Open Access
Subscription Access
Open Access
Subscription Access
The Effect of Probiotic Bacillus subtilis HU58 on Immune Function in Healthy Human
Subscribe/Renew Journal
Objective: Probiotic - Bacillus subtilis is known to modulate the immune function. The current study evaluates the role of Bacillus subtilis HU58 on immune function in healthy human and also for its safety and tolerability along with clinical variables.
Material and Method: An open-labeled trial was conducted in 18 apparently healthy subjects. Probiotic-Bacillus subtilis HU58 capsules were supplied by Synergia Life Sciences Pvt. Ltd. Each capsule contained 2 billion cfu of Probiotic- Bacillus subtilis HU58. These capsules were given once a day orally for 8 weeks. Blood biochemical and organ function tests including Proinflammatory cytokines (IL-6, TNF-α), NK Cell count, ESR, CBC, Lipid profile, HbA1c, Liver function test, S. Creatinine, Seropositivity (HIV, HCV, HBcAg) were studied at the baseline, at fourth week and at eight week. Prior to the study, the permission from Intersystem BioMedica Ethics Committee (ISBEC/NR-05/KM-VM/2016), Vile Parle, Mumbai was obtained. This study was registered with Clinical Trial Registry of India (CTRI) (CTRI/2016/12/007518). Informed written consent was obtained from the subjects before enrollment.
Results: At the end of 8th week it was observed that there is reduction in IL-6 by around 45 % and TNF-α by 55 % and continues to decrees. The reduction was found to be statistically significant (P<0.0001). Probiotic - Bacillus subtilis HU58 was well tolerated clinically and found to be safe as per the organ function tests in all the subjects. No serious adverse events were reported during the period of therapy.
Conclusion: This preliminary study has shown that Probiotic-Bacillus subtilis HU58 at a dose of 2 billion cfu once a day for 8 weeks was found to be well tolerated and without any side effects. However, the therapeutic efficacy needs to be evaluated further in a larger sample size and with disease specific indications.
Keywords
- Hong HA, LH Duc, Cutting SM (2005). The use of bacterial spore formers as probiotics. FEMS Microbiol, Rev 29; 813-835.
- Mazza P (1994). The use of Bacillus subtilis as an antidiarrhoeal microorganism. Boll Chim Farmaceutico, 133; 3-18.
- Sanders ME, Morelli L, Tompkins TA (2003). Sporeformers as human probiotics: Bacillus, Sporolactobacillus, and Brevibacillus. Comprehen Rev Food Sci Food Saf, 2; 101-110.
- Barbosa TM, Serra CR, La Ragione RM, Woodward MJ, Henriques AO (2005). Screening for bacillus isolates in the broiler gastrointestinal tract. Appl Environ Microbiol, 71; 968-978.
- Spinosa MR, Braccini T, Ricca E, De Felice M, Morelli L, Pozzi G, Oggioni MR (2000). On the fate of ingested Bacillus spores. Res Microbiol, 151; 361-368
- Tuohy KM, Pinart-Gilberga M, Jones M, Hoyles L et al (2007). Survivability of a probiotic Lactobacillus casei in the gastrointestinal tract of healthy human volunteers and its impact on the faecal microflora. J Appl Microbiol, 102; 1026-1032.
- Pie, S., A. Awati, S. Vida, I. Falluel, B. A. Williams, and I. P. Oswald. 2007. Effects of added fermentable carbohydrates in the diet on intestinal proinflammatory cytokine-specific mRNA content in weaning piglets. J. Anim. Sci. 85:673–683.
- Hanson, P. J., A. P. Moran, and K. Butler. 2011. Paracellular permeability is increased by basal lipopolysaccharide in a primary culture of colonic epithelial cells; an effect prevented by an activator of Tolllike receptor-2. Innate Immun. 17:269–282.
- Carol, M., Borruel, N., Antolin, M., Llopis, M., Casellas, F., Guarner, F., and Malagelada, J.R. (2006). Modulation of apoptosis in intestinal lymphocytes by a probiotic bacteria in Crohn’s disease. J Leukoc Biol 79, 917-922.
- Christensen, H.R., Frokiaer, H., and Pestka, J.J. (2002). Lactobacilli differentially modulate expression of cytokines and maturation surface markers in murine dendritic cells. J Immunol 168, 171-178.
- Farkas O, Mátis G, Pászti-Gere E, Palócz O, Kulcsár A, Petrilla J, Csikó G, Neogrády Z, Gálfi P. Effects of Lactobacillus plantarum 2142 and sodium n-butyrate in lipopolysaccharide-triggered inflammation: comparison of a porcine intestinal epithelial cell line and primary hepatocyte monocultures with a porcine enterohepatic co-culture system. J Anim Sci. 2014 Sep;92(9):3835-45.
- Resta-Lenert S and Barrett KE. Probiotics and commensals reverse TNF-alpha- and IFN-gammainduced dysfunction in human intestinal epithelial cells. Gastroenterology. 2006 Mar; 130(3): 731-46.
- Rodes L, Khan A, Paul A. et al Effect of probiotics Lactobacillus and Bifidobacterium on gut-derived lipopolysaccharides and inflammatory cytokines: an in vitro study using a human colonic microbiota model. J Microbiol Biotechnol. 2013 Apr;23(4):518-26.
- Mardem Machado de Souza, José Eduardo de AguilarNascimento, Diana Borges Dock-Nascimento. Effects of budesonide and probiotics enemas on the systemic inflammatory response of rats with experimental colitis. 2007. Acta Cirúrgica Brasileira - Vol 22 (Supplement 1): 40-45.
- Wang IK, Wu YY, Yang YF, Ting IW, Lin CC, Yen TH et al. The effect of probiotics on serum levels of cytokine and endotoxin in peritoneal dialysis patients: A randomised, double-blind, placebo-controlled trial. Beneficial microbes. 2015;6(4):423-430.
- Sanaie S, Ebrahimi-Mameghani M, Hamishehkar H, Mojtahedzadeh M, Mahmoodpoor A. Effect of a multispecies probiotic on inflammatory markers in critically ill patients: A randomized, double-blind, placebocontrolled trial. Journal of Research in Medical Sciences : The Official Journal of Isfahan University of Medical Sciences. 2014;19(9):827-833.
- Arima K, Kakinuma A, Tamura G (1968) Surfactin, a crystalline surfactant peptidelipid Produced by Bacillus subtilis: isolation, characterization and its inhibition of Brin Clot formation. Biochem Biophys Res Commun . Commun. 31(3): 488-494. 31 (3): 488-494.
- Hong, H. A., J.-M. Huang, R. Khaneja, L. V. Hiep, M. C. Urdaci & S. M. Cutting, (2008) The safety of Bacillus subtilis and Bacillus indicus as food probiotics. Journal of Applied Microbiology 105: 510-520.
- Tam, N.M.K., Uyen, N.Q., Hong, H.A., Duc, L.H., Hoa, T.T., Serra, C.H., Henriques, A.O., Cutting, S.M. (2006) The intestinal life cycle of Bacillus subtilis close relatives. J. Bacteriol. 188, 2692-2700.
- 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: 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: 375-379.
Abstract Views: 2002
PDF Views: 3