Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
Severity of Irritable Bowel Syndrome-IBS (Reduction of the severity of IBS measured by the Bowel Syndrome Severity Score-IBSSS (Francis) at the end of treatment in each stage respect to baseline value of each one). Measurement time: At baseline, weeks 2, 4, 12 (stage 1 y stage 2) and, week 26 (follow-up at the end of second stage).
Key secondary outcomes:
Related to efficacy:
1. Intensity of pain (Change of the value of this item in the IBSSS (Francis) questionnaire at the end of treatment in each stage respect to baseline value of each one). Measurement time: At baseline, weeks 2, 4, 12 (stage 1 y stage 2) and, week 26 (follow-up at the end of second stage).
2. Intensity of abdominal distension (Change of the value of this item in the IBSSS (Francis) questionnaire at the end of treatment in each stage respect to baseline value of each one). Measurement time: At baseline, weeks 2, 4, 12 (stage 1 y stage 2) and, week 26 (follow-up at the end of second stage).
3. Changes in bowel habit (Change of the value of this item in the IBSSS (Francis) questionnaire at the end of treatment in each stage respect to baseline value of each one). Measurement time: At baseline, weeks 2, 4, 12 (stage 1 y stage 2) and, week 26 (follow-up at the end of second stage).
4. Quality of Life (IBS-QOL questionnaire). Measurement time: At baseline and, week 12 (in each stage)
Note: The baseline value of the stage 2 is recorded in the second week of this stage. This week corresponds with the week 14 if both stage are considered in a same timeline.
Related to safety:
5. Adverse events-AE (Reported by the patient and by laboratory tests measured as: Occurrence of an AE (Yes, No); Description of the AE (Name of the adverse event); Duration of the AE (Difference between start and finish of AE); Intensity of the AE (Mild, Moderate, Severe, AE that threatens or incapacitates and AE that causes death); Severity of the AE (Serious/serious, Not serious/not serious); Treatment under study (No changes, Dose modification, Temporary interruption, Definitive interruption of treatment under study); AE result (Recovered, Improved, Persists, Squeals); Causal relationship (1. Definitive 2. Very Likely, 3. Likely, 4. Possible, 5. Unrelated 6. Unknown)). Measurement time: At baseline, weeks 2, 4, 12 (stage 1 y stage 2) and, week 26 (follow-up at the end of second stage).