Evaluation of Bacillus clausii CSI08, Bacillus megaterium MIT411 and a Bacillus cocktail on gastrointestinal health: a randomised, double-blind, placebo-controlled pilot study

Abstract

In the present study, the safety, tolerance and impact of 1×109 cfu Bacillus clausii CSI08, 1×109 cfu Bacillus megaterium MIT411 and a probiotic cocktail containing Bacillus subtilis DE111®, Bacillus megaterium MIT411, Bacillus coagulans CGI314, and Bacillus clausii CSI08 with a total count of 2.0×109 cfu administered daily were assessed as compared with a maltodextrin containing placebo control. A total of 98 study participants received daily doses for 45 days, followed by a washout period of 2 weeks. A questionnaire to capture the incidence and duration of upper respiratory tract, urinary tract and/or gastrointestinal complaints and a diary to capture stool regularity and consistency was kept daily to record compliance throughout the 45 days. Faecal and blood samples were collected for microbiological and haematological analysis at the start and end of the treatment period. The probiotic cocktail significantly decreased the incidence of loose stools throughout the entire study. The recorded respiratory, urinary and gastrointestinal symptoms, defecation frequency and other stool consistency were not influenced. No clinically relevant changes in blood parameters, such as liver and kidney function and no serious adverse events appeared during and after administration. There were no changes in symptoms including sadness, irritability, energy, appetite, tension, stress, sleep, cardiovascular events, aches and pains, and dizziness as determined by a mood questionnaire administered to participants at baseline and at the end of the treatment period. Similarly, the measured inflammatory cytokines, antioxidant levels, cholesterol, triglycerides, free amino acids or minerals remained unaffected. There were no negative changes in alpha or beta diversity of the microbiota with any of the treatment groups. These promising data suggest that these treatments were safe and well tolerated, and further work with larger cohorts are justified to determine the efficacy of these potential probiotics in select demographic groups. Trial registration number with clinicaltrials.gov at NCT 04758845.

Overview of Probiotic Strains of Weizmannia coagulans, Previously Known as Bacillus coagulans, as Food Supplements and Their Use in Human Health

“…A total of 53 clinical studies on humans were found. Two cross-over studies [31,32], five studies that included various Weizmannia coagulans (previously Bacillus coagulans) strains as part of multi-strain probiotics [33][34][35][36][37] and twenty-five randomised controlled trials that included various Weizmannia coagulans (previously Bacillus coagulans) as single strain probiotics [24,25, are described in the results in tabular form. Then, 21 studies are described only descriptively; of these, 2 [61,62] were not placebo-controlled studies and 19 studies contained no strain information [63][64][65][66][67][68][69][70][71][72][73][74][75][76][77][78][79][80][81].…”

“…The beneficial effect was connected to intestinal microbiota modulation. Five randomised controlled clinical trials [33][34][35][36][37] included various strains of Weizmannia coagulans (previously Bacillus coagulans) such as CGI314, Unique IS2, MY01, and SNZ 1969 as part of multi-strain probiotics. Safety and tolerance as well as the effect of examination stress on students, influence on functional dyspepsia symptoms, gastrointestinal discomfort, and overweight and obesity-related parameters were investigated and statistically significant health benefits were found in all clinical trials with multi-strain probiotics.…”

Fecal virus transplantation has more moderate effect than fecal microbiota transplantation on changing gut microbial structure in broiler chickens

“…At 21 days old, there was a significant negative correlation between Ruminococcus and PepT-1 expression, while PepT-1 expression did not accordance with the Ruminococcus abundance. Therefore, a single type of microbe may not be the reason leading to transporter changing ( Rea et al, 2023 ). There were 2 hypotheses.…”

Spore-Based Probiotic Bacillus subtilis: Current Applications in Humans and Future Perspectives

“…While, B. subtilis has been investigated as a component of multi-species probiotics in several recent clinical trials [42][43][44][45], these studies are not included in the current review. Instead, we comprehensively summarize studies examining the effects of different strains of B. subtilis administered as a single-organism probiotic (Figure 2).…”