Deerland’s spore-forming DE111 probiotic germinates human GI tract in first-of-its-kind study

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Deerland Probiotics & Enzymes (Kennesaw, GA) says a new, first-of-its-kind human study showed that its spore-forming probiotic strain Bacillus subtilis DE111 survived and germinated the human gastrointestinal tract.¹ This clinical study is the first to show germination of a spore-forming probiotic in vivo, the firm says.

The study used a novel design. The randomized, crossover, double-blind, placebo-controlled study, included 11 ileostomy subjects. An ileostomy “involves the disconnection of the small intestine from the colon and reconnection to an external ileal bag,” the firm explained in a press release.

During the study, subjects received either a 1) breakfast meal plus placebo, or 2) a breakfast meal plus a supplement containing DE111 B. subtilis spores (5 × 10⁹ CFU). There was a one-week washout period after which subjects switched to the other protocol.

Participants emptied their ileostomy pouch into a sample collection bag for analysis. “With access to the contents of the ileal bags, investigators were able to directly examine spore germination under real-time in vivo conditions in the human small intestine for the first time,” the firm says.

The results showed that DE111 did in fact germinate the small intestine. Six hours after ingestion, DE111 subjects saw an CFU increase of 9.7 × 10⁷ ± 8.1 × 10⁷ CFU/g, which remained constant to the final time point of eight hours. Vegetative cells reached a concentration of 7.3 × 10⁷ ± 1.4 × 10⁸ CFU/g at seven hours following ingestion.

Said the researchers, “During the study period of 8 hours—the average time for food to fully travel from the mouth all the way through the small intestines—the combined DE111 spore and DE111 vegetative cell counts emanating from the ileum were the same or more than the number of spores that were consumed at the beginning of the study. This indicates excellent survivability of DE111 as well as growth and reproduction of the strain in the digestive tract.”

They added: “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 three hours of ingestion.”

This study provides further support for the value of spore-forming probiotic strains. Said the researchers, “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.”

“Germination of spore-forming probiotics in the small intestines is of particular importance considering that a significant portion of the immune system is located in that portion of the gut and the majority of digestion and nutrient absorption occurs there,” explained John Deaton, vice president of science and technology for Deerland Probiotics & Enzymes, in the press release. “Prior to this new study, others have attempted to determine spore germination in the small intestine through simulated lab models or animal studies, but none have investigated actual in vivo spore germination in the human small intestine.”

Deaton added, “This study provides clear evidence that DE111 spores germinate in the human small intestine. This then provides support to show that consuming B. subtilis DE111 effectively promotes and supports immune and digestive health.”

The researchers said longer studies, with an extended intervention period, would help add further insight into the efficacy, metabolic activity, colonization, and re-sporulation of DE111.

Reference

1. Colom J et al. “Presence and germination of the probiotic Bacillus subtilis DE111® in the human small intestinal tract: A randomized, crossover, double-blind, and placebo-controlled study.” Frontiers in Microbiology. Published online August 2, 2021.