Bacillus coagulans Unique IS2

Behavior of Bacillus coagulans Unique IS2 spores during passage through the simulator of human intestinal microbial ecosystem (SHIME) model

LWT - Food Science and Technology 124 (2020) 109196
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Survival and germination of spores in upper gastro intestinal tract (GIT) is crucial for spore-probiotics to confer beneficial effects to the host. In the present study, the survival, germination and metabolic activity of Bacillus coagulans Unique IS2 spores in an in vitro Simulator of Human Intestinal Microbial Ecosystem (SHIME®) model was investigated. The survival and germination of spores under fed and fasted GIT conditions was analyzed by using flow cytometry and agar plate method. Lactate and short chain fatty acid (SCFA) were measured as indicators of metabolic activity. B. coagulans Unique IS2 showed 102% and 99% survival under fed and fasted conditions of upper GIT. Significant amount of spore germination was detected in small intestine, where the spores had not transformed completely into vegetative cells but assisted in digestion of lactose and fructose. Furthermore, once the germinated spores entered into the colon they underwent vegetative growth and produced significant levels of lactate (8.30 ± 0.07 mM) and acetate (31.75 ± 3.58 mM) as major metabolites. In conclusion, B. coagulans Unique IS2 demonstrated ability to survive and germinate under gastrointestinal conditions and aid in digestion of carbohydrates

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

Scientific Reports. 2019 Aug 21; 9(1):1-9
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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).

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

Probiotics and Antimicrobial Proteins. 2019 Mar 25:1-8
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 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.

Application of spore-forming probiotic Bacillus in the production of Nabat - A new functional sweetener

LWT – Food Science and Technology 113 (2019): 108277
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The basis of the present study was developing a novel type of functional sweet product with the additive probiotic spore forming bacteria that do not require cold chain or any specific storage condition. In this study, rock candy containing probiotic bacteria was produced in dry ambient condition. Spore-forming bacilli were selected as probiotics that are resistant to thermal processes and osmotic conditions. Rock candies were coated with an edible coating containing carboxymethyl cellulose, sucrose, glucose syrup, fructose syrup and a probiotic strain. After coating process, the parameters of turbidity (created by water dissolution of coated Nabat); effect of drying temperature on bacterial viability; moisture content, water activity, ash content of product; as well as product storage time were evaluated. Under thermal stress during both dissolution in hot liquid and drying, the survivability of the spores used in the coated rock candies did not fall significantly. Viability evaluation of the probiotic bacilli in the product after six months of storage at ambient temperature revealed 90.39 and 89.07% viability of Bacillus coagulans and Bacillus subtilis spores, respectively. Our results showed that spore-forming probiotics embedded in rock candy are highly stable during storage at ambient temperature and dry condition.

Efficacy of Bacillus coagulans Unique IS2 in treatment of irritable bowel syndrome in children: a double blind, randomised placebo controlled study

Benef Microbes. 2018 Jun 15; 9(4):563-572.
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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.

Antiproliferative Effects of Bacillus coagulans Unique IS2 in Colon Cancer Cells

Nutrition and Cancer. 2017 Oct 3; 69(7):1062-8
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In the present study, the in vitro anticancer (antiproliferative) effects of Bacillus coagulans Unique IS2 were evaluated on human colon cancer (COLO 205), cervical cancer (HeLa), and chronic myeloid leukemia (K562) cell lines with a human embryonic kidney cell line (HEK 293T) as noncancerous control cells. The Cytotoxicity assay (MTT) clearly demonstrated a 22%, 31.7%, and 19.5% decrease in cell proliferation of COLO 205, HeLa, and K562 cells, respectively, when compared to the noncancerous HEK 293T cells. Normal phase-contrast microscopic images clearly suggested that the mechanism of cell death is by apoptosis. To further confirm the induction of apoptosis by Unique IS2, the sub-G0–G1 peak of the cell cycle was quantified using a flow cytometer and the data indicated 40% of the apoptotic cells in Unique IS2-treated COLO cells when compared with their untreated control cells. The Western blot analysis showed an increase in pro-apoptotic protein BAX, decrease in antiapoptotic protein, Bcl2, decrease in mitochondrial membrane potential, increase in cytochrome c release, increase in Caspase 3 activity, and cleavage of poly(ADP-ribose) polymerase. The present study suggests that the heat-killed culture supernatant of B. coagulans can be more effective in inducing apoptosis of colon cancer cells and that can be considered for adjuvant therapy in the treatment of colon carcinoma.

