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. Trial Registration: Clinical Trials Registry India Identifier: CTRI/2015/05/005754

Bacillus coagulans MTCC 5856 has been marketed as a dietary ingredient, but its efficacy in diarrhea predominant irritable bowel syndrome (IBS) condition has not been clinically elucidated till date. Thus, a double blind placebo controlled multi-centered trial was planned to evaluate the safety and efficacy of B. coagulans MTCC 5856 in diarrhea predominant IBS patients. Thirty six newly diagnosed diarrhea predominant IBS patients were enrolled in three clinical centres. Along with standard care of treatment, 18 patients in group one received placebo while in group two 18 patients received B. coagulans MTCC 5856 tablet containing 2 × 109 cfu/day as active for 90 days. Clinical symptoms of IBS were considered as primary end point measures and were evaluated through questionnaires. The visual analog scale (VAS) was used for abdominal pain. Physician’s global assessment and IBS quality of life were considered as secondary efficacy measures and were monitored through questionnaires. Laboratory parameters, anthropometric and vital signs were within the normal clinical range during the 90 days of supplementation in placebo and B. coagulans MTCC 5856 group. There was a significant decrease in the clinical symptoms like bloating, vomiting, diarrhea, abdominal pain and stool frequency in a patient group receiving B. coagulans MTCC 5856 when compared to placebo group (p < 0.01). Similarly, disease severity also decreased and the quality of life increased in the patient group receiving B. coagulans MTCC 5856 when compared to placebo group. The study concluded that the B. coagulans MTCC 5856 at a dose of 2 × 109 cfu/day along with standard care of treatment was found to be safe and effective in diarrhea predominant IBS patients for 90 days of supplementation. Hence, B. coagulans MTCC 5856 could be a potential agent in the management of diarrhea predominant IBS patients.

In recent decades, probiotics have attracted widespread attention and their application in healthcare and animal husbandry has been promising. Among many probiotics, Bacillus coagulans (B. coagulans) has become a key player in the field of probiotics in recent years. It has been demonstrated to be involved in regulating the balance of the intestinal microbiota, promoting metabolism and utilization of nutrients, improving immunity, and more importantly, it also has good industrial properties such as high temperature resistance, acid resistance, bile resistance, and the like. This review highlights the effects of B. coagulans in animal husbandry and its underlying mechanisms.

Summary: The study was aimed to find out the stability of Bacillus coagulans MTCC 5856 in functional foods during processing and storage. B. coagulans MTCC 5856 was found to be stable during baking and storage at frozen conditions of banana muffins (92% viability) and waffles (86% viability) upto 12 months. After brewing coffee at 90 °C for 2 min, there was 87% viability and retained 66% viability even after maintaining temperature at 77 °C for 4.0 h. It showed over 95% viability in chocolate fudge frosting, hot fudge toppings, peanut butter, strawberry preserve and vegetable oil at room temperature upto 12 months. It was found to be stable in apple juice upto 6 months at refrigerated condition and concentrated glucose syrup at 4 ± 3 and 25 ± 2 °C upto 24 months. B. coagulans MTCC 5856 showed promising stability during processing and storage of functional foods and could be an excellent probiotic ingredient to use in various food applications.

Acne vulgaris is a common skin disorder of pilosebaceous units. The therapy for mild-to-moderate acne includes topical antibiotics, benzoyl peroxide and retinoids. In this open-label, randomized monocentric study, we compared the efficacy of LactoSporin^® 2% w/w cream with benzoyl peroxide in 64 male and female subjects with mild-to-moderate acne for three weeks. The efficacy parameters were evaluated based on the dermatologist visual assessment and instrumental measurements using Sebumeter^® MPA580, Antera 3D^TM and VISIA CR 2.2 and subject self-assessment questionnaires. Adverse events were recorded throughout the study period. In order to understand the mechanism of action and properties of LactoSporin, the pH stability, thermostability, antimicrobial activity and 5-alpha reductase activity were evaluated in vitro. A significant improvement was observed in the dermatological assessment of closed comedones (p < 0.0001), open comedones (p = 0.0069) and papules count (p < 0.0001) in comparison to the baseline in both LactoSporin and benzoyl peroxide groups. The antera analysis showed significant improvement in redness (p < 0.0001) and elevation (p < 0.0001) (small and medium) in both the treatment groups. The sebumeter analysis showed a significant decrease in sebaceous secretion (p < 0.0001) for LactoSporin, which resulted in reduced oiliness, pimples, acne spots and redness around the acne spot. The product was found to be safe without any irritancy. LactoSporin was stable at an acidic pH and temperature range of 70 to 90 °C, with antimicrobial activity against various pathogenic bacteria, including Cutibacterium acnes. It was also a potent inhibitor of 5-alpha reductase activity. Thus, it can be concluded that the efficacy of LactoSporin is equivalent to benzoyl peroxide in the treatment of mild-to-moderate acne lesions and better than benzoyl peroxide for reducing the sebaceous secretion and oily, greasy nature of the skin, implying its efficacy in other sebohorriec conditions.