and during supplementation, gastrointestinal symptoms were recorded daily using a multi-symptom questionnaire. Clinical chemistry, hematology, plasma lipids, and intestinal permeability and inflammation markers were measured at baseline and end of study. Compared to placebo, 2 × 109 colony-forming units (CFU) BS50 per day increased the proportion of participants showing improvement from baseline to week 6 in the composite score for bloating, burping, and flatulence (47.4% vs. 22.2%), whereby the odds of detecting an improvement were higher with BS50 (OR [95% CI]: 3.2 [1.1, 8.7], p = .024). Analyses of individual gastrointestinal symptoms indicate that BS50 increased the proportion of participants showing an improvement at week 6 compared to placebo for burping (44.7% vs. 22.2%, p = .041) and bloating (31.6% vs. 13.9%, p = .071), without affecting other symptoms. There were no clinically meaningful changes in clinical chemistry, hematology, plasma lipids and intestinal permeability and other inflammation markers. In conclusion, the results suggest that dietary supplementation of 2 × 109 CFU Bacillus subtilis BS50 per day is a well-tolerated and safe strategy to alleviate gas-related gastrointestinal symptoms in healthy adults.AbbreviationsAE adverse event; BHD bowel habits diary; BMI body mass index; BSS Bristol Stool Scale; CFU colony-forming unit; CRP C-reactive protein; FGID functional gastrointestinal disorder; GI gastrointestinal; GITQ Gastrointestinal Tolerance Questionnaire; GLP-1 glucagon-like peptide 1; GSRS Gastrointestinal Symptom Rating Scale; HDL-C high-density lipoprotein-cholesterol; IBS irritable bowel syndrome; IL-10 interleukin-10; ITT intent-to-treat; LBP lipopolysaccharide binding protein; LDL-C low-density lipoprotein-cholesterol; PP per protocol; PYY peptide YY; TG triglyceride; total-C total cholesterol.

Project description:Coccidiosis is a well-known poultry disease that causes the severe destruction of the intestinal tract, resulting in reduced growth performance and immunity, disrupted gut homeostasis and perturbed gut microbiota. Supplementation of probiotics were explored to play a key role in improving growth performance, enhancing innate and adaptive immunity, maintaining gut homeostasis and modulating gut microbiota during enteric infection. This study was therefore designed to investigate the chicken gut whole microbiota responses to Bacillus subtilis (B. subtilis) probiotic feeding in the presence as well as absence of Eimeria infection. For that purpose, 84 newly hatched chicks were assigned into four groups, including (1) non-treated non-challenged control group (CG - ET), (2) non-treated challenged control group (CG + ET), (3) B. subtilis-fed non-challenged group (BS - ET) and (4) B. subtilis-fed challenged group (BS + ET). CG + ET and BS + ET groups were challenged with Eimeria tenella (E. tenella) on 21 day of housing. Our results for Alpha diversity revealed that chickens in both infected groups (CG + ET and BS + ET) had lowest indexes of Ace, Chao 1 and Shannon, while highest indexes of Simpson were found in comparison to non-challenged groups (CG - ET and BS - ET). Firmicutes was the most affected phylum in all experimental groups following Proteobacteria and Bacteroidota, which showed increased abundance in both non-challenged groups, whereas Proteobacteria and Bacteroidota affected both challenged groups. The linear discriminant analysis effect size method (lEfSe) analysis revealed that compared to the CG + ET group, supplementation of probiotic in the presence of Eimeria infection increased the abundance of some commensal genera, included Clostridium sensu stricto 1, Corynebacterium, Enterococcus, Romboutsia, Subdoligranulum, Bacillus, Turicibacter and Weissella, with roles in butyrate production, anti-inflammation, metabolic reactions and the modulation of protective pathways against pathogens. Collectively, these findings evidenced that supplementation of B. subtilis probiotic was positively influenced with commensal genera, thereby alleviating the Eimeria-induced intestinal disruption.

Project description:The use of bacterial spores in probiotics over viable loads of bacteria has many advantages, including the durability of spores, which allows spore-based probiotics to effectively traverse the various biochemical barriers present in the gastrointestinal tract. However, the majority of spore-based probiotics developed currently aim to treat adults, and there is a litany of differences between the adult and infant intestinal systems, including the immaturity and low microbial species diversity observed within the intestines of infants. These differences are only further exacerbated in premature infants with necrotizing enterocolitis (NEC) and indicates that what may be appropriate for an adult or even a healthy full-term infant may not be suited for an unhealthy premature infant. Complications from using spore-based probiotics for premature infants with NEC may involve the spores remaining dormant and adhering to the intestinal epithelia, the out-competing of commensal bacteria by spores, and most importantly the innate antibiotic resistance of spores. Also, the ability of Bacillus subtilis to produce spores under duress may result in less B. subtilis perishing within the intestines and releasing membrane branched-chain fatty acids. The isolate B. subtilis BG01-4TM is a proprietary strain developed by Vernx Biotechnology through accumulating mutations within the BG01-4TM genome in a serial batch culture. Strain BG01-4TM was provided as a non-spore-forming B. subtilis , but a positive sporulation status for BG01-4TM was confirmed through in vitro testing and suggested that selection for the sporulation defective genes could occur within an environment that would select against sporulation. The durability of key sporulation genes was ratified in this study, as the ability of BG01-4TM to produce spores was not eliminated by the attempts to select against sporulation genes in BG01-4TM by the epigenetic factors of high glucose and low pH. However, a variation in the genes in isolate BG01-4-8 involved in the regulation of sporulation is believed to have occurred during the mutation selection from the parent strain BG01-4TM. An alteration in selected sporulation regulation genes is expected to have occurred from BG01-4TM to BG01-4-8, with BG01-4-8 producing spores within 24 h, ~48 h quicker than BG01-4TM.

Dataset Information

Presence and Germination of the Probiotic Bacillus subtilis DE111^® in the Human Small Intestinal Tract: A Randomized, Crossover, Double-Blind, and Placebo-Controlled Study.

Publications

Presence and Germination of the Probiotic <i>Bacillus subtilis</i> DE111<sup>®</sup> in the Human Small Intestinal Tract: A Randomized, Crossover, Double-Blind, and Placebo-Controlled Study.

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