Clinical effect of pro-biotic containing Bacillus coagulans on plaque-induced gingivitis: A randomized clinical pilot study

Journal of Health Science. 2017 Sep 1; 7(3):7-12
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To evaluate the clinical effect of Bacillus coagulans on plaque-induced gingivitis.Thirty subjects with plaque induced were enrolled in the study. At baseline, Gingivial index (GI) and plaque index (PI) were assessed. Saliva samples were collected for glutathione peroxidase (GPx) activity analysis and to determine load of lactobacilli. Subsequenlty participants were randomly provided with chewable tablets to be consumed 3 × daily for 3 month containing 100 million colony forming units (CFU)/ tablet of B.coagulans or without B.coagulans (placebo). After 3 months, recording of GI, PI and saliva sampling were repeated. At baseline, mean GI, and mean PI did not differ significantly between both groups. At re-evaluation, mean GI, and bleeding on probing of the probiotic group were both significantly (p<0.0001) lower than in the placebo group. Mean PI level did not differ significantly between the groups. In the probiotic group, mean glutathione peroxidase activity (GPx) was significantly (p<0.02) lower than in the placebo group at re-evaluation. The consumption of probiotic containing Bacillus coagulans seems to modulate inflammatory response in plaque induced gingivitis.

Draft Genome Sequence of the Spore-Forming Probiotic Strain Bacillus coagulans Unique IS-2

Genome Announc. 4.2 (2016): e00225-16
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Bacillus coagulans Unique IS-2 is a potential spore-forming probiotic that is commercially available on the market. The draft genome sequence presented here provides deep insight into the beneficial features of this strain for its safe use as a probiotic for various human and animal health applications.

Comparison of the Effects of pH-Dependent Peppermint Oil and Synbiotic Lactol (Bacillus coagulans + Fructooligosaccharides) on Childhood Functional Abdominal Pain: A Randomized Placebo-Controlled Study

Iranian Red Crescent Medical Journal. 2015 Apr; 17(4)
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We evaluated the effectiveness of a synbiotic in the treatment of childhood functional abdominal pain (FAP). Probiotics are effective in the treatment of functional gastrointestinal disorders in adult patients, but there is lack of information in children. Children with FAP, based on the Rome III criteria (n = 115, aged 6-18 years), were randomized to receive either synbiotic (Bacillus coagulans, Unique IS-2, 150 million spore plus FOS, 100 mg) twice daily or placebo for four weeks. Treatment response was defined as ≥ 2-point reduction in the 6-point self-rated pain scale or “no pain”. Physician-rated global severity and improvement were also evaluated. Patients were followed for a total of 12 weeks. Eighty-eight patients completed the trial (45 with synbiotic). Response rate was higher with synbiotic than placebo after medication (60% vs. 39.5%, P = 0.044), but was not different between the two groups at week 12 (64.4% vs. 53.4%, P = 0.204). Difference between the two groups regarding the physician-rated global severity over the study period was not statistically significant (z = -1.87, P = 0.062). There was no significant difference between the two groups in physician-rated global improvement (week 4, P = 0.437; week 12, P = 0.111). Receiving synbiotic (OR 2.608, 95% CI: 1.01-6.68) and baseline pain score (OR 2.21, 95% CI: 1.19-4.10) were predictors of treatment response after medication. The synbiotic containing Bacillus coagulans and FOS seems to be effective in the treatment of childhood FAP. Further trials are recommended in this regard.

