Effect of Bacillus coagulans Unique IS-2 in Inflammatory Bowel Disease (IBD): A Randomized Controlled Trial

Probiotic intervention is an important approach for the treatment and health restoration in inflammatory bowel disease (IBD). The preventive and therapeutic effects of probiotic Bacillus coagulans Unique IS-2 in different diseases have been well recognized but its efficacy in IBD is unreported. Therefore, a study was conducted to assess the effect of Bacillus coagulans Unique IS-2 in IBD patients. Subjects those satisfying compliance criteria were recruited in the study and given either probiotic B. coagulans Unique IS-2 or placebo for 4 weeks as per randomization. Survival of the given probiotic strain in GI, presence of beneficial gut bacteria, serum cytokines, serum serotonin and serum dopamine, symptoms of disease, physical, behavioral and psychological parameters of the subjects were evaluated before and after intervention. In this study B. coagulans Unique IS-2 was well tolerated with no severe adverse events in IBD patients. B coagulans Unique IS-2 demonstrated good survival in GI tract by significantly high detection in probiotic treated group (p <0.001). Significant enhancement in beneficial Lactobacilli was observed in probiotic treated group (p <0.01). NGS data and metagenomic analysis also showed an increase in the abundance of bacterial genera Bacillus, Lactobacillus, Bifidobacterium, Faecalibacterium, Bacteroides, Megamonas, Lachnospira, Blautia and Alistipes in the post intervention samples in the treatment group. A decrease in in the abundance of bacterial genera Sutterella, Dialister, Roseburia and Megasphaera was observed in post intervention samples in the treatment group. Increased secretion of cytokine IL-10 and variable decrease in the secretion of IL-6, IL-1{beta}, TNF-, IL-17 and IL-23 was observed in in the probiotic treated group. Post intervention change in serum serotonin and serum dopamine was not significant in both the groups. A reduction in the severity of disease symptoms and improvement in the physical, behavioral and psychological parameter was observed in the probiotic treated group. The observed results demonstrated that B. coagulans Unique IS-2 with SMT was effective in adult IBD patients. Study was registered with Clinical Trials Registry India (CTRI) - (registration reference-REF/2016/09/012181, CTRI registration No.-CTRI/2019/11/022087).