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

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%

Combined Endpoint of all gastrointestinal symptoms (Frequency and severity) (n = 37)

0 = min, 40 = max, Median, range

Baseline

End of study

p-value

Combined gastrointestinal symptoms

10 (4 - 21)

6 (0 - 15)

p ≤ 0.05*

Quality of Life (n = 40)

0 = min, 10 = max, Median, range

Baseline

End of study

General wellness

7 (3 - 10)

8 (4 - 10)

State of health

9 (3 - 10)

9 (3 - 10)

State of energy

7 (2 - 10)

8 (2 - 10)