Role of a probiotic strain in the modulation of gut microbiota and cytokines in inflammatory bowel disease.

OBJECTIVE: To assess the effect of a probiotic strain Bacillus clausii UBBC-07 on gut microbiota and cytokines in IBD patients. METHOD: Patients were randomly allocated to either placebo or probiotic Bacillus clausii UBBC-07 for four weeks along with the standard medical treatment (SMT). Enrolled patients were evaluated before and after intervention for presence of the given probiotic, change in gut microbiota, change in serum cytokines, serotonin and dopamine, symptoms of disease, physical, behavioral and psychological parameters. RESULTS: Probiotic strain Bacillus clausii UBBC-07 showed good survival in IBD patients in the treatment group (p < 0.01) without any reported adverse event. Metagenomic analysis showed that the given probiotic strain was able to modulate the gut microbiota in treated group. Phylum Firmicutes was increased and phylum Bacteroidetes was decreased in the probiotic treated group. A significant increase was observed in the abundance of anaerobic bacterial genera Lactobacillus, Bifidobacterium and Faecalibacterium in the probiotic treated group (p < 0.01) as compared to placebo group. Significant increase was observed in IL-10 (p < 0.05) and variable decrease in the secretion of IL-1ß, TNF- α, IL-6, IL -17 and IL -23 in probiotic treated group. In the treatment group a significant decrease in the symptoms of IBD and improvement in the psychological parameter to various degrees was noted. CONCLUSION: These results indicated that probiotic strain B clausii UBBC-07 affected the gut microbiota and cytokine secretion and shown efficacy in IBD patients.

The effect of Bacillus coagulans Unique IS-2 supplementation on plasma amino acid levels and muscle strength in resistance trained males consuming whey protein: a double-blind, placebo-controlled study.

PURPOSE: The aim of the present study was to assess the effect of Bacillus coagulans Unique IS-2 supplementation on absorption and utilization of protein in resistance-trained males. METHODS: In this double blind, placebo-control trial, resistance-trained males (21.08 ± 2.84 years) were randomized to consume, either 20 g of whey protein powder {80% whey protein concentrate (WPC80), amounting to 15.4 g protein} with 2 billion CFU Bacillus coagulans Unique IS-2 (supplemental group) or 20 g of whey protein powder and lactose instead of Bacillus coagulans (placebo group) once daily for 60 days with a controlled resistance exercise protocol. The whey protein concentrate (WPC-80) given to both groups had a lactose content of 6.8%. Plasma-free amino acids (PFAAs) were determined at baseline, at 30 and 60 days of supplementation. Muscle strength, hypertrophy, VO2 max, and body composition, and other biochemical parameters were assessed at baseline and end line. RESULTS: A positive effect of probiotic Bacillus coagulans Unique IS-2 supplementation was observed on protein absorption as evidenced by an increase in total PFAA by + 16.1% (p = 0.004). Branched chain amino acids (BCAA) comprising isoleucine (p = 0.016), leucine (p = 0.001), and valine (p = 0.002) were increased by + 33.1% in ITT analysis as compared to placebo after 60 days. At 30 days an increase in isoleucine by + 35% (p = 0.113), leucine by + 43% (p = 0.032), and valine by + 32% (p = 0.017) was observed in ITT analysis. Probiotic effect was shown on exercise performance as evidenced by an increase in one RM of leg press and vertical jump power by + 16.61% (p = 0.024) and + 7.86% (p = 0.007), respectively. CONCLUSION: Significantly increased absorption of BCAA with supplementation of B. coagulans Unique IS-2 along with whey protein and improvement in leg press and vertical jump power was noted indicating the positive effect of the probiotic on muscle power in the lower body. TRIAL REGISTRATION NUMBER: CTRI/2017/03/008117; Date:16.03.2017.

Self-preserving gelatin emulgel containing whole cell probiotic for topical use: preclinical safety, efficacy, and germination studies.

