Health Condition 1: K519- Ulcerative colitis, unspecified
Conditions
Interventions
Intervention1: Bifidobacterium
longum W11 + Fructo-oligosaccharide (2.5g): FloraChampTM (Bifidobacterium longum W11 (5 bn) Fructo-oligosaccharide 2.5g), one sachet per day for 1 month to be given ora
Sponsors
Abbott India Ltd
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean IBS-SSS total score from baseline at Day 30Timepoint: Day 0, Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 interference with Quality of Life) from baseline at Day 15 and Day 30 Proportion of patients showing normalization of stool form and frequency Number and percentage of patients who discontinue study treatment due to AE Global tolerability assessment by patients and investigators at Day 30Timepoint: Day 0, Day 15, Day 30 | — |
Countries
India
Contacts
Public ContactJawahar Nidamboor
Liver Gastro Clinic
Outcome results
None listed