Data from a randomized, double-blind, placebo-controlled, parallel clinical trial of 76 healthy adults indicated that 45% of participants showed an improvement after six weeks of supplementation with Bio-Cat’s Bacillus subtilis BS50, compared 22% of the placebo group.
A greater proportion of people in the BS50 group also displayed improvements in bloating scores (32%), compared to placebo, according to findings published in Gut Microbes.
“Results from this first-in-human study of the probiotic strain Bacillus subtilis BS50 demonstrate that daily supplementation at 2 × 109 CFU/day increased the proportion of participants showing improvement in the composite score for bloating, burping, and flatulence, compared to placebo. BS50 also improved the individual symptoms of bloating and burping across the 6 weeks of daily probiotic supplementation,” wrote the researchers from Bio-Cat and Biofortis Inc.
“These results suggest that B. subtilis BS50 supplementation is a well-tolerated and safe probiotic approach to improve digestive health, support GI comfort, and alleviate gas-related GI symptoms in healthy adults.”
Bio-Cat’s BS50 strain is part of the company’s OptiBiome range of probiotics. The Virginia-based company was founded in 2004 and focuses on human, animal, and crop nutrition.
Probiotics for the dietary supplement industry are produced by Bio-Cat under exclusive licensing agreements, in addition to the company’s 9 AAFCO approved strains utilized in the companion and production animal nutrition markets. All strains are manufactured at the company’s fermentation facility in Shakopee, MN.
Commenting on the new study, co-founder and CEO Chris Schuler, said: "I'm proud of our R&D team for their swift execution in taking this strain from ideation to market readiness.”
The new study included 76 healthy people with an average age of 50 and an average BMI of 25.8 kg/m2. The participants were randomly assigned to receive either two billion colony-forming units (CFU) per day of BS50 or placebo for six weeks.
The data showed that BS50 led to significant improvements from baseline to week 6 in the composite score for bloating, burping, and flatulence, while a greater proportion of people in the BS50 group had improvements in bloating and burping, compared to placebo.
However, no effects were observed following BS50 supplementation on the number of bowel movements, stool consistency, and bowel movement-related symptoms.
Importantly, the researchers also found that there no clinically meaningful changes in clinical chemistry, hematology, plasma lipids, intestinal permeability, or other inflammation markers, thereby supporting the safety and tolerability of the strain.
“Although the exact mechanism by which BS50 improved GI symptoms remains unknown, it is likely dependent on the transition of BS50 spores to vegetative cells in the stomach and small intestine,” wrote the researchers. “Vegetative BS50 has been shown to secrete digestive enzymes in vitro.
“Taken together, BS50 may germinate in the intestine and secrete enzymes that help digest food and improve nutrient absorption, theoretically leading to less fermentation and gas production in the lower intestine.”
Source: Gut Microbes
“The probiotic Bacillus subtilis BS50 decreases gastrointestinal symptoms in healthy adults: a randomized, double-blind, placebo-controlled trial”
Authors: S.M. Garvey et al.