Severity of gastrointestinal symptoms (during the last 2 weeks) (n = 40) | 0 = no, 4 = max, Median, range | Percentage of patients that reported no symptoms, scoring ‘0’ (%) | |||
| Baseline | End of study | Baseline | End of study | p-value |
Diarrhoea | 0 (0 - 3) | 0 (0 - 2) | 67.5% | 75% | p = 0.62 |
Constipation | 1 (0 - 3) | 0 (0 - 3) | 37.5% | 52.5% | p = 0.26 |
Feeling of incomplete evacuation | 1 (0 - 4) | 0 (0 - 3) | 42.5% | 57.5% | p = 0.26 |
Straining to evacuate | 0 (0 - 4) | 0 (0 - 2) | 50% | 65% | p = 0.26 |
Bloating | 3 (0 - 4) | 1 (0 - 3) | 10% | 20% | p = 0.35 |
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Frequency of gastrointestinal symptoms (during the last 2 weeks) (n = 40) | 0 = never, 4 = always, Median, range | Percentage of patients that reported never having symptoms, scoring “0” (%) | |||
| Baseline | End of study | Baseline | End of study | p-value |
Epigastric pain | 1 (0 - 3) | 1 (0 - 2) | 17.5% | 45% | p = 0.02*; |
Epigastric fullness | 2 (0 - 3) | 1 (0 - 2) | 17.5% | 42.5% | p = 0.03*; |
Belching | 2 (0 - 3) | 1 (0 - 3) | 7.5% | 15% | p = 0.48 |
Flatulence | 2 (0 - 3) | 1 (0 - 3) | 2.5% | 22.5% | p = 0.02*; |
Frequent bowel movements | 0 (0 - 3) | 0 (0 - 3) | 67% | 75% | p = 0.62 |
Diarrhoea | 0 (0 - 2) | 0 (0 - 2) | 72.% | 72% |
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Combined Endpoint of all gastrointestinal symptoms (Frequency and severity) (n = 37) | 0 = min, 40 = max, Median, range
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| Baseline | End of study |
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| p-value |
Combined gastrointestinal symptoms | 10 (4 - 21) | 6 (0 - 15) |
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| p ≤ 0.05* |
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Quality of Life (n = 40) | 0 = min, 10 = max, Median, range |
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| Baseline | End of study |
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General wellness | 7 (3 - 10) | 8 (4 - 10) |
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State of health | 9 (3 - 10) | 9 (3 - 10) |
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State of energy | 7 (2 - 10) | 8 (2 - 10) |
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