Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Severity of IBS symptoms by IBS-SSS |
Irritable bowel syndrome severity scoring system (IBS-SSS); 5-item questionnaire; scale from 0% (= not at all) to 100% (= very severe); cut-off of IBS-SSS scores to evaluate the severity of IBS: < 175 for mild IBS, 175-300 for moderate IBS, and > 300 for severe IBS |
week 0 |
|
Primary |
Severity of IBS symptoms by IBS-SSS |
Irritable bowel syndrome severity scoring system (IBS-SSS); 5-item questionnaire; scale from 0% (= not at all) to 100% (= very severe); cut-off of IBS-SSS scores to evaluate the severity of IBS: < 175 for mild IBS, 175-300 for moderate IBS, and > 300 for severe IBS |
week 12 |
|
Primary |
Severity of IBS symptoms by IBS-SSS |
Irritable bowel syndrome severity scoring system (IBS-SSS); 5-item questionnaire; scale from 0% (= not at all) to 100% (= very severe); cut-off of IBS-SSS scores to evaluate the severity of IBS: < 175 for mild IBS, 175-300 for moderate IBS, and > 300 for severe IBS |
week 36 |
|
Primary |
overall change in health status |
Rating scale from 1 (= much worse) to 5 (= much better) |
week 12 |
|
Primary |
overall change in health status |
Rating scale from 1 (= much worse) to 5 (= much better) |
week 36 |
|
Secondary |
Disease related Quality of Life by IBS-QOL |
The IBS-QOL is a self-report quality-of-life measure specific to Irritable Bowel Syndrome (IBS) that can be used to assess the impact of IBS and its treatment. 34 items with a 5-point response scale from 1 (=not at all) to 5 (= Extremely/a great deal); 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life. |
week 0 |
|
Secondary |
Disease related Quality of Life by IBS-QOL |
The IBS-QOL is a self-report quality-of-life measure specific to Irritable Bowel Syndrome (IBS) that can be used to assess the impact of IBS and its treatment. 34 items with a 5-point response scale from 1 (=not at all) to 5 (= Extremely/a great deal); 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life. |
week 12 |
|
Secondary |
Disease related Quality of Life by IBS-QOL |
The IBS-QOL is a self-report quality-of-life measure specific to Irritable Bowel Syndrome (IBS) that can be used to assess the impact of IBS and its treatment. 34 items with a 5-point response scale from 1 (=not at all) to 5 (= Extremely/a great deal); 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life. |
week 36 |
|
Secondary |
General Quality of Life by EQ-5D-SL |
The EQ-5D assesses health status in terms of five dimensions of health (mobility, self-care, usual activities, pain and discomfort, and anxiety and depression) and is considered a 'generic' questionnaire because these dimensions are not specific to any one patient group or health condition. 5-point response-scale from 1 (=not /no problems) to 5 (=unable to [mobility, self-care, usual activities]/extreme [pain/depression]/extremely [anxiety/depression]); result: 5-digit health status profile that represents that person's level of reported problems on the five EQ-5D health dimensions |
week 0 |
|
Secondary |
General Quality of Life by EQ-5D-SL |
The EQ-5D assesses health status in terms of five dimensions of health (mobility, self-care, usual activities, pain and discomfort, and anxiety and depression) and is considered a 'generic' questionnaire because these dimensions are not specific to any one patient group or health condition. 5-point response-scale from 1 (=not /no problems) to 5 (=unable to [mobility, self-care, usual activities]/extreme [pain/depression]/extremely [anxiety/depression]); result: 5-digit health status profile that represents that person's level of reported problems on the five EQ-5D health dimensions |
week 12 |
|
Secondary |
General Quality of Life by EQ-5D-SL |
The EQ-5D assesses health status in terms of five dimensions of health (mobility, self-care, usual activities, pain and discomfort, and anxiety and depression) and is considered a 'generic' questionnaire because these dimensions are not specific to any one patient group or health condition. 5-point response-scale from 1 (=not /no problems) to 5 (=unable to [mobility, self-care, usual activities]/extreme [pain/depression]/extremely [anxiety/depression]); result: 5-digit health status profile that represents that person's level of reported problems on the five EQ-5D health dimensions |
