Table 7. Mean number of bowel movements per day, subjective ratings of bowel habit satisfaction, composite scores of IBS symptom relief and global assessments of IBS symptom relief with B. infantis 35624 or placebo in subjects with IBS. Post-baseline means are least squares means from the statistical mixed model.
| Parameter | Study Visit | Treatment Groups | |||
|---|---|---|---|---|---|
| |
|
B. infantis 35624 (log 10 ng DNA g−1) |
Placebo (log 10 ng DNA g−1) |
|
|
| |
|
Mean (SE) |
Mean (SE) |
Difference (SE) |
p-value |
| Number of daily bowel movements 1 |
Baseline |
1.66 (0.155) |
1.74 (0.159) |
|
|
| |
Week 4 |
1.69 (0.085) |
1.46 (0.088) |
0.23 (0.123) |
0.059 |
| |
Week 8 |
1.91 (0.222) |
1.58 (0.234) |
0.34 (0.323) |
0.297 |
| Overall appearance of bowel movements 2 |
Baseline |
3.58 (0.189) |
3.62 (0.194) |
|
|
| |
Week 4 |
3.66 (0.156) |
3.51 (0.161) |
0.14 (0.225) |
0.524 |
| |
Week 8 |
3.93 (0.187) |
3.45 (0.201) |
0.48 (0.274) |
0.080 |
| Bowel habit satisfaction score 3 |
Baseline |
2.72 (0.162) |
3.00 (0.167) |
|
|
| |
Week 4 |
2.66 (0.197) |
2.41 (0.209) |
0.25 (0.287) |
0.381 |
| |
Week 8 |
2.36 (0.188) |
2.21 (0.199) |
0.15 (0.275) |
0.575 |
| IBS composite score 4 |
Baseline |
7.57 (0.431) |
7.92 (0.443) |
|
|
| |
Week 4 |
6.98 (0.501) |
6.38 (0.533) |
0.60 (0.731) |
0.410 |
| Week 8 | 6.39 (0.468) | 5.80 (0.495) | 0.59 (0.682) | 0.385 | |
(1) The number of bowel movements was recorded daily during weeks 4 and 8 of treatment. (2) Appearance of bowel movements was scored on a seven-point Bristol Stool Form Scale, as follows: 1, separate hard lumps, like nuts (difficult to pass); 2, sausage-shaped but lumpy; 3, sausage- or snake-like, cracked surface; 4, sausage- or snake-like, smooth surface; 5, soft blobs with clear cut edges (passed easily); 6, fluffy pieces with ragged edges, a mushy stool; 7, watery stool, entirely liquid. (3) Bowel habit satisfaction was scored at the end of weeks 4 and 8. Scoring scale: 0, very satisfied; 1, satisfied; 2, somewhat satisfied; 3, somewhat dissatisfied; 4, dissatisfied; 5, very dissatisfied. (4) IBS composite score derived from the sum of scores for abdominal pain, bloating and bowel habit satisfaction.