Table 2.
Distribution of participants in the study groups according to the CONSORT diagram, and demographic characteristics of the three groups with the intention to treat.
| Group 1 36 women 5 men |
Group 2 50 women 1 man |
Group 3 39 women 1 man |
1 × 2 | 1 × 3 | 2 × 3 | 1 × 2 × 3 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Parameter | Average ± σ | n | P value¹ | Average ±σ | n | P value² | Average ±σ | n | P value³ | P value4 | P value5 | P value6 | P value7 |
| Weekly number of evacuations | |||||||||||||
| Week 0 | 1.9 ± 0.8 | 41 | 1.8 ± 0.8 | 51 | 1.7 ± 0.8 | 40 | .481 | .149 | .413 | .353 | |||
| Week 1 | 4.9 ± 2.5 | 41 | <.001 | 4.7 ± 2.0 | 51 | <.001 | 6.4 ± 7.7 | 40 | <.001 | .818 | .224 | .141 | .187 |
| Week 2 | 5.8 ± 2.7 | 41 | <.001 | 5.1 ± 2.0 | 50 | <.001 | 5.9 ± 2.9 | 39 | <.001 | .119 | .946 | .118 | .217 |
| Week 3 | 5.5 ± 2.6 | 41 | <.001 | 5.0 ± 1.8 | 49 | <.001 | 6.1 ± 2.4 | 39 | <.001 | .262 | .278 | .011 | .066 |
| Week 4 | 5.2 ± 1.8 | 41 | <.001 | 5.1 ± 2.0 | 49 | <.001 | 5.5 ± 2.3 | 39 | <.001 | .766 | .645 | .465 | .744 |
| Stool quality according to the Bristol Scale* | |||||||||||||
| Week 0 | 1.9 ± 0.8 | 41 | 1.8 ± 0.8 | 51 | 1.7 ± 0.8 | 40 | .481 | .149 | .413 | .353 | |||
| Week 1 | 3.0 ± 1.2 | 41 | <.001 | 2.9 ± 1.1 | 51 | <.001 | 2.7 ± 0.9 | 40 | .004 | .739 | .253 | .366 | .499 |
| Week 2 | 3.2 ± 1.1 | 41 | <.001 | 2.9 ± 1.1 | 50 | <.001 | 3.2 ± 0.9 | 39 | <.001 | .291 | .928 | .294 | .449 |
| Week 3 | 3.1 ± 1.1 | 41 | <.001 | 3.4 ± 1.1 | 49 | <.001 | 3.4 ± 1.1 | 39 | <.001 | .219 | .250 | .966 | .395 |
| Week 4 | 3.6 ± 1.1 | 41 | <.001 | 3.3 ± 0.9 | 49 | <.001 | 3.3 ± 1.0 | 39 | <.001 | .278 | .310 | .974 | .469 |
1: P value of the two-tailed paired t student test to identify differences between weeks 1, 2, 3, 4 with week 0 in group 1.
2: P value of the two-tailed paired t student test to identify differences between weeks 1, 2, 3, 4 with week 0 in group 2.
3: P value of the two-tailed paired t student test to identify differences between weeks 1, 2, 3, 4 with week 0 in group 3.
4: P value of the two-tailed paired t student test to identify the differences between groups 1 and 2 at weeks 0, 1, 2, 3, 4.
5: P value of the two-tailed paired t student test to identify the differences between groups 1 and 3 at weeks 0, 1, 2, 3, 4.
6: P value of the two-tailed paired t student test to identify the differences between groups 2 and 3 at weeks 0, 1, 2, 3, 4.
7: P value of the analysis of variance to identify the differences between groups 1, 2, and 3 in weeks 0, 1, 2, 3, 4.
Group 1 = formula with 3 billion CFU/sachet, Group 2 = formula with 8 billion CFU/sachet, Group 3 = conventional fiber treatment, CFU = colony-forming units.
Stool quality according to the Bristol Scale according to Lewis and Heaton (1997).