Observational study to assess efficacy and safety of Bifidobacterium longum W11 plus Fructooligosaccharide combination in patients with irritable bowel syndrome (IBS)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Abbott India Ltd
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change in mean IBS-SSS total score from baseline at Day 30
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients of either sex, aged between 18 and 60 years OPD Patients with confirmed diagnosis of IBS with any of the three subtypes (viz IBS D/IBS C/IBS M) Patients with no improvement in symptoms despite treatment with antispasmodics.
Exclusion Criteria
- •Patients will be excluded if they have severe respiratory insufficiency organic brain damage sleep apnea syndrome severe acute or chronic hepatic insufficiency (risk of occurrence of encephalopathy) myasthenia gravis chronic psychosis major depressive episodes phobic or obsessional states or dementia Patients with other pre-existing GI disorders GI surgery abnormal upper and lower GI endoscopy finding family history of colon cancer or inflammatory bowel disease symptoms that discriminate lower GI organic diseases from IBS such as blood in stool nighttime symptoms that cause sleep disturbance unintentional weight loss or change in typical IBS symptoms such as new and/or different pain and alcohol or drug-dependency.
Outcomes
Primary Outcomes
Change in mean IBS-SSS total score from baseline at Day 30
Time Frame: Day 0, Day 30
Secondary Outcomes
- Change in mean IBS-SSS total score from baseline at Day 15.(Change in mean score for each of the parameters in IBS-SSS (abdominal pain, number of days of abdominal pain, severity of abdominal distention, dissatisfaction with bowel habits, and)
Investigators
Dr Ramesh Garg
Liver Gastro Clinic