BACKGROUND: Dermal disorders, owing to disruption of skin-microflora balance can be served by direct application of probiotics. However, there are few topical whole probiotic products in market because of (i) loss of viability during manufacturing and storage(ii) inadequate germination and retention on skin. Presently we report a novel (IPA 201811010395) emulgel incorporatingBacillus coagulans (Unique IS-2) for possible topical use. METHODS: Developed emulgel was characterized for particle size, texture, rheology, morphology, water activity, self-preservation, safety, and stability. RESULTS: We successfully incorporated 97 ± 5% (1.7×108CFU/g) Bacillus coagulans in honeycomb network of gelatin nanoparticles (≈600 nm). Maintenance of CFU at 30 ± 2°C, 65 ± 5% RH for 3 months confirmed viability of incorporated probiotic. Low water-activity (0.66-0.732aw) and challenge test (0.05-0.5% viability) confirmed its self-preserving nature. Early initiation (6 h) and complete (24 h) spore germination was evident onrabbit skin. No cytotoxicity, dermal irritation or translocation established its safety. Faster wound closure and reduced oxidative stress (LPO, catalase, SOD, glutathione reductase) in comparison to Soframycin® (1%w/w Framycetin) was observed in excision wound in mice. CONCLUSIONS: A whole cell probiotic formulation that is self-preserving, maintains probiotic viability, guarantees germination, and has wound healing properties was successfully formulated.

Effect of Multi-strain Probiotic Formulation on Students Facing Examination Stress: a Double-Blind, Placebo-Controlled Study.

In this placebo-controlled, double-blind clinical trial, we have investigated the effect of multi-strain probiotic (Bacillus coagulans Unique IS2, Lactobacillus rhamnosus UBLR58, Bifidobacterium lactis UBBLa70, Lactobacillus plantarum UBLP40 (each of 2 billion CFU); Bifidobacterium breve UBBr01, Bifidobacterium infantis UBBI01 (each of 1 billion CFU)) capsule with glutamine (250 mg) on students facing examination stress. A total of 80 students (18-24 years) were enrolled and randomised to receive multi-strain probiotic or placebo capsules twice a day for 28 days (i.e. pre- and during examination). The stress was analysed at the baseline and the end of the treatment by using the perceived stress scale (PSS), depression anxiety stress scale (DASS), and state-trait anxiety inventory (STAI) questionnaire. The serum cortisol levels were also determined. As a result, at the end of the trial, a total of 74 students completed the study, and those who consumed probiotic capsules showed a significant reduction in PSS, DASS, and STAI scores, and serum cortisol levels from the baseline as compared with placebo. No adverse events were reported during the study. In conclusion, the multi-strain probiotic is effective in reducing stress associated with examination. CTRI/2019/03/018178.

Evaluation of the Effect of Probiotic Bacillus coagulans Unique IS2 on Mutans Streptococci and Lactobacilli Levels in Saliva and Plaque: A Double-Blind, Randomized, Placebo-Controlled Study in Children.

BACKGROUND: Probiotic organisms are known to reduce caries causing microorganisms mutans streptococci and lactobacilli. Aim of the Study. To evaluate the effect of probiotic Bacillus coagulans Unique IS2 on mutans streptococci and lactobacilli levels in saliva and plaque in children. INTRODUCTION: Dental caries or tooth decay is because of the demineralization of the tooth enamel leading to the breakdown of the enamel causing cavities to be formed. Demineralization of the tooth happens because of the acid secreted by bacteria like mutans streptococci and lactobacilli. It is now suggested that probiotic usage prevents the overgrowth of these pathogenic microbes, thereby reducing caries activity. Methodology. In this double-blind, randomized, placebo-controlled study, 48 children with ages ranging from 5 to 15 years were divided into two groups, the probiotic and placebo groups. Chewable tablets with and without probiotic Bacillus coagulans Unique IS2 were administered for two weeks. Stimulated saliva samples and plaque were collected at baseline and at the end of 14 days to measure the pH, mutans streptococci, and lactobacilli count of saliva and plaque using chairside kits. RESULTS: A statistically significant reduction in mutans streptococci and lactobacilli counts of both saliva and plaque samples was observed in the B. coagulans Unique IS2 treated group after 14 days of administration compared to the baseline and placebo group (using paired t-test). CONCLUSION: Probiotic Bacillus coagulans Unique IS2 (2 billion cfu) chewable tablet is effective in reduction and inhibition of caries causing mutans streptococci and lactobacilli levels in saliva and plaque in children.

Bacillus coagulans Unique IS2 in Constipation: A Double-Blind, Placebo-Controlled Study.

