A multicentre Phase 2, randomised, double blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of repeated oral doses of Blautix™ in adult subjects with irritable bowel syndrome (IBS), subtypes IBS-C and IBS-D.
This is a randomised, placebo-controlled, parallel group, repeat dose multicentre study in adult male and female subjects of 18 to 70 years of age with a confirmed diagnosis of either IBS- C or IBS-D.
An 8-week treatment period of Blautix™ or placebo is considered sufficient to assess any changes in the subject assessment of IBS symptoms and the analysis of pharmacodynamic changes on the microbiota. Subject assessment of symptoms by use of rating scales/scores and a quality of life questionnaire are considered appropriate.
Criteria:-Males and Females between 18 and 70 years of age
-Body Mass Index (BMI): 18-39 kg/m2
IBS-C
Abdominal Pain Intensity: weekly average of worst daily (in past 24 hours) abdominal pain score of > 3.0 on a 0 to 10-point scale
And
- Stool Frequency: more than 25% of bowel movements with a consistency of Type 1 or Type 2 Bristol stool chart and less than 25% of bowel movements with Bristol stool form Type 6 or Type 7. Subject must have fewer than 3 CSBMs1 within a one week period (7 days)
IBS-D
Abdominal Pain Intensity: weekly average of worst daily (in past 24 hours) abdominal pain score of > 3.0 on a 0 to 10-point scale
And
- Stool Consistency: more than 25% of bowel movements with a consistency of Type 6 or Type 7 Bristol stool chart and less than 25% of bowel movements with Bristol stool form Type 1 or Type 2. Subjects must have at least one Type 6 or Type 7 bowel movements on at least four days within a one week period (7 days).