The effect of Probiotic Bacillus subtilis HU58 on Immune function in Healthy Human

Abstract

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.