Furqan Ali

A Double-Blind, Placebo-Controlled, Parallel Study Evaluating the Safety ofBacillus coagulans MTCC 5856 in Healthy Individuals

Objective: LactoSpore® containing probiotic strain Bacillus coagulans MTCC 5856 has been marketed as a dietary ingredient for nearly two decades. Clinical data on the safety and tolerance has not been evaluated at a dose of 2×109 cfu (spores)/day in healthy individuals. Thus, the primary objective of this study was to investigate the safety and tolerability of B. coagulans MTCC 5856 in healthy adults. Study design: A total of 40 participants were randomized into one of two groups in a double-blind, randomized, placebo-controlled parallel study. One group of participants (n=20) were administered B. coagulans MTCC 5856 (600 mg tablet), containing 2×109 cfu (spores). The control group (n=20) was administered placebo tablets. Safety and tolerability of B. coagulans MTCC 5856 was assessed over 30 days by safety laboratory parameters (blood hematology and clinical chemistry parameters), anthropometric measures (weight, BMI, blood pressure and heart rate), adverse events, Bristol stool score, tolerability questionnaire and bowel habit diary. Results: All laboratory parameters, anthropometric and vital sign measures remained within normal clinical range during the 30 day supplementation. Similar adverse events (AE’s) were reported by participants in both the placebo and the B. coagulans MTCC 5856 group. The number of bowel movements and the Bristol stool scores were similar between the placebo group and B. coagulans MTCC 5856 group during the 30 days of supplementation. Participants also reported that B. coagulans MTCC 5856 tablets were tolerable and easy to swallow. Conclusions: This study has verified that B. coagulans MTCC 5856 at a dose of 2 × 109 cfu (spores)/day was safe and tolerable in healthy participants when supplemented for 30 days.

Galactomannan from Trigonella foenum-graecum L. seed: Prebiotic application and its fermentation by the probiotic Bacillus coagulans strain MTCC 5856

Abstract Health benefits of dietary fibers are currently being widely recognized. However, the assessment of dietary fiber as a prebiotic is essential and also important for the development of an improved synbiotic commercial preparation. Thus, the aim of this study was to evaluate the potential of galactomannan extracted from fenugreek seeds as a prebiotic fiber and also its fermentation by the probiotic strain Bacillus coagulans MTCC 5856. Nondigestibility by the gastric acid and pancreatic enzyme hydrolysis of galactomannan were determined using an in vitro model mimicking the in vivo conditions. Further, anaerobic fermentation and utilization of galactomannan by the B. coagulans MTCC 5856 was investigated followed by selective inhibition of Escherichia coli ATCC 25922. The galactomannan from fenugreek seeds was found to be nondigestible to gastric acid and also to pancreatic enzymatic hydrolysis. The galactomannan was fermented and utilized (71.4%) by the B. coagulans MTCC 5856, and also significant amount of short‐chain fatty acids production was also observed. Furthermore, B. coagulans MTCC 5856 inhibited the E. coli ATCC 25922 growth when cocultured with galactomannan suggesting competitive fermentation of probiotic bacteria. Galactomannan exhibited prebiotic activity and also showed suitability with probiotic B. coagulans MTCC 5856 in a synbiotic combination. This study provides the first scientific evidence of galactomannan from fenugreek seeds as a prebiotic that may play an important role in modulating gut flora by acting as substrate to beneficial microbes.

Cranberry seed fibre: a promising prebiotic fibre and its fermentation by the probiotic Bacillus coagulans MTCC 5856

Cranberry, a versatile fruit, is known for nutritional as well as medicinal properties due to the presence of bioactive compounds. However, cranberry fruit has not been fully explored for its prebiotic potential. Therefore, this study was conducted to evaluate prebiotic potential of cranberry seed fibre (CSF) and also evaluate its fermentability by the probiotic strain Bacillus coagulans MTCC 5856. The resistance to gastric acid and porcine pancreatic enzymatic (PPE) hydrolysis of CSF was investigated using an in vitro model. It was found that CSF was resistant to gastric acid and also nondigestible to PPE hydrolysis. CSF as sole nutrition source was evaluated for the fermentability by B. coagulans MTCC 5856. A significant amount of short-chain fatty acids was produced by the B. coagulans MTCC 5856 while fermenting cranberry fibres anaerobically. CSF supported the growth of B. coagulans MTCC 5856 and also inhibited the growth of E. coli ATCC 25922 when cocultured in an anaerobic environment. CSF from the cranberry fruit exhibited prebiotic potential and also found to be fermentable by B. coagulans MTCC 5856. This study provided the scientific evidence of CSF as a prebiotic fibre and also its suitability with the probiotic B. coagulans MTCC 5856 for an ideal synbiotic preparation.

