A Patented Strain of Bacillus coagulans Increased Immune Response to Viral Challenge

Abstract:
Background: Viral respiratory tract infection is the most common illness among humans. Probiotics have been known to enhance the immune system and, therefore, may represent a significant therapeutic advancement for treating viral respiratory tract infections. Objective: A controlled study was conducted to evaluate the effects of the patented GanedenBC³⁰ probiotic (Bacillus coagulans GBI-30, 6086, marketed as Sustenex^®[Ganeden Biotech, Inc., Mayfield Heights, OH]) on the immune system when exposed to adenovirus and influenza in otherwise healthy adults. Methods: Ten healthy men and women (average age, 44 years) were instructed to consume 1 capsule of GanedenBC³⁰ with water once a day for 30 days. At baseline and after completion of the 30-day treatment, blood levels of cytokines were measured in vitro after T-cell exposure to adenovirus and influenza A. Each participant served as his/her own control with baseline blood draw. Results: The use of GanedenBC³⁰ significantly increased T-cell production of TNF-α in response to adenovirus exposure (P = 0.027) and influenza A (H3N2 Texas strain) exposure (P = 0.004), but it did not have a significant effect on the response to other strains of influenza. No serious adverse events were reported throughout the study. Conclusions: The patented GanedenBC³⁰ probiotic may be a safe and effective therapeutic option for enhancing T-cell response to certain viral respiratory tract infections.

To read the complete study online visit Postgraduate Medicine

Bacillus coagulans Significantly Improved Abdominal Pain and Bloating in Patients with IBS

Abstract:
Background: Symptoms of irritable bowel syndrome (IBS) can have a profound impact on emotional health and quality of life, and current treatments are sometimes unsatisfactory for patients facing this lifelong disease. Probiotics, which can normalize gastrointestinal microflora, may alleviate symptoms of IBS. Objective: This preliminary controlled study was conducted to evaluate the effects of the probiotic Bacillus coagulans GBI-30, 6086 on IBS symptoms. Methods: This was a randomized, double-blind, parallel-group, placebo-controlled clinical trial involving 44 subjects who received either placebo or B coagulans GBI-30, 6086 once a day for 8 weeks. Self-assessments of the severity of IBS symptoms (abdominal pain and bloating) were recorded every day for 8 weeks. Because baseline values were significantly different between the 2 study groups, within-group analysis was conducted. Results: Improvements from baseline abdominal pain and bloating scores in the B coagulans GBI-30, 6086 group were statistically significant for all 7 weekly comparisons (P < 0.01). In the placebo group, only changes in abdominal pain scores at weeks 6 and 8 achieved statistical significance (P < 0.05). No treatment-related adverse events or serious adverse events were reported during the 8-week study period. Conclusions: Preliminary data suggest that the patented B coagulans GBI-30, 6086 probiotic may be a safe and effective option for the relief of abdominal pain and bloating for patients with IBS. Larger, extended trials are needed to verify these results.

To read the complete study online visit Postgraduate Medicine

GanedenBC³⁰ (Bacillus coagulans)

Purpose
To determine the survivability rate of GanedenBC³⁰ (Bacillus coagulans) spores as they would pass through the stomach.

Proven Safety

Safety assessment of a proprietary preparation of a novel Probiotic, Bacillus coagulans, as a food ingredient

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 – GanedenBC30™ – 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 GanedenBC30™ 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 × 1011 CFUs/g, this corresponds to 95.2 × 1011 CFUs for a 70 kg human and since the suggested human dose is in the range of 100 × 106 to 3 × 109 CFUs, this gives a safety factor ranging from 3173 to 95,200 times. Based upon scientific procedures and supported by history of use, GanedenBC30™ is considered safe for chronic human consumption.

Read the complete study online