week 36 |
|
Secondary |
Stress: Perceived Stress (PSS-10) |
Perceived Stress Scale (PSS), Rating on a five-step scale from 1 (= never) to 5 (=very often), high stress is assumed from a total score of 20 points |
week 0 |
|
Secondary |
Stress: Perceived Stress (PSS-10) |
Perceived Stress Scale (PSS), Rating on a five-step scale from 1 (= never) to 5 (=very often), high stress is assumed from a total score of 20 points |
week 12 |
|
Secondary |
Stress: Perceived Stress (PSS-10) |
Perceived Stress Scale (PSS), Rating on a five-step scale from 1 (= never) to 5 (=very often), high stress is assumed from a total score of 20 points |
week 36 |
|
Secondary |
Stress: Coping Strategies (CISS) |
Short version of the Coping Inventory for Stressful Situations (24 items); Rating on a five-step scale from 1 (= not at all) to 5 (= very much); sum score for each coping strategy; higher scores indicate a greater use of that particular coping strategy |
week 0 |
|
Secondary |
Stress: Coping Strategies (CISS) |
Short version of the Coping Inventory for Stressful Situations (24 items); Rating on a five-step scale from 1 (= not at all) to 5 (= very much); sum score for each coping strategy; higher scores indicate a greater use of that particular coping strategy |
week 12 |
|
Secondary |
Stress: Coping Strategies (CISS) |
Short version of the Coping Inventory for Stressful Situations (24 items); Rating on a five-step scale from 1 (= not at all) to 5 (= very much); sum score for each coping strategy; higher scores indicate a greater use of that particular coping strategy |
week 36 |
|
Secondary |
Core Self-Evaluation by CSES |
Core Self-Evaluation (CSES), 12 items on five-point Likert scale, 1 indicates disagreement and 5 indicates full agreement. High scores on the CSES represents a positive, confident, and self-efficacious person |
week 0 |
|
Secondary |
Core Self-Evaluation by CSES |
Core Self-Evaluation (CSES), 12 items on five-point Likert scale, 1 indicates disagreement and 5 indicates full agreement. High scores on the CSES represents a positive, confident, and self-efficacious person |
week 12 |
|
Secondary |
Core Self-Evaluation by CSES |
Core Self-Evaluation (CSES), 12 items on five-point Likert scale, 1 indicates disagreement and 5 indicates full agreement. High scores on the CSES represents a positive, confident, and self-efficacious person |
week 36 |
|
Secondary |
Utilization of medical services |
Number of visits |
week 0 |
|
Secondary |
Utilization of medical services |
Number of visits |
week 12 |
|
Secondary |
Utilization of medical services |
Number of visits |
week 36 |
|
Secondary |
Days of work disability |
Number of days |
week 0 |
|
Secondary |
Days of work disability |
Number of days |
week 12 |
|
Secondary |
Days of work disability |
Number of days |
week 36 |
|
Secondary |
Anxiety and depression by HADS |
Hospital Anxiety and Depression Scale (HADS), 14 items (7 each for depressive symptoms or symptoms of anxiety). The two summated scores of the summated scales HADS-A and HADS-D range between 0 and 21. high scores indicate depressivness and anxiety. |
week 0 |
|
Secondary |
Anxiety and depression by HADS |
Hospital Anxiety and Depression Scale (HADS), 14 items (7 each for depressive symptoms or symptoms of anxiety). The two summated scores of the summated scales HADS-A and HADS-D range between 0 and 21. high scores indicate depressivness and anxiety. |
week 12 |
|
Secondary |
Anxiety and depression by HADS |
Hospital Anxiety and Depression Scale (HADS), 14 items (7 each for depressive symptoms or symptoms of anxiety). The two summated scores of the summated scales HADS-A and HADS-D range between 0 and 21. high scores indicate depressivness and anxiety. |
week 36 |
|
Secondary |
Qualitative Interviews |
Qualitative interviews for gaining further insights into patients experiences |
week 12 |
|
Secondary |
Adverse events |
all adverse events |
week 12 |
|
Secondary |
Adverse events |
all adverse events |
week 36 |
|