Anti-Inflammatory And Immunomodulatory Effects Of Bacillus Coagulans Unique IS2

International Journal of Probiotics & Prebiotics. 2015 Feb 1; 10(1):31
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The anti-inflammatory and immunomodulatory effects of the heat-killed filtered culture supernatant (HSUP) of Bacillus coagulans Unique IS2 (BC IS2) strain was investigated. The anti-inflammatory effects BC IS2 was studied using lipolysaccharide (LPS)-induced inflammation of mouse macrophage cells, RAW 264.7 cells, and determining the protein and RNA levels of cyclooxygenase-2 (COX-2) by immunoblot and RT-PCR respectively. The immunomodulatory effects were studied using LPS-activated PBMCs by quantifying the cytokines produced by Th1 cells (TNF-α, IFN-g, IL-2) and Th2 cells (IL6, IL-10). Results of the study show that the anti-inflammatory effects of the heat killed filtered culture supernatant of Bacillus coagulans Unique IS2 (HUSP BC IS2) were mediated through inhibition of COX-2 and inflammatory cytokines via inhibition of NF-kB activity. The immunomodulatory effects were mediated by significant production of Th1 cytokines. Our data suggests that a heat stable component of the supernatant of Bacillus coagulans Unique IS2 was able to reduce inflammation through modulation of the inflammatory gene expressions of COX-2, NF-kB , via cytokines initiating a cellular immune response. The study provides evidence that the heat killed supernatant of Bacillus coagulans Unique IS2 acts as an adjuvant for inflammatory diseases, mechanism of which is through Th1 cellmediated immune response.

Evaluation of anti-inflammatory activity of probiotic on carrageenan-induced paw edema in Wistar rats

International Journal of Biological Macromolecules. 2015 Jan 1; 72:1277-82
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Probiotic strain Lactobacillus sporogenes and Bifidobacteria bifidum were used to assess the anti-inflammatory properties in Carrageenan induced acute inflammatory model. Non-encapsulated and encapsulated Probiotic strain of Bifidobacteria bifidum and Lactobacillus sporogenes was given orally. Diclofenac sodium was used as standard drug at a concentration of 150 mg/kg of body weight. Edema was induced with 1% carrageenan to all the groups except group A after half an hour of the oral treatments. Paw thickness was checked at t = 1, 2, 4 and 24 h. Stair climbing score and motility score were assessed at t = 24 h. Non-encapsulated and encapsulated Probiotic Bifidobacteria and Lactobacillus showed a statis- tically significant decrease in paw thickness at P < 0.05. The percentage inhibition in paw thickness of non-encapsulated and encapsulated probiotic L. sporogenes and B. bifidum is 37 ± 3% and 43 ± 2% after 24 h of treatment. They both significantly increased stair climbing and motility score. Probiotic B. bifidum and L. sporogenes significantly decreased the inflammatory reactions induced by carrageenan.

Evaluating the efficacy of probiotic on treatment in patients with small intestinal bacterial overgrowth (SIBO) - A pilot study

The Indian Journal of Medical Research. 2014 Nov; 140(5):604
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In the healthy human being, there are a variety of intrinsic defense mechanisms that control the number of bacteria and its composition in various parts of the gastrointestinal tract. These defense mechanism include gastric acid secretion, preserved gastrointestinal motility (particularly phase III of the migrating motor complex), normal bacterial microflora, pancreatic biliary secretion, and an intact ileocecal valve, all of which protect against bacterial overgrowth. Any disturbance or alteration in the inherent defense mechanisms can lead to small intestinal bacterial overgrowth (SIBO); therefore, we can define SIBO as an increase in the number and/or an alteration in the type of bacteria found in the small bowel. The etiology of SIBO is presumably multiefactorial and complex, including alternation of gastric acid secretion (primarily in the form of achlorhydria and pancreatic and biliary secretions insufficiency), chronic disease (e.g.renal failure, liver cirrhosis) and old age are among some of the different causes that result in competition between the host and overgrown bacteria for the ingested nutrients and catabolism of these nutrients which subsequently lead to release of toxic metabolites causing variable degree of injury to the proximal intestinal cells. The clinical features of SIBO are widely variable, including abdominal bloating, nausea, abdominal pain, chronic diarrhea, flatulence and weight loss; however, some patients have only subtle symptoms. For this reason, the diagnosis may often be overlooked. Although the diagnosis of SIBO is complex;, there are a few different approaches that may be used to help establish the diagnosis in patients with suspected SIBO. The gold standard for diagnosis remains microbial investigation of jejunal aspirate. Non-invasive, indirect methods include hydrogen and methane breath testing (using either glucose or lactulose as a substrate). A third approach is the empiric treatment in patients with suspected SIBO with a trial of antibiotics with subsequent evaluation of symptomatic response and normalization of breath testing. The underlying principles of treatment of SIBO are complex and typically treated with a course of antibiotics as first line therapy along with addressing the underlying defect. Additionally, probiotics, herbals, and certain diets may also play a significant role in the treatment of SIBO in the future.