Functional constipation has a high prevalence in both adults and children affecting quality of life. Evidence suggests that probiotics can reduce the symptoms of constipation. As the effects of probiotics are strain specific, the efficacy of Bacillus coagulans Unique IS2 in the treatment of functional constipation in adults was evaluated. Subjects (n = 100) diagnosed with functional constipation were supplemented with either B. coagulans Unique IS2 (2 billion CFU) or placebo capsules once daily for 4 weeks. Subjects were evaluated for treatment success (defined as three or more spontaneous stools per week), stool consistency, difficulty of defecation, defecation and abdominal pain. By the end of the fourth week, there was a statistically significant (p < 0.001) increase in number of bowel movements in the probiotic treated group as compared to placebo. Ninety eight percent of subjects in the probiotic group achieved normal stool consistency as compared to placebo (74%). Moreover, there was relief from symptoms of incomplete evacuation, painful defecation and abdominal pain associated with constipation in probiotic treated group as compared to placebo. In conclusion, B. coagulans Unique IS2 significantly decreased the symptoms of constipation indicating effectiveness of the strain in the treatment of constipation.Trial registration: CTRI/2017/11/010539.

Efficacy of UB0316, a multi-strain probiotic formulation in patients with type 2 diabetes mellitus: A double blind, randomized, placebo controlled study.

BACKGROUND: Role of multi-strain probiotic formulations in the management of type 2 diabetes mellitus (T2DM) has rarely been reported. In the present study, the effects of the probiotic formulation, UB0316 (L. salivarius UBLS22, L. casei UBLC42, L. plantarum UBLP40, L. acidophilus UBLA34, B. breve UBBr01, B. coagulans Unique IS2, 5 billion CFU each and fructo-oligosaccharides, 100 mg) in patients with T2DM were assessed. METHODS: A total of 79 eligible subjects (18-65 years, on stable metformin therapy) were randomly assigned to receive UB0316 or placebo, twice-a-day for 12 weeks. The primary endpoint was change in glycated hemoglobin (HbA1c), secondary were assessment of blood glucose levels, HOMA-IR (homeostatic model assessment of insulin resistance), insulin, body weight, and blood lipids. Quality of life, vital signs, physical investigations, safety and Physician/Subject's Global assessment were also evaluated. RESULTS: Twelve week multi-strain probiotic (UB0316) supplementation significantly reduced HbA1c (7.70 ± 0.79%; p = 0.0023) and weight (67.00 ± 8.82 kg; p < 0.001) as compared to placebo (HbA1c: 8.30 ± 1.35%; weight: 67.60 ± 9.46 kg). The changes recorded in fasting blood glucose (FBG), HOMA-IR, insulin, TC, TG, HDL, and LDL levels were however not significantly altered as compared to placebo. No severe adverse events, abnormal vital and physical signs were reported. The quality of life of T2DM was significantly improved. CONCLUSIONS: UB0316 significantly improved glycemic control as indicated by the decrease in HbA1c levels. There was also a significant decrease in weight in the probiotic treated subjects as compared to placebo.

Randomized clinical trial: the effect of probiotic Bacillus coagulans Unique IS2 vs. placebo on the symptoms management of irritable bowel syndrome in adults.

The therapeutic effects of B. coagulans Unique IS2 have been well established in children with irritable bowel syndrome (IBS), but its efficacy in adults remain under reported. Thus, in this study the efficacy of B. coagulans Unique IS2 in the management of IBS symptoms in adults was investigated. Patients (n = 153) fulfilling Rome III criteria were provided placebo capsules for a 2 weeks run-in period. Only patients satisfying compliance criteria (n = 136) were randomized (double blind) to receive either B. coagulans Unique IS2 (2 billion CFU) or placebo capsules daily for 8 weeks. Reduction of abdominal discomfort/pain intensity and increase in complete spontaneous bowel movements were analyzed as primary end points. Other clinical symptoms of IBS and serum cytokines were also evaluated. B. coagulans Unique IS2 showed significant improvement in primary and secondary endpoints, as compared to placebo. Haematology of both the arms remained normal. No significant changes in pro- (IL-6, IL-12, TNF-α, INF- γ) and anti-inflammatory cytokine (IL-10) levels were detected at the end of B. coagulans treatment (8 weeks) as compared to placebo. B. coagulans was well tolerated with no severe adverse events to report. Overall, the results demonstrate that B. coagulans Unique IS2 is efficacious in the management of IBS symptoms in adults (18-60 years).