The Indian Practitioner

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A Study of Probiotic Bacillus subtilis HU58 for the Management of Antibiotic-Associated Diarrhoea in Adults


Affiliations
1 Synergia Life Sciences Pvt. Ltd., India
2 Kokan Hospital, India
     

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Aim: To evaluate the effectiveness of a novel probiotic Bacillus subtilis HU58 in an open-labelled placebo-controlled trial in a group of 60 patients with Antibiotic Associated Diarrhoea (AAD).

Materials and Methods: The study was conducted in 60 patients suffering from AAD. Patients received either Probiotic Bacillus subtilis HU58 (2 × 109 CFU/Cap) or placebo for 7 days and followed up to 15th day. Stool consistency was recorded during the baseline, 3rd day, 7th day and 15th day and analyzed according to the Bristol stool chart. The trial was approved by an Independent Ethics Committee and registered with CTRI. Before enrolment, an informed written consent was obtained from the patients.

Results: Stool consistency as assessed according to the Bristol stool chart had decreased in the probiotic treated group (p < 0.0001) as compared to the placebo group (p = 0.8003). At baseline the stool consistency measurements according to the Bristol stool chart in both groups (probiotic group and placebo group) were found to be 7. The stool frequency had reduced from 7-8 stools per day to 1-2 stools per day. Significant improvement was observed in 16 patients (scale 4), mild improvement observed in 6 patients (scale 5) and no improvement was observed in 8 patients (scale 6) as observed till the 15th day. There was no reduction of score in the placebo group (scale 7) till the 15th day. Also the stool frequency in this group had just reduced from 7-8 stools to 3-4 stools per day.

Conclusions: This study had shown that Probiotic Bacillus subtilis HU58 at a dose of 2 × 109 CFU/Cap once a day for 7 days was well tolerated and safe and compared to placebo the probiotic group significantly showed a reduced incidence of AAD.


Keywords

Probiotic Bacillus subtilis HU58, Antibiotic Associated Diarrhoea (AAD), Colony Forming Units (CFU), Bristol Stool Chart, Stool Consistency.
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  • Fox MJ, Ahuja KDK, Robertson IK et al. Can probiotic yogurt prevent diarrhoea in children on antibiotics? A double- blind, randomised, placebo controlled study. BMJ Open 2015; 5:e006474. doi:10.1136/bmjopen-2014-006474

  • Mcfarland L. Epidemiology, Risk factors and treatments for Antibiotic-Associated Diarrhoea. Dig Dis 1998; 16(5):292-307.

  • Blaabjerg S, Artzi DM, Aabenhus R. Probiotic for the prevention of Antibiotic-Associated Diarrhoea in outpatients-A Systemic Review and Meta-Analysis. Antibiotic 2017; 6(4): 1-17.

  • Despande A, Pimentel R, Choure A. Antibiotic-Associated Diarrhoea and Clostridium Difficile. Gastroenterology 2014; 154.

  • Alam S, Mushtaq M. Antibiotic Associated Diarrhoea in Children. Indian Pediatr 2009; 46: 491-6.

  • Turk D, Bernet JP, Marx J, Kempf H, Giard P, Walbaum O et al. Incidence and risk factors of oral antibiotic-associated diarrhoea in an outpatient pediatric population. J Pediatr Gastroenterol Nutr 2003; 37(1): 22-6.

  • Sullivan A, Nord CE. Probiotics and gastrointestinal diseases. J Intern Med 2005; 257(1): 78-92.

  • Sniffen JC, McFarland LV, Evans CT, Goldstein EJC. Choosing an appropriate probiotic product for your patient: An evidence based practical guide. PLoS ONE 2018; 13(12): e0209205.

  • Wang CR, Jin J. Effect of Medilac-S on diarrhoea caused by an imbalance of intestinal flora. Journal of Medical Forum 2006; 27: 74-5.

  • He GZ, He YH. Clinical analysis of 112 cases of chronic diarrhoea treated by Medilac-S. Hainan Medical Journal 2008; 19: 14-46.

  • Miller LE, Ibarra A, Ouwehand AC, Zimmermann AK. Normative values for stool frequency and form using Rome III diagnostic criteria for functional constipation in adults: systemic review with meta-analysis. Ann Gastroenterol 2017; 30(2): 161-7.

  • Chen CC, Kong MS, Lai MW, Chao HC, Chang KW, Chen SY, et al. Probiotics have clinical, microbiologic, and immunologic efficacy in acute infectious diarrhoea. The Pediatric infectious disease journal. 2010; 29(2): 135–8.

  • Cutting SM. Bacillus probiotics. Food microbiology. 2011; 28(2): 214–20.

  • D’Arienzo R, Maurano F, Mazzarella G, Luongo D, Stefanile R, Ricca E, et al. Bacillus subtilis spores reduce susceptibility to Citrobacter rodentium-mediated enteropathy in a mouse model. Research in microbiology. 2006; 157(9): 891–7.

  • La Ragione RM, Woodward MJ. Competitive exclusion by Bacillus subtilis spores of Salmonella enteric serotype Enteritidis and Clostridium perfringens in young chickens. Veterinary microbiology. 2003; 94(3): 245–56.

  • La Ragione RM, Casula G, Cutting SM, Woodward MJ. Bacillus subtilis spores competitively exclude Escherichia coli O78:K80 in poultry. Veterinary microbiology. 2001; 79(2): 133–42.

  • Pinchuk IV, Bressollier P, Verneuil B, Fenet B, Sorokulova 2020IB, Megraud F et al. In vitro anti-Helicobacter pylori activity of the probiotic strain Bacillus subtilis 3 is due to secretion of antibiotics. Antimicrobial agents and chemotherapy. 2001; 45(11): 3156–61.