Clinical Study of Bacillus coagulans Unique IS-2 (ATCC PTA-11748) in the Treatment of Patients with Bacterial Vaginosis

Indian Journal of Microbiology. 2012 Sep; 52(3):396–399
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Bacterial vaginosis (BV) is the most prevalent vaginal infection worldwide and is characterized by reduction of native lactobacilli. Antimicrobial therapy used to cure the disease is often found to be ineffective. We postulate that Bacillus coagulans Unique IS-2 (Unique Biotech Limited, India) might provide an appendage to antimicrobial treatment and improve curing rate. In the present study 40 Indian women diagnosed with BV by the presence of symptoms including white discharge, Ph greater than 4.7, burning micturation, itching, soreness and redness at vulva. The subjects were divided in 2 groups probiotic (n = 20) and control (n = 20) based on age (control group, 33 ± 3 years and probiotic group, 32.5 ± 3 years), history of previous vaginosis (control group, 75% or 15/20 and probiotic group, 75% or 15/20) and severity of current vaginosis infection (burning micturition and itching, 35% in each group). Probiotic group subjects were assigned to receive a dose of antibiotic therapy [Ofloxacin–Ornidazole with strength of 200–500 mg per capsule/day for 5 days along with vaginal peccaries (co-kimaxazol) for 3 days] simultaneously with two probiotic capsules (109 CFUs of Bacillus coagulans Unique IS-2 per capsule). The control group received only antibiotic therapy. At the end of the treatment the 80% of probiotic group subjects showed significant positive response as revealed by reduction of vaginosis symptoms compared to the control group which exhibited reduction in 45% subjects only. Thus, the results of present study indicate that strain Bacillus coagulans Unique IS-2 can provide benefits to women being treated with antibiotics to cure an infectious condition.

Study of Effects of Probiotic Lactobacilli in Preventing Major Complications in Patients of Liver Cirrhosis

Intl J Biomed Pharma Sci. 2012; 3(1):206-11
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The aim was to evaluate the effects of probiotic lactobacilli on incidence of major complications, hospital admissions and mortality in patients of liver cirrhosis. In this randomized, double-blind, placebo-controlled study, 65 patients with liver cirrhosis received either lactobacilli (n = 34) or placebo (n =31) for 6 months. They were monitored for complications (hepatic encephalopathy, variceal bleeding, and spontaneous bacterial peritonitis), hospital admissions and deaths, if any. Serum bilirubin, SGPT, SGOT, serum proteins, blood urea, Sr.creatinine and plasma-ammonia were done at each visits. Probiotic lactobacilli significantly reduced the incidence of hepatic encephalopathy and hospital admissions. There was significant decrease in plasma-ammonia in lactobacilli treated group. Though the serum bilirubin levels worsened in both the groups, this worsening was significantly less in the lactobacilli treated group as against placebo. The present study suggests that the use of probiotic lactobacilli is beneficial in prevention of major complications in patients with liver cirrhosis.

Efficacy of bacillus coagulans strain Unique IS-2 in the treatment of patients with acute diarrhea

International Journal of Probiotics & Prebiotics. 2012 Feb 1; 7(1)
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The objective of this study was to evaluate the efficacy and safety of Bacillus coagulans strain Unique IS-2 in the treatment of patients with acute diarrhea. To this end, a total of 28 patients with acute diarrhea were included in a prospective, phase II clinical study upon obtaining consent and ethical committee approval. The trial was performed on patients of both sexes between 18 to 55 years of age and having e”3 loose motions in last 24 hours for less than7 Days. All patients were assigned to receive capsule (containing 2 billion CFU of Bacillus coagulans strain Unique IS-2) two times a duration of 10 days. Efficacy was evaluated by assessment of duration of diarrhea (in minutes) and frequency of defecation (times per day), abdominal pain (3=severe; 2=moderate; 1=mild; 0=absent) and consistency of stool (1=normal, 2=hard, 3= semi liquid, and 4=loose). Safety aspects of capsule were evaluated by assessment of incidence, type of adverse events, physical examination, and clinical laboratory test values (CBC, SGPT, serum creatinine, stool routine and microscopy). Concomitant medications including rescue medications were monitored throughout the study. Efficacy assessment for duration of diarrhea, frequency of defecation, abdominal pain, consistency of stool and fever was done on 1, 3, 6 and 10 days. Mean values for, duration of diarrhea decreased from 35.60 ± 5.46 to 3.52 ± 2.69 min per day, frequency of defecation was decreased from 7.96 ± 3.89 to 0.76 ± 0.60 times per day, abdominal pain decreased from 3.16 ± 0.99 to 0.36 ± 0.49 and consistency of stool improved from 3.84 ± 0.55 to 1.00 ± 0.00. No significant change in safety parameters was observed during treatment. This trial demonstrates that utilization of B. coagulans Unique IS-2 strain is efficient and safe to treat the patients with acute diarrhea.

