Table 1:
Summary statistics of baseline Barr diary and Fecal Calprotectin by treatment group. The adjusted geometric means and 95% confidence interval of Barr diary data and FC data at follow-up visits are shown after controlling for age and each individual baseline values. *
| Barry diary Visit 2 (Baseline) | Median (interquartile range) | ||||
|---|---|---|---|---|---|
| L. reuteri N=13 | Placebo N=7 | p value | |||
| Crying+fussing time (mins) | 275 (267, 368) | 283.5 (255, 612) | 0.66 | ||
| Crying time (mins) | 109.5 (70, 185) | 96.0 (38, 140) | 0.43 | ||
| Fussing time (mins) | 170.0 (147, 217) | 231.0 (187, 502) | 0.09 | ||
| Barr Diary Follow-up visits | Adjusted means (95% Confidence Intervals) | ||||
| L. reuteri | Placebo | p value | |||
| Crying+fussing time (mins) | |||||
| Visit 3 (Day 21) | 99 (42, 234) | 164 (110, 246) | 0.31 | ||
| Visit 4 (Day 42) | 94 (61, 144) | 29 (5, 162) | 0.19 | ||
| Visit 5 (Day 92) | 36 (17, 78) | 35 (14, 88) | 0.96 | ||
| Crying time (mins) | |||||
| Visit 3 (Day 21) | 19 (6, 56) | 17 (3, 81) | 0.92 | ||
| Visit 4 (Day 42) | 14 (5, 34) | 11 (2, 52) | 0.86 | ||
| Visit 5 (Day 92) | 3 (1, 7) | 5 (1, 22) | 0.55 | ||
| Fussing time (mins) | |||||
| Visit 3 (Day 21) | 68 (28, 164) | 111 (70, 177) | 0.38 | ||
| Visit 4 (Day 42) | 58 (34, 100) | 20 (5, 76) | 0.15 | ||
| Visit 5 (Day 92) | 31 (14, 72) | 22 (10, 49) | 0.56 | ||
| Fecal calprotectin (μg/g) | Median (interquartile range) | ||||
| Visit 1 (Baseline) | 216 (132, 266) | 148 (82, 192) | 0.19 | ||
| Follow-up visits | Adjusted means (95% Confidence Intervals) | ||||
| Visit 4 (Day 42) | 140 (78, 251) | 103 (62, 172) | 0.50 | ||
| Visit 5 (Day 92) | 75 (48, 118) | 94 (58, 150) | 0.57 | ||
p-values for baseline data are obtained by Wilcoxon rank sum test. For follow-up visits, longitudinal models were used as follows. Longitudinal model: (1). In(barr diary)=β0+ β1*visit3 + β2*group+ β3*visit3*group + β4*visit4 + β5*group+ β6*visit4*group + β7*(Age at baseline) + β8*(barr diary at baseline); Here, visit3and visit4 are dummy variables; visit3=1 if at visit 3, 0 otherwise; visit4=1 if at visit 4, 0 otherwise; group=1 if in LR group, 0 otherwise; (2). In(fecal calprotectin)=β0+ β1*visit4 + β2*group+ β3*visit4*group + β4*(Age at baseline) + β5*(fecal calprotectin at baseline); Here, visit4 is dummy variable; visit4=1 if at visit 4, 0 otherwise; group=1 if in LR group, 0 otherwise.