Observational study to assess efficacy and safety of Bifidobacterium longum W11 plus Fructooligosaccharide combination in patients with irritable bowel syndrome (IBS)

Irritable bowel syndrome (IBS) is a common condition, which leads to significant morbidity, work absenteeism, loss of productivity, and economic burden to the society and impacts the quality of life of patients. According to a systemic review, the bowel of patients with IBS is populated with potentially harmful microbiota (Enterobacteriaceae [Escherichia, Shigella, Campylobacter, and Salmonella], Lactobacillaceae and Bacteroides). It has been observed that Bifidobacterium and Faecalibacterium tend to decrease in patients with IBS. Probiotics are proven to have a beneficial impact on global IBS symptoms, abdominal pain, and flatulence. Among bacteria with a potential therapeutic effect, Bifidobacteria have certainly played a key role for several decades. Studies on regular consumption of fructo-oligosaccharides with minor bowel disorders have shown that regular consumption may improve Quality of life and digestive comfort in patients with IBS. Currently, there are no Indian clinical studies done using this combination. This study will provide the efficacy and safety data of the B. longum W11 plus Fructooligosaccharide combination in Indian IBS patients

The primary objectives of this study is the improvement in global IBS symptoms compared to baseline. The Secondary Objective of this study is to decrease the pain in abdomen compared to baseline, Proportion of patients showing improvement in abdominal distension, Proportion of patients showing normalization of stool form and frequency