Safety studies of Bacillus coagulans Unique is-2 in rats: morphological, biochemical and clinical evaluations

International Journal of Probiotics and Prebiotics Vol. 6, No. 1, pp. 43-48, 2011
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Probiotics are vital bacteria that colonize the intestine and modify its microbial flora with benefits for the host. Food products containing lactic acid bacteria have been available in the market including health supplements. However, there is not much information available regarding the toxicity of probiotic bacteria present in such preparations. In the present study acute and sub-acute oral toxicity of a new probiotic strain, Bacillus coagulans Unique IS-2 (MTCC- 5260) was conducted in Sprague Dawley rats. The rats were orally fed with a single dose of 3250 and 6500 mg/kg b.w/day (5×109 spores/g in water) dose of test organism for acute and sub-acute toxicity studies respectively. While the experimental rats received doses of 130, 650, 1300 mg/kg b.w/day (5×109 spores/g) for 14 consecutive days, other control animals received only water. The follow up study was carried out till 28 days. The results of this toxicity assessment indicate that there were no treatment related changes such as clinical signs, bodyweight, food intake, parameters pertaining to urine, hematological examinations, clinical chemistry, gross pathology and histopathology exhibited by experimental rats at both time intervals. Strain B. coagulans Unique IS-2 did not exhibit any clinical symptoms up to 1300 mg/kg b.w dose (5X109 CFU/gram), when administered for 14 days which was considered as ‘No Observed Adverse Effect Level’ (NOAEL). These results suggest that the strain B. coagulans Unique IS-2 may be considered as a non-pathogenic and safe for human consumption.

Molecular Typing and Probiotic Attributes of a New Strain of Bacillus coagulans – Unique IS-2: a Potential Biotherapeutic Agent

Genet Eng Biotechnol J. 2010 Jan 1; 7:1-20
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The genus Bacillus has been in use in the biotechnology industry for a very long time with a number of new cultures exhibiting a variety of benefits to humans. The present study focuses on phenotypic and genotypic characterization of a probiotic lactic acid bacteria, Bacillus coagulans (IS-2 a Unique-Biotech strain) isolated from human feces and contaminated soils. Probiotics are live microbes which when administered in adequate amounts confer a health benefit on the host and are increasingly used in nutraceuticals, functional foods or in microbial interference treatment. In addition to morphological and biochemical characterization, of this isolate, molecular characterization was done. In vitro assays performed to confirm the probiotic attributes of this isolate B.coagulans-Unique IS-2. The mole % G+C content of IS-2 strain was found to be 46 indicating the identity of the culture as Bacillus coagulans. PCR based amplification of the 16S rDNA, using universal primers, and sequencing done to study the diversity, as it allows identification of prokaryotes as well as the phylogenetic placement of the isolates. 16S rDNA sequence data was used to identify our lab isolates followed by RAPD profile of the new isolate- IS-2 of B. coagulans. The phylogenetic tree using Clustal W constructed by UPGMA based on the 16S rRNA gene sequence further confirmed that Unique Biotech strain IS-2 formed a coherent cluster with two other strains of B. coagulans namely B. coagulans ATCC 7050 and Bacillus coagulans NCIM 2030. Evaluation of its probiotic attributes revealed that Bacillus coagulans Unique IS-2 had promising Probiotic properties with reference to its survival in gastrointestinal conditions in the in-vitro assays and therefore offers excellent opportunities for its successful commercialization as a biotherapeutic agent.

