Background This randomized double blind placebo controlled dual site clinical trial compared a probiotic dietary supplement to placebo regarding effects on gastrointestinal symptoms in adults with post-prandial intestinal gas-related symptoms (abdominal pain, distention, flatulence) but no gastrointestinal (GI) diagnoses to explain the symptoms. Methods: Sixty-one adults were enrolled (age 36.5 ± 12.6 years; height 165.1 ± 9.2 cm; weight 75.4 ± 17.3 kg) and randomized to either Digestive Advantage Gas Defense Formula - (BC30 Bacillus coagulans GBI-30, 6086): n = 30; or Placebo: n = 31. Study subjects were evaluated every two weeks over a four-week period using validated questionnaires and standard biochemical safety testing. Outcome criteria of interest included change from baseline in Gastrointestinal Symptom Rating Scale (GSRS) abdominal pain, abdominal distention, flatus, and the Severity of Dyspepsia Assessment (SODA) bloating and gas subscores over four weeks of product use. Results: Measured against the placebo, subjects in the probiotic group achieved significant improvements in GSRS abdominal pain subscore (p = 0.046) and the GSRS total score (p = 0.048), with a strong trend for improvement on the GSRS abdominal distension subscore (p = 0.061). A strong placebo effect was evident which could explain the lack of statistical significant differences between the groups for many of the efficacy variables. Conclusion: In conclusion, the Bacillus coagulans-based product was effective in improving the quality of life and reducing gastrointestinal symptoms in adults with post-prandial intestinal gas-related symptoms and no GI diagnoses.
Background We have investigated the survival and activity of BC30 during passage through the upper gastrointestinal tract. BC30 was tested in a dynamic, validated, in vitro model of the stomach and small intestine (TIM-1) on survival and its potential to aid in digestion of milk protein, lactose and fructose. The survival of BC30 was high (70%), although germination of the spores was minimal (<10%) under the conditions tested. Survival of the strain in the presence of lactose and fructose was markedly lower (56-59%) than in the absence of the sugars. The amount of digested milk protein available for absorption was somewhat higher (+0.2 g) when BC30 was added to the milk. When BC30 was tested with lactose or fructose added to the meal, the cumulative amount of lactate produced was slightly higher (+0.12-0.18 mmol) compared to the BC30 alone. In conclusion, although the differences in survival of BC30 are small, these results show the potential of BC30 to aid in protein digestion and in the digestion of lactose and fructose. If a larger fraction of the Bacillus coagulans cells had germinated, the influence on protein and carbohydrate digestion would probably have been much greater. Importance of the findings: the potential of BC30 to aid in the digestion of lactose and fructose could be used to prevent occurrence of intestinal symptoms in individuals sensitive to these carbohydrates
Purpose
To determine the survivability rate of BC30 (Bacillus coagulans) spores as they would pass through the stomach.
J.R. Endres, A. Clewella, K.A. Jade, A.G. Schaussa
T. Farber - ToxaChemica, International
J. Hauswirth - Van Gemert and Hauswirth, LLC
Abstract:
It has been demonstrated that some strains of Bacillus coagulans can survive extremes of heat, acidity of the stomach, and bile acids, to which commonly consumed probiotics are susceptible. A toxicological safety assessment was performed on a proprietary preparation of B.coagulans - BC30 - a novel probiotic. Seven toxicologic studies were conducted and included: in vitro bacterial reverse mutation assay; in vitro chromosomal aberration assay; micronucleus assay in mice; acute and 90 day subchronic repeated oral toxicity studies were conducted in Wistar Crl:(WI) BR rats; acute eye and skin irritation studies were conducted in rabbits.
Results:
The results of this toxicological safety assessment indicate that BC30 B.coagulans does not demonstrate mutagenic, clastogenic, or genotoxic effects. Furthermore, the results of the acute and 90-day subchronic oral toxicity studies in rats resulted in the conclusion of a NOAEL greater than 1000 mg/kg per day. Since the concentration of the cell mass used in the 90-day study was 1.36 x 1011 CFUs/g, this corresponds to 95.2 x 1011 CFUs for a 70 kg human and since the suggested human dose is in the range of 100 x 106 to 3 x 109 CFUs, this gives a safety factor ranging from 3173 to 95,200 times. Based upon scientific procedures and supported by history of use, BC30 is considered safe for chronic human consumption.
