Irritable Bowel Syndrome
Conditions
Brief summary
1. Response rate measured by Bristol Stool Scale. BSS response is defined as at least 50% reduction in the number of days with at least one stool that has a consistency of 6 or 7 per week compared to baseline for a minimum of 13 of the 26 measurements (i.e. at least 50% improvement of stool consistency during treatment) and 2. Response rate measured by the 11-point numeric rating scale (NRS). Abdominal Pain Intensity response is defined as a decrease in the weekly average of worst abdominal pain
Detailed description
Response rate measured by the 7-point IBS Global Assessment of Improvement Scale (IBS-GAI) during the 26 weeks of treatment. IBS-GAI response is defined as at least 50% moderate or substantial improvement during the 26 weeks of treatment • Response rate measured by the 11-point numeric rating scale during the 26 weeks of treatment. Response is defined as ≥30% improvement in Abdominal Pain Intensity weekly response compared to baseline for a minimum of 20 of the 26 measurements (i.e. 75% improvem
Interventions
DRUGPlacebo suspension is identical to Symbioflor®2 liquid formulation in appearance
DRUGweight and composition
DRUGwith the exception that the active ingredient will be omitted. Placebo constitutes are sodium chloride
DRUGmagnesium sulphate 7H2O
DRUGpotassium chloride
DRUGcalcium chloride 2H2O
DRUGmagnesium chloride 6H2O
DRUGand purified water
DRUGSymbioflor 2 Tropfen zum Einnehmen
DRUGSuspension
Sponsors
SymbioPharm GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Response rate measured by Bristol Stool Scale. BSS response is defined as at least 50% reduction in the number of days with at least one stool that has a consistency of 6 or 7 per week compared to baseline for a minimum of 13 of the 26 measurements (i.e. at least 50% improvement of stool consistency during treatment) and 2. Response rate measured by the 11-point numeric rating scale (NRS). Abdominal Pain Intensity response is defined as a decrease in the weekly average of worst abdominal pain | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate measured by the 7-point IBS Global Assessment of Improvement Scale (IBS-GAI) during the 26 weeks of treatment. IBS-GAI response is defined as at least 50% moderate or substantial improvement during the 26 weeks of treatment • Response rate measured by the 11-point numeric rating scale during the 26 weeks of treatment. Response is defined as ≥30% improvement in Abdominal Pain Intensity weekly response compared to baseline for a minimum of 20 of the 26 measurements (i.e. 75% improvem | — |
Countries
Germany
Outcome results
None listed