Behavior of Bacillus coagulans Unique IS2 spores during passage through the simulator of human intestinal microbial ecosystem (SHIME) model

LWT - Food Science and Technology 124 (2020) 109196
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Survival and germination of spores in upper gastro intestinal tract (GIT) is crucial for spore-probiotics to confer beneficial effects to the host. In the present study, the survival, germination and metabolic activity of Bacillus coagulans Unique IS2 spores in an in vitro Simulator of Human Intestinal Microbial Ecosystem (SHIME®) model was investigated. The survival and germination of spores under fed and fasted GIT conditions was analyzed by using flow cytometry and agar plate method. Lactate and short chain fatty acid (SCFA) were measured as indicators of metabolic activity. B. coagulans Unique IS2 showed 102% and 99% survival under fed and fasted conditions of upper GIT. Significant amount of spore germination was detected in small intestine, where the spores had not transformed completely into vegetative cells but assisted in digestion of lactose and fructose. Furthermore, once the germinated spores entered into the colon they underwent vegetative growth and produced significant levels of lactate (8.30 ± 0.07 mM) and acetate (31.75 ± 3.58 mM) as major metabolites. In conclusion, B. coagulans Unique IS2 demonstrated ability to survive and germinate under gastrointestinal conditions and aid in digestion of carbohydrates

Bacillus clausii UBBC-07

Survival and Germination of Bacillus clausii UBBC07 Spores in in vitro Human Gastrointestinal Tract Simulation Model and Evaluation of Clausin Production

Frontiers in Microbiology, 11, 1010
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Bacillus clausii UBBC07 is a commercial spore probiotic known to reduce diarrhea in children and adults. In the present study, survival and germination of UBBC07 spores were investigated under fed and fasted conditions in Simulator of Human Intestinal Microbial Ecosystem. Besides this, lantibiotic production, purification, and characterization were performed. The agar plate analysis showed that spores were 100% tolerant to fed and fasted gastrointestinal tract (GIT) conditions. Simultaneously, flow cytometry revealed that at the end of small intestinal incubation, 120% (fed) and 133% (fasted) spores were in viable germinating state. The transformation of viable germinating spores into viable vegetative cells was observed at 3 h of incubation under fasted GIT conditions. In antimicrobial evaluation, UBBC07 produced low-molecularweight (2107.94 Da) class I lantibiotic clausin. The presence of lanB, lanC, and lanD genes confirms the clausin production. Clausin is stable at proteases (pepsin, proteinase K, and trypsin), temperature (up to 100◦C), and pH (up to 11). Furthermore, the antimicrobial activity toward Gram-positive bacteria including Clostridium difficile is advantageous. In conclusion, B. clausii UBBC07 spore probiotic is capable of surviving and germinating under in vitro upper GIT conditions. The clausin production justifies strain applicability in diarrhea.

Bacillus clausii UBBC-07 reduces severity of diarrhoea in children under 5 years of age: a double blind placebo controlled study

Beneficial microbes, 10(2), pp.149-154
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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.

Efficacy of Bacillus clausii strain UBBC-07 in the treatment of patients suffering from acute diarrhoea

Beneficial microbes, 4(2), pp.211-216
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The 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.

Saccharomyces boulardii Unique-28

Complete genome sequence and comparative genomics of the probiotic yeast Saccharomyces boulardii

Scientific reports, 7(1), p.371
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The probiotic yeast, Saccharomyces boulardii (Sb) is known to be effective against many gastrointestinal disorders and antibiotic-associated diarrhea. To understand molecular basis of probiotic-properties ascribed to Sb we determined the complete genomes of two strains of Sb i.e. Biocodex and unique28 and the draft genomes for three other Sb strains that are marketed as probiotics in India. We compared these genomes with 145 strains of S. cerevisiae (Sc) to understand genome-level similarities and differences between these yeasts. A distinctive feature of Sb from other Sc is absence of Ty elements Ty1, Ty3, Ty4 and associated LTR. However, we could identify complete Ty2 and Ty5 elements in Sb. The genes for hexose transporters HXT11 and HXT9, and asparagine-utilization are absent in all Sb strains. We find differences in repeat periods and copy numbers of repeats in flocculin genes that are likely related to the differential adhesion of Sb as compared to Sc. Core-proteome based taxonomy places Sb strains along with wine strains of Sc. We find the introgression of five genes from Z. bailii into the chromosome IV of Sb and wine strains of Sc. Intriguingly, genes involved in conferring known probiotic properties to Sb are conserved in most Sc strains.