  • Hong, H. A., R. Khaneja, N. M. Tam, A. Cazzato, S. Tan, M. Urdaci, A. Brisson, A. Gasbarrini, I. Barnes & S. M. Cutting, (2009a) Bacillus subtilis isolated from the human gastrointestinal tract. Res Microbiol 160(2): 134-143.

  • Hong, H. A., E. To, S. Fakhry, L. Baccigalupi, E. Ricca & S. M. Cutting, (2009b) Defining the natural habitat of Bacillus spore-formers. Res Microbiol 160(6): 375-379.

  • Dound Y, Jadhav SS, Devale M, Bayne T, Krishnan K, Mehta DS. The effect of probiotic Bacillus subtilis HU58 on immune function in healthy human. The Indian Practitioner 2017; 70(9): 15-20.

  • Tompkins TA, Xu X, Ahmarani J. A comparative review of post-market clinical studies performed in adults with an Asian probiotic formulation. Beneficial Microbes 2010; 1(1): 93-106.

  • Bignardi GE. Risk factor for Clostridium difficile infection. J Hosp Infect 1998; 40(1): 1-15.

  • EL Hage R, Hernandez-Sanabria E, Van de Wiele T. Emerging trends in “Smart Probiotics”: Functional Consideration for the Development of Novel Health and Industrial Applications. Front Microbiol 1889; 8: 1-11.

  • Hickson M. Probiotics in the prevention of antibiotic-associated diarrhoea and Clostridium difficile infection. Ther Adv Gastroenterol 2011; 4(3): 185-97.

  • Binder HJ. Role of colonic short-chain fatty acid transport in diarrhoea. Ann Rev Physiol 2010; 72: 297–313.

  • Graul T, Cain AM, Karpa KD. Lactobacillus and bifidobacteria combinations: A strategy to reduce hospital-acquired Clostridium difficile diarrhoea incidence and mortality. Med Hypotheses 2009; 73(2): 194–8.

  • Ruszczynski M, Radzikowski A, Szajewska H. Clinical trial: effectiveness of Lactobacillus rhamnose (strains E/N, Oxy and Pen) in the prevention of antibiotic-associated diarrhoea in children. Aliment Pharmacol Ther 2008; 28: 154-61.

  • Horosheva TV, Vodyanoy V, Sorokulova I. Efficacy of Bacillus probiotics in prevention of antibiotic-associated diarrhoea: a randomized, double-blind, placebo-controlled clinical trial. JMM Case Report 2014; 4: 1-6.

  • Evans M, Salewski RP, Christman MC, Girard SA, Tompkins TA. Effectiveness of Lactobacillus helveticus and Lactobacillus rhamnosus for the management of antibiotic-associated diarrhoea in healthy adults: a randomised, doubleblind, placebo-controlled trial. Br J Nutr 2016; 116(1): 94-103.

  • Cuetas AM, Deaton J, Khan S, Davidson J, Ardita C. The effect of Bacillus subtilis DE111 on the daily bowel movement profile for people with occasional gastrointestinal irregularity. J Prob Health 2017; 5(4): 189.

  • Zang DM, Xu BB, Yu L, Zheng LF, Chen LP, Wang W. A prospective control study of Saccharomyces boulardii in prevention of antibiotic-associated diarrhoea in the older inpatients. Zhonghua Nei Ke Za Zhi 2017; 56(6): 398-401.


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  • A Study of Probiotic Bacillus subtilis HU58 for the Management of Antibiotic-Associated Diarrhoea in Adults

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Authors

D. S. Mehta
Synergia Life Sciences Pvt. Ltd., India
A. de Souza
Synergia Life Sciences Pvt. Ltd., India
S. S. Jadhav
Synergia Life Sciences Pvt. Ltd., India
M. Devale
Kokan Hospital, India

Abstract


Aim: To evaluate the effectiveness of a novel probiotic Bacillus subtilis HU58 in an open-labelled placebo-controlled trial in a group of 60 patients with Antibiotic Associated Diarrhoea (AAD).

Materials and Methods: The study was conducted in 60 patients suffering from AAD. Patients received either Probiotic Bacillus subtilis HU58 (2 × 109 CFU/Cap) or placebo for 7 days and followed up to 15th day. Stool consistency was recorded during the baseline, 3rd day, 7th day and 15th day and analyzed according to the Bristol stool chart. The trial was approved by an Independent Ethics Committee and registered with CTRI. Before enrolment, an informed written consent was obtained from the patients.

Results: Stool consistency as assessed according to the Bristol stool chart had decreased in the probiotic treated group (p < 0.0001) as compared to the placebo group (p = 0.8003). At baseline the stool consistency measurements according to the Bristol stool chart in both groups (probiotic group and placebo group) were found to be 7. The stool frequency had reduced from 7-8 stools per day to 1-2 stools per day. Significant improvement was observed in 16 patients (scale 4), mild improvement observed in 6 patients (scale 5) and no improvement was observed in 8 patients (scale 6) as observed till the 15th day. There was no reduction of score in the placebo group (scale 7) till the 15th day. Also the stool frequency in this group had just reduced from 7-8 stools to 3-4 stools per day.

Conclusions: This study had shown that Probiotic Bacillus subtilis HU58 at a dose of 2 × 109 CFU/Cap once a day for 7 days was well tolerated and safe and compared to placebo the probiotic group significantly showed a reduced incidence of AAD.


Keywords


Probiotic Bacillus subtilis HU58, Antibiotic Associated Diarrhoea (AAD), Colony Forming Units (CFU), Bristol Stool Chart, Stool Consistency.

References