Table 3 Gastrointestinal symptoms, weekly stool frequency, and Bristol Stool Scale scores
Sequencea,b | Level | Baseline | Phase 1 | Washout | Phase 2 | |||
|---|---|---|---|---|---|---|---|---|
Week 0 | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | ||
Bloating | ||||||||
Sequence 1 | 0 | 19 (86.4) | 12 (54.6) | 12 (54.6) | 19 (86.4) | 20 (90.9) | 19 (86.4) | 21 (95.5) |
1 | 2 (9.1) | 6 (27.3) | 7 (31.8) | 3 (13.6) | 2 (9.1) | 3 (13.6) | 1 (4.6) | |
2 | 1 (4.6) | 3 (13.6) | 3 (13.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | |
3 | 0 (0.0) | 1 (4.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | |
Sequence 2 | 0 | 20 (87.0) | 19 (82.6) | 19 (82.6) | 20 (87.0) | 20 (87.0) | 12 (52.2) | 12 (52.2) |
1 | 2 (8.7) | 3 (13.0) | 4 (17.4) | 3 (13.0) | 3 (13.0) | 6 (26.1) | 9 (39.1) | |
2 | 1 (4.4) | 1 (4.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 4 (17.4) | 1 (4.4) | |
3 | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (4.4) | 1 (4.4) | |
Abdominal pain | ||||||||
Sequence 1 | 0 | 19 (86.4) | 17 (77.3) | 15 (68.2) | 18 (81.8) | 20 (90.9) | 19 (86.4) | 20 (90.9) |
1 | 3 (13.6) | 5 (22.7) | 7 (31.8) | 4 (18.2) | 2 (9.1) | 3 (13.6) | 2 (9.1) | |
Sequence 2 | 0 | 21 (91.3) | 22 (95.7) | 21 (91.3) | 21 (91.3) | 21 (91.3) | 17 (73.9) | 18 (78.3) |
1 | 2 (8.7) | 1 (4.4) | 2 (8.7) | 2 (8.7) | 2 (8.7) | 5 (21.7) | 4 (17.4) | |
2 | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (4.4) | 1 (4.4) | |
Flatulence | ||||||||
Sequence 1 | 0 | 19 (86.4) | 15 (68.2) | 15 (68.2) | 20 (90.9) | 21 (95.5) | 21 (95.5) | 21 (95.5) |
1 | 3 (13.6) | 4 (18.2) | 2 (9.1) | 1 (4.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | |
2 | 0 (0.0) | 3 (13.6) | 5 (22.7) | 1 (4.6) | 1 (4.6) | 1 (4.6) | 1 (4.6) | |
Sequence 2 | 0 | 20 (87.0) | 20 (87.0) | 20 (87.0) | 21 (91.3) | 20 (87.0) | 3 (13.0) | 16 (69.6) |
1 | 2 (8.7) | 2 (8.7) | 3 (13.0) | 2 (8.7) | 3 (13.0) | 8 (34.8) | 3 (13.0) | |
2 | 1 (4.4) | 1 (4.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (8.7) | 4 (17.4) | |
Heavy stomach | ||||||||
Sequence 1 | 0 | 1 (4.6) | 1 (4.6) | 2 (9.1) | 2 (9.1) | 2 (9.1) | 6 (27.3) | 6 (27.3) |
1 | 13 (59.1) | 15 (68.2) | 12 (54.6) | 12 (54.6) | 13 (59.1) | 5 (22.7) | 5 (22.7) | |
2 | 8 (36.4) | 6 (27.3) | 8 (36.4) | 8 (36.4) | 7 (31.8) | 11 (50.0) | 11 (50.0) | |
Sequence 2 | 0 | 2 (8.7) | 1 (4.4) | 3 (13.0) | 2 (8.7) | 2 (8.7) | 3 (13.0) | 3 (13.0) |
1 | 13 (56.5) | 15 (65.2) | 13 (56.5) | 14 (60.9) | 14 (60.9) | 13 (56.5) | 12 (52.2) | |
2 | 8 (34.8) | 6 (26.1) | 6 (26.1) | 7 (30.4) | 7 (30.4) | 7 (30.4) | 8 (34.8) | |
3 | 0 (0.0) | 1 (4.4) | 1 (4.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | |
Borborygmus | ||||||||
Sequence 1 | 0 | 15 (68.2) | 8 (36.4) | 10 (45.5) | 15 (68.2) | 14 (63.6) | 15 (68.2) | 13 (59.1) |
1 | 6 (27.3) | 10 (45.5) | 5 (22.7) | 6 (27.3) | 7 (31.8) | 7 (31.8) | 9 (40.96) | |
2 | 1 (4.6) | 4 (18.2) | 6 (27.3) | 1 (4.6) | 1 (4.6) | 0 (0.0) | 0 (0.0) | |
3 | 0 (0.0) | 0 (0.0) | 1 (4.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | |
Sequence 2 | 0 | 16 (69.6) | 15 (65.2) | 16 (69.6) | 14 (60.9) | 16 (69.6) | 6 (26.1) | 8 (34.8) |
1 | 6 (26.1) | 8 (34.8) | 7 (30.4) | 9 (39.1) | 7 (30.4) | 11 (47.8) | 9 (39.1) | |
2 | 1 (4.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 6 (26.1) | 6 (26.1) | |
Weekly stool frequency | ||||||||
Sequence 1 (mean ± SD) | 7.86 ± 1.98 | 10.95 ± 3.54 | 11.05 ± 4.21 | 9.41 ± 2.46 | 7.95 ± 2.30 | 8.32 ± 1.70 | 7.91 ± 1.15 | |
Sequence 2 (mean ± SD) | 7.57 ± 1.95 | 7.91 ± 1.28 | 7.87 ± 1.91 | 7.61 ± 1.73 | 7.83 ± 1.59 | 10.22 ± 4.16 | 10.43 ± 3.46 | |
Bristol Stool Consistency score | ||||||||
Sequence 1 (mean ± SD) | 4.05 ± 0.65 | 4.54 ± 0.77 | 4.42 ± 0.74 | 4.28 ± 0.45 | 4.08 ± 0.46 | 4.07 ± 0.35 | 4.05 ± 0.25 | |
Sequence 2 (mean ± SD) | 4.09 ± 0.67 | 4.12 ± 0.33 | 4.08 ± 0.61 | 4.12 ± 0.54 | 4.07 ± 0.51 | 4.49 ± 0.70 | 4.35 ± 1.11 | |