Effect of a Locally Delivered Probiotic-Prebiotic Mixture as an Adjunct to Scaling and Root Planing in the Management of Chronic Periodontitis.

Journal of the International Academy of Periodontology, 18(3), 67-75
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The study aimed to determine the effi cacy of a probiotic, Saccharomyces boulardii (S. boulardii), mixed with a prebiotic, fructooligosaccharide (FOS), in the treatment of periodontal disease when used as an adjunct to non-surgical periodontal therapy (NSPT). Methods: The study was carried out on 30 subjects who were diagnosed as having chronic periodontitis and had at least two sites in two different quadrants with ≥ 5 mm probing pocket depth (PPD). Two sites in each subject were randomly selected: in control sites, scaling and root planing (SRP) was performed, while the study sites received SRP followed by placement of the probiotic mixture. The viability of the probiotic (S. boulardii) in the pocket (at baseline, 2 days, 4 days and 7 days after treatment) and in vitro (at baseline, 1 week and 2 weeks after treatment) was estimated at designated time periods. Site-specifi c measures of plaque, gingival infl ammation and periodontitis were recorded at baseline and specifi c intervals. Results: S. boulardii in vivo survived up to 4 days, while in vitro reduction in the mean counts of S. boulardii did not differ statistically from baseline to 14 days. Signifi cant reduction in probing pocket depths and gain in clinical attachment level in the test sites was observed when compared to controls. Conclusion: The results suggest that S. boulardii is effective in improving the clinical measures of periodontal disease. S. boulardii seems to thrive well in the subgingival environment and may function as an effective oral probiotic in subjects with periodontitis.

Oral consumption of potential probiotic Saccharomyces boulardii strain Unique 28 in patients with acute diarrhoea: a clinical report

Beneficial microbes, 3(2), 145-150
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The study was conducted to evaluate the efficacy and safety of Saccharomyces boulardii strain Unique 28 in patients suffering from acute diarrhoea. A total of 25 patients (average age 30.72±4.38 years) with symptoms of acute diarrhoea (≥3 loose motion in last 24 hours for <7 days) were included upon informed consent and ethical committee approval. All subjects were assigned to consume S. boulardii strain Unique 28 (5×109 cfu/capsule) twice a day for a duration of 10 days. Primary outcome measures such as duration of diarrhoea, frequency of defaecation, abdominal pain and consistency of stool were analysed on day 1, 3, 6 and 10 of the study. Secondary outcome measures were evaluated by assessment of incidence and type of adverse events (blood pressure and pulse rate), physical examination and clinical laboratory tests (complete blood count, glutamic-pyruvic transaminase, serum creatinine, stool examination and microscopy and these tests were performed on day 1 and 10 of the study. The results of the present study indicate that the mean duration of diarrhoea decreased from 34.20±4.25 to 9.40±3.00 (P<0.0001) min per day, frequency of defaecation decreased from 7.04±0.84 to 1.76±0.52 (P<0.0001) times a day, abdominal pain decreased from 3.28±1.06 (severe) to 0.72±0.50 (absent) (P<0.0001) and consistency of stool improved from 3.80±0.50 (watery) to 1.32±0.47 (soft) (P<0.0001). In addition, no significant changes in safety parameters were observed during treatment. Therefore, the present study concludes that S. boulardii strain Unique-28 might be useful in alleviating the symptoms of diarrhoea without any adverse effects.

Safety assessment studies of probiotic Saccharomyces boulardii strain Unique 28 in Sprague-Dawley rats

Beneficial microbes 2, no. 3 (2011): 221-227
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Strains of Saccharomyces boulardii, a probiotic yeast, have been found to be effective in the treatment of diarrhoea, inflammatory bowel disease, irritable bowel syndrome and other conditions. In the present study, Unique 28, a strain of S. boulardii isolated and characterised in our laboratory, was evaluated for its safety assessment. Acute and subacute toxicity tests were performed in rats. The dose of Unique 28 (5×109 cfu/g) fed orally was, up to 6,500 mg per kg of b.w. (body weight) for acute toxicity and up to 1,300 mg per kg of b.w. for sub-acute toxicity studies. This dose was well tolerated and there was no morbidity or any kind of toxic clinical symptoms displayed either in male or female rats. Moreover, the results of sub-acute toxicity studies using Unique 28 administered for 14 weeks indicated that there were no clear unwanted treatment related effects. Overall results of this toxicology assessment indicate that Unique 28 is safe for human consumption.

