Digestive Advantage brand products are over-the-counter, drug-free medical foods and dietary supplements that contain the probiotic bacteria GanedenBC30, which can help manage a variety of symptoms associated with Irritable Bowel Syndrome, Lactose Intolerance, constipation, intestinal gas and Crohn’s & Colitis.
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Clinical Studies
Bacillus coagulans Significantly Improved Abdominal Pain and Bloating in Patients with IBS
Postgraduate Medicine, Vol. 121, Issue 2, March 2009
Larysa Hun, MD, FAAP
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
A Patented Strain of Bacillus coagulans Increased Immune Response to Viral Challenge
Postgraduate Medicine, Vol. 121, Issue 2, March 2009
Mira Baron, MD
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-? 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
A prospective, randomized, double-blind, placebo-controlled parallel-group dual site trial to evaluate the effects of a Bacillus
coagulans-based product on functional intestinal gas symptoms
Douglas S Kalman, Howard I Schwartz, Patricia Alvarez, Samantha Feldman, John C Pezzullo and Diane R Krieger
Abstract:
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 -
(GanedenBC30 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. Conclusions: 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 gasrelated symptoms and no GI diagnoses.
Effects of a proprietary Bacillus coagulans preparation on symptoms of diarrhea-predominant irritable bowel syndrome.
Dolin BJ.
Abstract:
Symptoms of irritable bowel syndrome (IBS) have a profound impact on quality of life for many patients and current treatments are sometimes unsatisfactory. This controlled pilot study was conducted to evaluate effects of the proprietary GanedenBC30 (Bacillus coagulans GBI-30, 6086) probiotic on IBS symptoms, in a randomized, double-blind, placebo-controlled clinical trial including patients with diarrhea-predominant IBS (IBS-D). Patients were randomized to receive either B. coagulans GBI-30, 6086 or placebo once a day for 8 weeks. Patients filled out a quality-of-life questionnaire, and self-assessment diaries were provided to record stool count and consistency, symptom severity, and medication consumption. Of the 61 patients enrolled, six did not meet the inclusion criteria and three were lost to follow-up. Of the remaining 52 patients with IBS-D, the average number of bowel movements per day was significantly reduced for patients treated with B. coagulans GBI-30, 6086 when compared to placebo (P = 0.042). Large variability in baseline scores prevented the assessment of severity scores and quality of life. This small pilot study provides evidence that the proprietary B. coagulans GBI-30, 6086 probiotic is safe and effective for reducing daily bowel movements in patients with IBS-D.
Survival and metabolic activity of the GanedenBC30 strain of Bacillus coagulans in a dynamic in vitro model of the stomach and small intestine.
Beneficial Microbes 1 (1): 31-36.
Maathuis, A.J.H., et al., 2010.
We have investigated the survival and activity of GanedenBC30 during passage through the upper gastro-intestinal tract. GanedenBC30 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 GanedenBC30 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 GanedenBC30 was added to the milk. When GanedenBC30 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 GanedenBC30 alone. In conclusion, although the differences in survival of GanedenBC30 are small, these results show the potential of GanedenBC30 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 GanedenBC30 to aid in the digestion of lactose and fructose could be used to prevent occurrence of intestinal symptoms in individuals sensitive to these carbohydrates.
Bacillus coagulans: a viable adjunct therapy for relieving symptoms of rheumatoid arthritis according to a randomized, controlled trial.
BMC Complementary and Alternative Medicine 2010 Jan 12; 10:1
Mandel, D.R., et al., 2010.
Background: Lactic acid-producing bacteria (LAB) probiotics demonstrate immunomodulating and anti-inflammatory effects and the ability to lessen the symptoms of arthritis in both animals and humans. This randomized, double-blind, placebo-controlled, parallel-design, clinical pilot trial was conducted to evaluate the effects of the LAB probiotic preparation, Bacillus coagulans GBI-30, 6086, on symptoms and measures of functional capacity in patients with rheumatoid arthritis (RA) in combination with pharmacological anti-arthritic medications. Methods: Forty-five adult men and women with symptoms of RA were randomly assigned to receive Bacillus coagulans GBI-30, 6086 or placebo once a day in a double-blind fashion for 60 days in addition to their standard anti-arthritic medications. Arthritis activity was evaluated by clinical examination, the American College of Rheumatology (ACR) criteria, the Stanford Health Assessment Questionnaire Disability Index (HAQDI), and laboratory tests for erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Results: Subjects who received Bacillus coagulans GBI-30, 6086 experienced borderline statistically significant improvement in the Patient Pain Assessment score (P = 0.052) and statistically significant improvement in Pain Scale (P = 0.046) vs. placebo. Compared with placebo, Bacillus coagulans GBI-30, 6086 treatment resulted in greater improvement in patient global assessment and self-assessed disability; reduction in CRP; as well as the ability to walk 2 miles, reach, and participate in daily activities. There were no treatment-related adverse events reported throughout this study. Conclusions: Results of this pilot study suggest that adjunctive treatment with Bacillus coagulans GBI-30, 6086 LAB probiotic appeared to be a safe and effective for patients suffering from RA. Because of the low study population size, larger trials are needed to verify these results.
