Table 3.
Outcomes at 1 and 6 months in treatment and placebo groups
| Outcomes | Mean (SD) | Adjusted mean difference* (95% CI) | P value | Median (interquartile range) | P value† | ||||
|---|---|---|---|---|---|---|---|---|---|
| No | Probiotic | No | Placebo | Probiotic | Placebo | ||||
| 1 month: | |||||||||
| Total daily cry or fuss time (min/day) | 67 | 229 (137) | 60 | 191 (103) | 49 (8 to 90) | 0.02 | 203 (130-295) | 166 (128-265) | 0.14 |
| Fuss time (min/day) | 67 | 153 (109) | 60 | 112 (78) | 52 (19 to 84) | 0.002 | 125 (75-210) | 106 (51-150) | 0.04 |
| Cry time (min/day) | 67 | 76 (82) | 60 | 79 (77) | −2 (−28 to 24) | 0.86 | 56 (13-105) | 63 (30-100) | 0.4 |
| Daily cry or fuss episodes | 67 | 7.5 (4.7) | 59 | 8.1 (4.9) | 0.4 (−1.1 to 1.8) | 0.62 | 7 (4-11) | 7 (5-12) | 0.52 |
| Infant sleep duration (min/day) | 67 | 800 (141) | 60 | 842 (119) | −47 (−90 to −3) | 0.04 | 818 (718-903) | 857 (772-921) | 0.08 |
| Maternal mental health (EPDS score) | 79 | 8.2 (4.7) | 75 | 7.9 (4.9) | 0.6 (−0.7 to 1.9) | 0.36 | 8 (4-12) | 8 (4-11) | 0.63 |
| Family functioning (PedsQL score) | 79 | 69.8 (21.6) | 75 | 71.1 (20.8) | −0.7 (−6.1 to 4.7) | 0.80 | 70 (56-85) | 75 (60-85) | 0.70 |
| Parent quality adjusted life years (AQoL score) | 79 | 0.7 (0.2) | 74 | 0.8 (0.2) | 0.0 (−0.1 to 0.0) | 0.11 | 0.7 (0.6-0.9) | 0.8 (0.7-0.9) | 0.19 |
| Infant faecal microbial diversity score | 28 | 32.8 (1.4) | 27 | 30.4 (1.0) | −2.5‡ (−5.9 to 1.0) | 0.16 | 31 (28-37) | 31 (27-35) | 0.34 |
| Infant faecal Escherichia coli colonisation (cfu/mL) | 31 | 3.1 (5.3)×107 | 34 | 2.6 (5.1)×107 | −0.5‡ (−3.1 to 2.1×107) | 0.70 | 0.8 (0.9-3.0)×107 | 0.5 (0.0-2.4)×107 | 0.31 |
| Infant faecal calprotectin (mg/kg) | 53 | 230.0 (36.5) | 49 | 197.4 (28.9) | −32.6‡ (−125.9 to 60.7) | 0.49 | 135 (74-259) | 114 (73-242) | 0.63 |
| 6 months: | |||||||||
| Total daily cry or fuss time (min/day) | 65 | 122 (118) | 58 | 131 (111) | −7 (−47 to 34) | 0.75 | 85 (55-140) | 105 (60-160) | 0.27 |
| Fuss time (min/day) | 65 | 84 (77) | 58 | 84 (83) | 0 (−29 to 29) | 0.99 | 63 (30-100) | 61 (35-105) | 0.94 |
| Cry time (min/day) | 65 | 38 (56) | 58 | 47 (52) | −7 (−27 to 13) | 0.49 | 18 (0-45) | 29 (10-75) | 0.13 |
| Daily cry or fuss episodes | 65 | 5.8 (5.0) | 58 | 6.6 (4.4) | −0.1 (−1.8 to 1.5) | 0.87 | 4 (3-8) | 6 (3-9) | 0.08 |
| Infant sleep duration (min/day) | 65 | 776 (185) | 58 | 783 (167) | 1 (−66 to 68) | 0.97 | 810 (720-880) | 807 (730-870) | 0.98 |
| Maternal mental health (EPDS score) | 69 | 6.5 (4.5) | 63 | 7.1 (4.7) | −0.1 (−1.6 to 1.3) | 0.84 | 6 (3-9) | 6 (3-11) | 0.44 |
| Family functioning (PedsQL score) | 69 | 78.4 (19.4) | 63 | 76.0 (21.7) | 1.0 (−5.5 to 7.6) | 0.76 | 80 (70-95) | 80 (60-100) | 0.70 |
| Infant functioning (PedsQL score) | 69 | 77.7 (11.4) | 63 | 76.3 (11.1) | 0.9§ (−3.1 to 4.8) | 0.66 | 78 (72-84) | 75 (69-84) | 0.32 |
| Parent quality adjusted life years (AQoL score) | 69 | 0.8 (0.2) | 63 | 0.8 (0.2) | −0.1 (−0.1 to 0.0) | 0.07 | 0.8 (0.7-0.9) | 0.8 (0.7-1.0) | 0.22 |
cfu=colony forming units; EPDS=Edinburgh postnatal depression scale; PedsQL=paediatric quality of life inventory; AQoL=assessment of quality of life.
*Adjusted for sex, age, delivery mode, feeding type, family history of atopy, and respective baseline variable.
†Two sample Wilcoxon rank sum test.
‡Unadjusted analyses of available faecal samples.
§Adjusted for sex, age, delivery mode, feeding type, and family history of atopy.