Comparing Lactobacillus plantarum 299v with Placebo in treating irritable bowel syndrome patients
Not Applicable
- Conditions
- irritable bowel syndrome.Irritable bowel syndrome
- Registration Number
- IRCT20200504047303N1
- Lead Sponsor
- Genetics Pharma PVT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 190
Inclusion Criteria
Fulfilling the Rome III criteria for IBS
Willing to participate
Committed for follow up throughout the study period
Exclusion Criteria
History of major abdominal surgery,
Organic intestinal disease or chronic infectious disease like HIV or tuberculosis
Pregnant and the female breastfeeding their babies
Anyone with current use of antibiotics
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Symptomatic treatment with out Lactobacillus plantarum 299v. Timepoint: conducted for six (6) months. Method of measurement: Daily frequency of abdominal pain was considered as primary end point. The secondary end points were improvement in the severity of abdominal pain, severity of the bloating and feeling of partial rectal emptying. Both the primary and the secondary end points were gauged on the visual analogue scale from zero (0) to ten (10), 0 being normal and 10 being very severe. In each visit the patients were examined thoroughly and all the parameters were noted along with the medication compliance.
- Secondary Outcome Measures
Name Time Method