Health Condition 1: K580- Irritable bowel syndrome with diarrhea Health Condition 2: K582- Mixed irritable bowel syndrome
Conditions
Interventions
Intervention1: Providac: Lactobacillus acidophilus LA-5® and Bifidobacterium BB-12®in dosage of total 1 billion CFU per capsule, administered orally twice daily for 12 weeks given concomitantly wi
Sponsors
Zydus Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects in the age group of 18-65 years (both ages inclusive) with a positive diagnoses of non-constipated IBS ) diagnosed based on responses to the Enhanced Asian ROME 3 Questionnaire 2. Criteria fulfilled for the last 3 months with symptom onset at least 6 months before study. 3. Able to provide signed informed consent and be able to comply with study procedures
Exclusion criteria
Exclusion criteria: 1.Subjects with Constipation Predominant IBS (IBS-C) 2.Subjects with history of major abdominal surgery, a history of inflammatory bowel disease or diverticular disease, celiac disease, structural abnormalities of the gastrointestinal tract other than oesophagitis or gastritis allergic diseases. 3.Other organic or major psychiatric disorders such as schizophrenia manic depressive conditions as assessed by medical history, appropriate consultations and laboratory tests. 4.Faecal occult blood test positive 5.Pregnant or Lactating mothers 6.Any other medical condition in the opinion of the investigator rendering the subject ineligible to participate. 7.Use of antibiotics or probiotics in the three weeks preceding study start.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the effectiveness of 12 weeks consumption of Lactobacillus acidophilus, LA-5® and Bifidobacterium animalis ssp. lactis, BB-12® on the abnormal defecation and abdominal pain and discomfort in non-constipated IBS patients.Timepoint: â?¢ Number and proportion of responders in each arm who experience improvement in symptoms recorded by IBS Global Improvement Scale (IBS-GIS): â?¢ A responder defined as a patient who answered that their symptoms were either â??moderately improvedâ?? or â??substantially improvedâ??. The weekly numerical evaluation of abdominal pain from baseline to treatment end of 12 weeks as defined in the daily symptom diary | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the effects of 12 weeks consumption of Lactobacillus acidophilus, LA-5® and Bifidobacterium animalis ssp. lactis, BB-12® on health-related quality of life using the questionnaires IBS-QoL EAR3Q and IBS-SSS.Timepoint: Numerical evaluation of changes in scales from baseline to treatment end of 12 weeks. The number of pain free days from baseline to treatment end of 12 weeks ï?· The weekly numerical evaluation of abdominal discomfort, straining and bloating from baseline to treatment end of 12 weeks ï?· The difference in scores of urgency of defecation from baseline to end of 12 weeks ï?· Percentage reduction of 50% and above in abdominal pain scores from baseline to end of 12 weeks. | — |
Countries
India
Contacts
Public ContactAshok Jaiswal
ZYDUS HEALTHCARE LIMITED
Outcome results
None listed