Lactobacillus casei strain Shirota – Research Update IMPROVEMENT IN INTESTINAL HEALTH 1. A Lactobacillus casei Shirota probiotic drink reduces antibiotic- associated diarrhoea in patients with spinal cord injuries: a randomised controlled trial

Certain probiotics may prevent the development of antibiotic-associated diarrhoea (AAD) and Clostridium difficile-associated diarrhoea (CDAD), but their effectiveness depends on both strain and dose. There are few data on nutritional interventions to control AAD/CDAD in the spinal cord injury (SCI) population. The present study aimed to assess the efficacy of consuming a commercially produced probiotic containing at least 6·5 billion live Lactobacillus casei Shirota (LcS) in reducing the incidence of AAD/CDAD, and whether undernutrition and proton pump inhibitors (PPI) are risk factors for AAD/CDAD. A total of 164 SCI patients (50·1 (SD 17·8) years) with a requirement for antibiotics (median 21 d, range 5–366) were randomly allocated to receive LcS (n 76) or no probiotic (n 82). LcS was given once daily for the duration of the antibiotic course and continued for 7 days thereafter. Nutritional risk was assessed by the Spinal Nutrition Screening Tool. The LcS group had a significantly lower incidence of AAD (17·1 v. 54·9%, P 0·001). At baseline, 65% of patients were at undernutrition risk. Undernutrition (64·1 v. 33·3%, P0·01) and the use of PPI (38·4 v. 12·1%, P1⁄40·022) were found to be associated with AAD. However, no significant difference was observed in nutrient intake between the groups. The multivariate logistic regression analysis identified poor appetite (1/2 meals eaten) (OR 5·04, 95% CI 1·28, 19·84) and no probiotic (OR 8·46, 95% CI 3·22, 22·20) as the independent risk factors for AAD. The present study indicated that LcS could reduce the incidence of AAD in hospitalized SCI patients. A randomised, placebo-controlled study is needed to confirm this apparent therapeutic success in order to translate into improved clinical outcomes. 2. Role of probiotic in preventing acute diarrhoea in children: a community-based, randomized, double-blind placebo-controlled field trial in an urban slum. Sur D et al (2011) Epidemiology and Infection 139: 919-926. Abstract Acute diarrhoea remains a major public health challenge in developing countries. We examined the role of a probiotic in the prevention of acute diarrhoea to discover if there was an effect directed towards a specific aetiology. A double-blind, randomized, controlled field trial involving 3758 children aged 1-5 years was conducted in an urban slum community in Kolkata, India. Participants were given either a probiotic drink containing Lactobacillus casei strain Shirota or a nutrient drink daily for 12 weeks. They were followed up for another 12 weeks. The primary outcome of this study was the occurrence of first episodes of diarrhoea. We assessed this during 12 weeks of intake of study agent and also for 12 weeks of follow-up. There were 608 subjects with diarrhoea in the probiotic group and 674 subjects in the nutrient group during the study period of 24 weeks. The level of protective efficacy for the probiotic was 14% (95% confidence interval 4-23, P<0·01 in adjusted model). The reduced occurrence of acute diarrhoea in the probiotic group compared to nutrient group was not associated with any specific aetiology. No adverse event was observed in children of either probiotic or nutrient groups. The study suggests that daily intake of a probiotic drink can play a role in prevention of acute diarrhoea in young children in a community setting of a developing country.Acute diarrhoea remains a major public health challenge in developing countries. We examined the role of a probiotic in the prevention of acute diarrhoea to discover if there was an effect directed towards a specific aetiology. A double-blind, randomized, controlled field trial involving 3758 children aged 1-5 years was conducted in an urban slum community in Kolkata, India. Participants were given either a probiotic drink containing Lactobacillus casei strain Shirota or a nutrient drink daily for 12 weeks. They were followed up for another 12 weeks. The primary outcome of this study was the occurrence of first episodes of diarrhoea. We assessed this during 12 weeks of intake of study agent and also for 12 weeks of follow-up. There were 608 subjects with diarrhoea in the probiotic group and 674 subjects in the nutrient group during the study period of 24 weeks. The level of protective efficacy for the probiotic was 14% (95% confidence interval 4-23, P<0·01 in adjusted model). The reduced occurrence of acute diarrhoea in the probiotic group compared to nutrient group was not associated with any specific aetiology. No adverse event was observed in children of either probiotic or nutrient groups. The study suggests that daily intake of a probiotic drink can play a role in prevention of acute diarrhoea in young children in a community setting of a developing country. 