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

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 DE111 in the small intestine. Three hours following ingestion of DE111, spores (6.4 × 10 ± 1.3 × 10 CFU/g effluent dry weight) and vegetative cells (4.7 × 10 ± 1.1 × 10 CFU/g effluent dry weight) began to appear in the ileum effluent. Six hours after ingestion, spore concentration increased to 9.7 × 10 ± 8.1 × 10 CFU/g and remained constant to the final time point of 8 h. Vegetative cells reached a concentration of 7.3 × 10 ± 1.4 × 10 CFU/g at 7 h following ingestion. These results reveal orally ingested 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.