A B C D E F G H I J K L M N O P Q R S T U V W X Y Z All
Devale, M.
- The Effect of Probiotic Bacillus subtilis HU58 on Immune Function in Healthy Human
Authors
1 Synergia Life Sciences Pvt. Ltd., IN
2 Synergia Life Sciences Pvt. Ltd, IN
3 Kokan Hospital, IN
4 Physicians Exclusive, LLC., IN
Source
The Indian Practitioner, Vol 70, No 9 (2017), Pagination: 15-20Abstract
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
Probiotic - Bacillus Subtilis HU58, Immune Function, Proinflammatory Cytokines (IL-6, TNF-α).
References
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- A Study of Probiotic Bacillus subtilis HU58 for the Management of Antibiotic-Associated Diarrhoea in Adults
Authors
1 Synergia Life Sciences Pvt. Ltd., IN
2 Kokan Hospital, IN
Source
The Indian Practitioner, Vol 73, No 4 (2020), Pagination: 22-28Abstract
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
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