3. Effect of Lactobacillus casei Shirota on colonic transit time in patients with chronic constipation Krammer HJ et al (2011) Coloproctology 33: 109-113. Abstract Background. Slow-transit constipation (STC) is caused by a motility disorder of the colon which leads to delayed transit (>72 h). The probiotic strain Lactobacillus casei Shirota (LcS) has been shown to improve constipation-related symptoms, such as stool frequency and consistency. A randomized double-blind placebo-controlled trial was performed to determine the effect of LcS on the colonic transit time in patients with STC.Background. Slow-transit constipation (STC) is caused by a motility disorder of the colon which leads to delayed transit (>72 h). The probiotic strain Lactobacillus casei Shirota (LcS) has been shown to improve constipation-related symptoms, such as stool frequency and consistency. A randomized double-blind placebo-controlled trial was performed to determine the effect of LcS on the colonic transit time in patients with STC. Patients and methods. Colonic transit time of all consecutive outpatients with chronic constipation was determined by the Hinton test using radiopaque markers. Patients with a transit time longer than 72 h were included in the study. A total of 24 patients received either a dairy drink containing 6.5×109 colony forming units (cfu) of LcS or a placebo daily for 4 weeks. General gastrointestinal symptoms were evaluated weekly by a questionnaire and the measurement of colonic transit time was repeated after the intervention. Results. The intake of LcS resulted in a significant acceleration of the total colonic transit time from 95.6 h to 76.5 h (p=0.05). This effect was most pronounced in the sigmoid and rectum transit time (p<0.007). no statistically significant change in the total colonic transit time was observed (before: 95.8 h, after: 87.1 h, p=0.282) In the placebo group. Conclusion. The daily intake of a probiotic drink containing LcS significantly reduced the colonic transit time in patients with STC. 4. Probiotic beverage containing Lactobacillus casei Shirota improves gastrointestinal symptoms in patients with chronic constipation. Koebnick C, Wagner I, Leitsmann P, Stern U, Zunfit HJF (2003) Canadian Journal of Gastroenterology 17(11): 655-659. Summary BACKGROUND: The aim of the present study was to investigate the effect of a probiotic beverage on gastrointestinal symptoms in patients with chronic constipation. METHODS: A double-blind, placebo-controlled, randomized study was conducted over a four-week period in patients with symptoms of chronic constipation (n=70). To all patients, 65 mL/day of a probiotic beverage containing Lactobacillus casei Shirota (LcS) or a sensorially identical placebo was administered. Patients completed a questionnaire on gastrointestinal symptoms, well-being and stool habits and underwent a medical examination weekly. Severity of constipation, flatulence and bloating was summarized into four categories (severe, moderately severe, mild and no symptoms). RESULTS: The consumption of LcS resulted in a significant improvement in self-reported severity of constipation and stool consistency, starting in the second week of the intervention phase (P<0.0001). Severe and moderately severe constipation was observed less in the LcS group. The occurrence and degree of flatulence or bloating sensation did not change. In the final examination, 89% of the LcS group and 56% of the placebo group showed a positive effect of their beverage on constipation (P=0.003). No adverse reactions were reported. CONCLUSIONS: The results indicate a beneficial effect on gastrointestinal symptoms of patients with chronic constipation. The administration of probiotic foodstuffs may be recommended as an adjunctive therapy of chronic constipation. 5. Fermented milk containing Lactobacillus casei strain Shirota reduces incidence of hard or lumpy stools in healthy population. Sakai T et al (2011) Int. J. Food Sci. Nutr. 62(4): 423-430. Abstract The objective of the present study was to investigate the efficacy of fermented milk containing Lactobacillus casei strain Shirota (LcS) in a healthy population. Healthy subjects with Bristol Stool Form Scale (BS) score < 3.0 were randomized to fermented milk treatment for 3 weeks or non-intervention control. The primary endpoint was the proportion of subjects that produced hard or lumpy stools (HLS) ≥ 25% of bowel movements (H-HLS). Secondary endpoints included changes in BS score, constipationrelated symptom scores and stool parameters. Efficacy was analyzed in 39 subjects. AfterThe objective of the present study was to investigate the efficacy of fermented milk containing Lactobacillus casei strain Shirota (LcS) in a healthy population. Healthy subjects with Bristol Stool Form Scale (BS) score < 3.0 were randomized to fermented milk treatment for 3 weeks or non-intervention control. The primary endpoint was the proportion of subjects that produced hard or lumpy stools (HLS) ≥ 25% of bowel movements (H-HLS). Secondary endpoints included changes in BS score, constipationrelated symptom scores and stool parameters. Efficacy was analyzed in 39 subjects. After 3 weeks of treatment the proportion of H-HLS subjects had significantly decreased from 73.7% to 36.8%, whereas in the control group the proportion had increased from 75.0% to 85.0% during the same period (P = 0.002). The BS score was significantly improved after the treatment compared with the control (P < 0.001). In conclusion, daily consumption of fermented milk containing LcS reduced the incidence of HLS. 6. Effect of the continuous intake of probiotic-fermented milk containing Lactobacillus casei strain Shirota on fever in a mass outbreak of norovirus gastroenteritis and the faecal microflora in a health service facility for the aged. Nagata S et al (2011) Brit J Nutr 1(8): 1-8.