Bacillus coagulans MTCC 5856 for the management of major depression with irritable bowel syndrome: a randomised, double-blind, placebo controlled, multi-centre, pilot clinical study

Background The modification of microbial ecology in human gut by supplementing probiotics may be an alternative strategy to ameliorate or prevent depression. Objective The current study was conducted to assess the safety and efficacy of the probiotic strain Bacillus coagulans MTCC 5856 for major depressive disorder (MDD) in IBS patients. Method Patients (n = 40) diagnosed for MDD with IBS were randomized (1:1) to receive placebo or B. coagulans MTCC 5856 at a daily dose of 2 × 109 cfu (2 billion spores) and were maintained to the end of double-blind treatment (90 days). Changes from baseline in clinical symptoms of MDD and IBS were evaluated through questionnaires. Results Significant change (p = 0.01) in favour of the B. coagulans MTCC 5856 was observed for the primary efficacy measure Hamilton Rating Scale for Depression (HAM-D), Montgomery-Asberg Depression Rating Scale (MADRS), Center for Epidemiological Studies Depression Scale (CES-D) and Irritable bowel syndrome quality of life questionnaire (IBS-QOL). Secondary efficacy measures i.e. Clinical Global Impression-Improvement rating Scale (CGI-I), Clinical Global Impression Severity rating Scale (CGI-S), Gastrointestinal Discomfort Questionnaire (GI-DQ) and Modified Epworth Sleepiness Scale (mESS) also showed significant results (p = 0.01) in B. coagulans MTCC 5856 group compared to placebo group except dementia total reaction scoring. Serum myeloperoxidase, an inflammatory biomarker was also significantly reduced (p < 0.01) when compared with the baseline and end of the study. All the safety parameters remained well within the normal clinical range and had no clinically significant difference between the screening and at the end of the study. Conclusion B. coagulans MTCC 5856 showed robust efficacy for the treatment of patients experiencing IBS symptoms with major depressive disorder. The improvement in depression and IBS symptoms was statistically significant and clinically meaningful. These findings support B. coagulans MTCC 5856 as an important new treatment option for major depressive disorder in IBS patients.

Evaluation of the Safety and Efficacy of a Multienzyme Complex in Patients with Functional Dyspepsia: A Randomized, Double-Blind, Placebo-Controlled Study.

Abstract Functional dyspepsia (FD) is a highly prevalent disorder having nonspecific symptoms and varied pathophysiology. Its treatment remains a challenge as therapeutic options are limited, unsatisfactory, and elusive. Thus, safety and efficacy of DigeZyme®, a proprietary multienzyme complex (MEC), was evaluated as a dietary supplement in FD patients. In this randomized, double-blind, placebo-controlled, parallel-group study, 40 patients were randomly assigned (1:1 ratio) to receive either MEC (50 mg, TID; n = 20) or placebo (n = 20) for 60 days. Reports of adverse or serious adverse events (AEs), abnormal results of vital signs, abnormal findings during physical examination, and abnormal laboratory investigations were monitored closely. Efficacy measures were change in Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ), Nepean Dyspepsia Index-Short Form (NDI-SF), Visual Analog Scale (VAS), Clinical Global Impression Severity Rating Scale (CGI-S), and Glasgow Dyspepsia Severity Score (GDSS) at baseline and follow-up visits on day 15, 30, and 60. Supplementation with MEC was associated with statistically significant differences (P value ranging from .0401 to .0033) in all efficacy parameters compared with placebo. The between-group comparison also revealed that MEC supplement had a significantly greater effect (P < .001) versus placebo. No investigation product-related AEs were reported. There were no clinically significant abnormalities in physical findings and no statistically significant changes in biochemical and hematological parameters, vital signs, body weight, and body mass index observed between the two groups at baseline and follow-up visits. MEC supplementation represents an effective and safe alternative to manage dyspepsia symptoms in FD patients.

Evaluation of the in vitro cholesterol-lowering activity of the probiotic strain Bacillus coagulansMTCC 5856

Emerging scientific evidence suggests that the supplementation of probiotics may help to reduce/manage blood cholesterol levels in humans. We evaluated the in vitro cholesterol-lowering activity of the probiotic strain Bacillus coagulans MTCC 5856. This probiotic de-conjugated bile salts and liberated deoxycholic acid, confirming its bile salt hydrolase activity. Furthermore, B. coagulans MTCC 5856 also significantly (P < 0.05) reduced cholesterol levels in culture media under growing (48.42%), resting (live but suspended in buffer, 36.47%) and even heat-killed (dead, 8.5%) conditions. Bacillus coagulans MTCC 5856 significantly reduced the cholesterol levels in cholesterol-rich foods, such as egg yolk (39.79%), chicken liver (45.44%) and butter (49.51%), when incubated for 24 h in conditions mimicking the in vivo environment. Bacillus coagulans MTCC 5856 also produced significant (P < 0.05) amounts of propionic acid and butyric acid while fermenting cholesterol-rich foods. The multitudinous ways by which B. coagulans MTCC 5856 reduces cholesterol levels endorses its application in functional food formulations and as a dietary ingredient for the management of hypercholesterolemia, potentially reducing the incidence of coronary heart disease and other related disabilities.