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. 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. 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. 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.

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).

The efficacy of the probiotic strain, Bacillus coagulans Unique IS2 in the treatment of Irritable Bowel Syndrome (IBS) was evaluated in children. A total of 141 children of either sex in the age group 4-12 years, diagnosed with IBS according to the Rome III criteria, participated in the double-blind randomised controlled trial. Children received either B. coagulans Unique IS2 chewable tablets or placebo once daily for eight weeks followed by a two week follow-up period. Reduction in pain intensity as well as other symptoms associated with Irritable Bowel Syndrome like abdominal discomfort, bloating, distension, sense of incomplete evacuation, straining at stool, urgency of bowel movement, passage of gas and mucus, and bowel habit satisfaction were assessed. B. coagulans Unique IS2 treated group showed a greater reduction in pain scores as evaluated by a weekly pain intensity scale. There was a significant reduction (P<0.0001) in pain intensity in the probiotic treated group (7.6±0.98) as compared to the placebo group (4.2±1.41) by the end of the treatment period (8 weeks). There was also a significant improvement in stool consistency as well as reduction in abdominal discomfort, bloating, staining, urgency, incomplete evacuation and passage of gas. Bowel habit satisfaction and global assessment of relief was also observed in the B. coagulans Unique IS2 treated group as compared to the placebo group. This study demonstrates the efficacy of B. coagulans Unique IS2 in reducing the symptoms of Irritable Bowel Syndrome in children in the age group of 4-12 years.

Probiotics are vital bacteria that colonize the intestine and modify its microflora with benefits for the host. Very few members of the Bacillus group are recognized as safe for use and hence only a few strains are available as commercial preparations for application in humans and animals. Acute and subacute studies in rats were conducted to establish safety of Bacillus clausii (B. clausii) UBBC07. In the acute toxicity study, the oral LD50 for B. clausii UBBC07 was found to be >5000 mg/kg (630 billion cfu/kg) body weight. The NOAEL for B. clausii UBBC07 was found to be 1000 (126 billion cfu) mg/kg body weight/day by oral route in the subacute toxicity study. There were no significant differences between control and treated groups in any of the endpoints assessed using an OECD443 or OECD407 protocol. B. clausii UBBC07 was found to be resistant to three antibiotics -clindamycin, erythromycin and chloramphenicol. Analysis of the whole genome sequence of B. clausii UBBC07 revealed that the antibiotic resistance genes are present in chromosomal DNA which is intrinsic and not transferable. Toxin genes were also found to be absent. These results suggest consumption of B. clausii UBBC07 is safe for humans.

This clinical trial was carried out to assess the effects of multi-strain probiotic capsule (UB0316: Lactobacillus salivarius UBLS-22, Lactobacillus casei UBLC-42, Lactobacillus plantarum, UBLP-40, Lactobacillus acidophilus UBLA-34, Bifidobacterium breve UBBr-01, Bacillus coagulans Unique IS2 5×10⁹ cfu each and fructo-oligosaccharide, 100 mg) on overweight/obesity-related parameters. Ninety subjects (age, 30-65 years; body mass index (BMI), 25-32 kg/m²) were randomised into two groups, i.e. UB0316 (probiotic) and placebo (excipient maltodextrin). They were instructed to take 2 capsules (UB0316 or placebo) per day after meals for 12 weeks. Primary (BMI), and secondary (waist-to-hip ratio: WHR; body weight, body fat; sugar and lipid profile) endpoint measures were evaluated at scheduled visits. Vital signs, physical investigations, quality of life, physician/subjects global assessment and adverse events were also recorded. A total of 71 subjects completed the scheduled study visits and analysis thereof showed that a 12-week UB0316 supplementation significantly reduced BMI (95% CI: -0.64, -0.27; P=0.0001), body weight (95% CI: -1.16, -0.50; P<0.0001), and WHR (95% CI: -0.06, -0.01; P=0.007) from the baseline, compared to placebo. Fat, blood lipid and sugar profile changes were non-significant. UB0316 significantly improved quality of life of overweight/obese individuals. Furthermore, no severe adverse events or abnormal findings were noted during vital, blood and physical examinations. In conclusion, this 12-week trial demonstrates that UB0316 is effective in reducing BMI, body weight and WHR in overweight/obese adults.