Health Condition 1: null- Irritable Bowel Syndrome Health Condition 2: K58- Irritable bowel syndrome
Conditions
Interventions
Intervention1: Test: SPILs VSL#3 capsule: SPILs VSL#3 capsule, containing 112.5 x 109 cfu/g of viable lyophilized bacteria (Each dose corresponds to 2 capsules equivalent to 225 billion viable lyophil
Sponsors
Sun Pharma Industries Limited
Eligibility
Inclusion criteria
Inclusion criteria: 18-75 years old; Females of childbearing potential with negative pregnancy blood test within 48hours of each transit study Present or previous chronic gastrointestinal symptoms suggestive of IBS using Rome III criteria Lower abdominal bloating associated with visible distension > 25% of time during the prior 12 months on symptom questionnaire Moderate to severe abdominal bloating symptom (average score of at least 24 out of 100 on a bloating VAS scale during the 2 week run-in period) Patient with non-constipating IBS (Constipation defined as no less than 3 stools/week) No previous abdominal surgery except appendectomy, Caesarian section, tubal ligation, laparoscopic cholecystectomy, hysterectomy, or abdominal wall herniarepair.
Exclusion criteria
Exclusion criteria: Abdominal surgery other than appendectomy, Caesarian section, abdominal wall hernia repair, laparoscopic cholecystectomy, hysterectomy, or tubal ligation Lower abdominal bloating associated with visible distension 25% of time during the prior 12 months on symptom questionnaire Average bloating score less than 24 out of 100 on a VAS scale during the 2week run-in period Positive history of non-functional bowel diseases e.g. Crohnâ??s disease, cancer Subjects having less than 3 stools/week Use of medications that may alter gastrointestinal motility Use of anitbiotics within 12 weeks or probiotics within 8 weeks of study enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AVERAGE DAILY score of abdominal bloating severity scoreTimepoint: baseline vs. post-treatment (week 8) | — |
Secondary
| Measure | Time frame |
|---|---|
| change in scores of abdominal flatulenceTimepoint: baseline vs. post-treatment (week 8);changes in scores of abdominal painTimepoint: baseline vs. post-treatment (Week 8);changes in scores of abdominal urgencyTimepoint: baseline vs. post-treatment (week 8);proportion of patients in each treatment group who achieve responder status on the adequate relief of bloatingTimepoint: baseline vs. post-treatment (week 8) | — |
Countries
India
Contacts
Public ContactDr Mudgal Kothekar MD
Sun Pharma Advanced Research Company Ltd
Outcome results
None listed