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.

This study was conducted to evaluate the anti-diarrhoeal activity of Bacillus clausii strain UBBC 07 in patients suffering from acute diarrhoea. A total of 27 patients (average age of 35.44±8.08 years) with acute diarrhoea were included in a prospective, Phase II clinical study after informed consent and ethical committee approval. The criteria included for all subjects were ≥3 loose stool motions within 24 hours and for more than 7 days. All patients were assigned to receive one capsule of B. clausii strain UBBC-07 (containing 2×109 cfu) two times a day for a period of 10 days. Efficacy assessment of duration of diarrhoea, frequency of defecation, abdominal pain and stool consistency were tested on days 1, 3, 6 and 10. Safety was evaluated by assessing the incidence and type of adverse effects such as increase in blood pressure and pulse rate, physical examination and clinical laboratory tests, i.e. complete blood count, serum glutamic pyruvic transaminase, serum creatinine, and stool examination and microscopy, on day 1 and day 10. The results of this study clearly showed that the mean duration of diarrhoea decreased from 34.81±4.69 to 9.26±3.05 (P<0.0001) min per day, the frequency of defecation also decreased from 6.96±1.05 to 1.78±0.50 (P<0.0001) times per day, abdominal pain decreased from 3.22±0.93 (severe) to 0.74±0.71 (absent) (P<0.0001), and stool consistency improved from 3.93±0.38 (watery) to 1.22±0.42 (soft) (P<0.0001). No significant change in safety parameters were observed during treatment. This study shows that the B. clausii strain UBBC-07 can potentially be effective in alleviating the symptoms of diarrhoea without causing any adverse effects.

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.

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.

Acute diarrhoea is one of the leading causes of mortality in infants and young children. Evidence suggests that probiotics can reduce diarrhoea duration. As the effects of probiotics are strain specific, the effect of Bacillus clausii UBBC-07, a safe probiotic strain in the treatment of acute diarrhoea in children was studied. The double blind, randomised, placebo-controlled, parallel group multicentric study was conducted at two outpatient facility sites in Lucknow, India. Children aged six months to five years suffering from acute diarrhoea, were randomly assigned to receive either probiotic (B. clausii UBBC-07) spore suspension or placebo suspension twice daily apart from oral rehydration solution (ORS). The duration of treatment was for five days with a follow -up until the 10th day. Outcomes evaluated were duration and frequency of diarrhoea, consistency of stool, fever and vomiting. The duration of diarrhoea was significantly shorter (P<0.05) in patients who received B. clausii suspension (75.66±13.23 h) than in placebo treated group (81.6±15.43 h). The average daily number of stools (frequency) was 8.67±3.42 at baseline in treatment group receiving B. clausii and 8.53±3.19 in placebo group. By day 4, there was a significant reduction (P<0.01) in frequency of stools in probiotic treated group (3.46±0.66) as compared to placebo group (4.57±1.59). Improvement in stool consistency was also observed in the probiotic treated group as compared to the placebo group. There was no effect on vomiting and duration of fever. B. clausii UBBC-07 significantly decreased the duration and frequency of diarrhoea as compared to placebo indicating effectiveness of strain in the treatment of acute diarrhoea in children and could be a safe alternative to antibiotics.