GanedenBC30 cell wall and metabolites:
anti-inflammatory and immune modulating effects in vitro
BMC Immunology 2010 11:15
Gitte S Jensen, Kathleen F Benson, Steve G Carter, John R Endres
Background: This study was performed to evaluate anti-inflammatory and immune modulating properties of the probiotic, spore-forming bacterial strain: Bacillus coagulans: GBI-30, (PTA-6086, GanedenBC30 ). In addition, cell wall and metabolite fractions were assayed separately to address whether biological effects were due to cell wall components only, or whether secreted compounds from live bacteria had additional biological properties. The spores were heat-activated, and bacterial cultures were grown. The culture supernatant was harvested as a source of metabolites (MTB), and the bacteria were used to isolate cell wall fragments (CW). Both of these fractions were compared in a series of in vitro assays. Results: Both MTB and CW inhibited spontaneous and oxidative stress-induced ROS formation in human PMN cells and increased the phagocytic activity of PMN cells in response to bacteria-like carboxylated fluorospheres. Both fractions supported random PMN and f-MLP-directed PMN cell migration, indicating a support of immune surveillance and antibacterial defense mechanisms. In contrast, low doses of both fractions inhibited PMN cell migration towards the inflammatory mediators IL-8 and LTB4. The anti-inflammatory activity was strongest for CW, where the PMN migration towards IL-8 was inhibited down to dilutions of 1010. Both MTB and CW induced the expression of the CD69 activation marker on human CD3- CD56+ NK cells, and enhanced the expression of CD107a when exposed to K562 tumor cells in vitro. The fractions directly modulated cytokine production, inducing production of the Th2 cytokines IL-4, IL-6, and IL-10, and inhibiting production of IL-2.
Both fractions further modulated mitogen-induced cytokine production in the following manner: Both fractions enhanced the PHA-induced production of IL-6 and reduced the PHA-induced production of TNF-alpha. Both fractions enhanced the PWM-induced production of TNF-alpha and IFN-gamma. In addition, MTB also enhanced both the PHA- and the PWM-induced expression of IL-10.
Conclusion: The data suggest that consumption of GanedenBC30 may introduce both cell wall components and metabolites that modulate inflammatory processes in the gut. Both the cell wall and the supernatant possess strong immune modulating properties in vitro. The anti-inflammatory effects, combined with direct induction of IL- 10, are of interest with respect to possible treatment of inflammatory bowel diseases as well as in support of a healthy immune system.Read the complete study online
A controlled clinical trial to evaluate the effects of GanedenBC30 on immunological markers.
Methods Find Exp Clin Pharmacol, 32(2) 129-132
Kimmel M. et al. 2010
GanedenBC30®, a probiotic, has been shown to significantly increase T-cell production of TNF-? after ex vivo exposure to a strain of adenovirus (AdenoVI) or Influenza A (H3N2 Texas strain [FluTex]). The current controlled study was designed to further evaluate the effects of GanedenBC30 on immunological marker levels following viral exposure. Ten healthy subjects’ baseline immunological marker levels were analyzed. Subjects consumed 1 capsule/day of GanedenBC30 for 28 days and returned for post-treatment immunological marker evaluation. Subjects’ baseline measurements served as their own control. All subjects completed the study with no adverse events; however, one subject was excluded from the final analysis based on a reasonable consideration as an outlier. CD3+CD69+ cells, IL-6, IL-8, interferon-? (IFN-?) and TNF-? levels were increased after exposure to AdenoVI and FluTex. IL-1? levels also increased after exposure to AdenoVI but were decreased after ex vivo exposure to FluTex. CD3+CD69+ cells increased significantly (P= 0.023) after exposure to both viral strains. Differences in IL-8 levels after FluTex exposure achieved statistical significance (P= 0.039) as did IFN-? levels after AdenoVI exposure (P= 0.039). A regimen of one capsule per day continaing 500 million CFU of GanedenBC30 may be a safe and effective option for enhancing the immunological response to common viral respiratory tract infections.
Proven Safety
Safety assessment of a proprietary preparation of a novel Probiotic, Bacillus coagulans, as a food ingredient
Food and Chemical Toxicology
J.R. Endres, A. Clewell, K.A. Jade, A.G. Schauss — AIBMR Life Sciences Inc., 4117 South Meridian, Puyallup WA 98373, USA
T. Farber — ToxaChemica, International, 11430 Strand Drive, Rockville MD 20852, USA
J. Hauswirth - Van Gemert and Hauswirth, LLC, 3222 Green Forest Ct., Ellicott City MD 21042, USA
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.
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.
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