Lactobacillus salivarius UBLS-22

Effect of Probiotic Lactobacillus salivarius UBL S22 and Prebiotic Fructo-oligosaccharide on Serum Lipids, Inflammatory Markers, Insulin Sensitivity, and Gut Bacteria in Healthy Young Volunteers: A Randomized Controlled Single-Blind Pilot Study. 

Journal of Cardiovascular Pharmacology and Therapeutics, 20(3), 289-298
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The study investigated the effect of 6-week supplementation of a probiotic strain Lactobacillus salivarius UBL S22 with or without prebiotic fructo-oligosaccharide (FOS) on serum lipid profiles, immune responses, insulin sensitivity, and gut lactobacilli in 45 healthy young individuals. The patients were divided into 3 groups (15/group), that is, placebo, probiotic, and synbiotic. After 6 weeks, a significant reduction (P < .05) in total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides and increase in high-density lipoprotein cholesterol was observed in the probiotic as well as in the synbiotic group when compared to placebo; however, the results of total cholesterol and LDL-cholesterol were more pronounced in the synbiotic group. Similarly, when compared to the placebo group, the serum concentrations of inflammatory markers such as high sensitivity C-reactive protein, interleukin (IL) 6, IL-1b, and tumor necrosis factor a were significantly (P < .05) reduced in both the experimental groups, but again the reduction in the synbiotic group was more pronounced. Also, an increase (P < .05) in the fecal counts of total lactobacilli and a decrease (P < .05) in coliforms and Escherichia coli was observed in both the experimental groups after 6 weeks of ingestion. Overall, the combination of L salivarius with FOS was observed to be more beneficial than L salivarius alone, thereby advocating that such synbiotic combinations could be therapeutically exploited for improved health and quality of life.

Multistrain Probiotics

Effect of multi-strain probiotic (UB0316) in weight management in overweight/obese adults: a 12-week double blind, randomised, placebo-controlled study

Beneficial Microbes, 10(8), 855-866
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The 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 (waistto- 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.

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

PloS one, 14(11)
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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.

Effect of capsule 'UB03' containing potential probiotic strains for the treatment of patients with irritable bowel syndrome

Benef Microbes. :2(3):229-33
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The objective of this research was to study the efficacy and safety of capsule 'UB03' to treat patients with Irritable Bowel Syndrome (IBS). Thirty patients with Rome II IBS were assigned to receive capsule 'UB03' (10 billion lyophilised bacteria and yeast/capsule produced by Unique Biotech Limited, India) twice daily for 90 days. Assessment of IBS was carried out according with Rome II criteria and their severity for 90 days of treatment with an interval of 30 days. Complete haemogram, serum glutamic pyruvic transaminase, serum creatinine were performed as a part of safety evaluation at the time of inclusion and after 90 days of treatment. There was significant improvement in frequency of defecation (23%), consistency of stool, abdominal discomfort, bloating and flatulence. However, there was no significant change in abdominal pain and mucus in stool. This trial demonstrates that the consumption of capsule 'UB03' containing potential probiotic strains is found to be effective and safe for the treatment of patients with IBS.

Effect of oral supplementation of the probiotic capsule UB-01BV in the treatment of patients with bacterial vaginosis

Beneficial Microbes, June 2012; 3(2): 151-155
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Bacterial vaginosis (BV) is a common condition affecting millions of women annually and is characterised by a reduction in native lactobacilli. Antimicrobial therapy used to cure the disease is often found to be ineffective. We postulate that the potential probiotic capsule UB-01BV might be efficient in the treatment of BV. In the present study, 30 Indian women diagnosed with BV presenting symptoms such as white discharge, pH greater than 4.7, increased discharge, odour, colour of discharge and pruritus were included. All subjects were assigned to receive two potential probiotic capsules UB-01BV a day for 7 days. At the end of the treatment all subjects showed significant (P <0.001) positive response as revealed by a reduction in vaginosis symptoms. Therefore, the results of the present study provide the first preliminary evidence that the potential probiotic capsule UB-01BV can exert a significant reduction in vaginal infection.

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