Secondary outcomes according to intervention group
| Variable | Probiotic arm | Placebo arm | OR (95% CI) | p Value* |
|---|---|---|---|---|
| SPT† positive at 6 m | 6/151 (3.97%) | 16/147 (10.88%) | 0.34 (0.13 to 0.89) | 0.023 |
| ▸ cow’s milk | 0/148 (0.0%) | 5/147 (3.40%) | – | 0.030* |
| ▸ egg | 5/148 (3.4%) | 14/147 (9.5%) | 0.33 (0.11 to 0.95) | 0.032 |
| ▸ house dust mite | 1/151 (0.66%) | 0/147 (0.0%) | – | 0.51* |
| ▸ cat | 0/151 (0.0%) | 2/145 (1.4%) | – | 0.24* |
| ▸ grass | 1/150 (0.67%) | 0/147 (0.0%) | – | 0.49* |
| SPT† positive at either 6 m or 2 yrs | 18/171 (10.5%) | 32/173 (18.5%) | 0.52 (0.28 to 0.98) | 0.036 |
| ▸ cow’s milk | 1/171 (0.6%) | 6/173 (3.5%) | 0.16 (0.02 to 1.4) | 0.12* |
| ▸ egg | 9/171 (5.3%) | 19/173 (11.0%) | 0.45 (0.2 to 1.0) | 0.052 |
| ▸ house dust mite | 9/171 (5.3%) | 11/173 (6.4%) | 0.82 (0.3 to 2.0) | 0.66 |
| ▸ cat | 3/171 (1.8%) | 7/173 (4.0%) | 0.42 (0.1 to 1.7) | 0.20 |
| ▸ grass | 2/171 (1.2%) | 2/173 (1.2%) | 1.0 (0.14 to 7.2) | 0.99* |
| Skin | ||||
| ▸ Atopic eczema at 6 m | 4/151 (2.7%) | 13/147 (8.8%) | 0.28 (0.089 to 0.88) | 0.021 |
| ▸ Severity of eczema at 6 m clinic‡; median, (IQR) | 14.3 (7.5–17.9) | 14.4 (10.6–24.9) | – | 0.46 |
| ▸ Atopic eczema at 2 yrs | 9/171 (5.3%) | 21/173 (12.1%) | 0.40 (0.18 to 0.91) | 0.024 |
| ▸ Severity of eczema at 2 yr clinic‡; median (IQR) | 11.1 (7.2–20.1) | 14.2 (7.2–14.2) | – | 0.85 |
| ▸ All reported eczema§,¶ | 119/214 (55.6%) | 132/226 (58.4%) | 0.90 (0.61 to 1.3) | 0.55 |
| ▸ Received topical steroid preparation | 30/214 (14.0%) | 40/226 (17.7%) | 0.76 (0.45 to 1.2) | 0.29 |
| Respiratory | ||||
| ▸ All reported asthma¶ | 23/171 (11.9%) | 20/179 (10.0%) | 1.2 (0.63 to 2.3) | 0.57 |
| ▸ Night-time cough | 156/214 (72.9%) | 164/226 (72.6%) | 1.0 (0.67 to 1.5) | 0.93 |
| ▸ Night-time or daytime cough | 178/214 (83.2%) | 188/226 (83.2%) | 1.0 (0.6 to 1.6) | 0.99 |
| ▸ Wheezing without symptoms of a virus infection | 50/214 (23.4%) | 55/171 (24.3%) | 0.95 (0.61 to 1.47) | 0.81 |
| ▸ Inhaled bronchodilator or steroid | 26/214 (12.1%) | 27/226 (11.9%) | 1.0 (0.57 to 1.8) | 0.94 |
| ▸ Allergic rhinitis¶ | 10/190 (5.3%) | 10/201 (5.0%) | 1.1 (0.43 to 2.6) | 0.90 |
| ▸ Sneezing and/or snuffling | 207/214 (96.7%) | 212/226 (93.8%) | 1.95 (0.77 to 4.93) | 0.15 |
| Any reported food allergy | 22/200 (11.0%) | 31/204 (15.2%) | 0.69 (0.38 to 1.2) | 0.21 |
This table gives the number of participants (%) unless otherwise stated.
*χ2 test for contingency tables or Fisher's exact test* where expected values in cells were <5.
†SPT valid if diameter of wheal for the positive control was ≥1 mm than diameter for the negative control; SPT positive if diameter of wheal for antigen was ≥3 mm than diameter for negative control.
‡SCORAD index19.
§Of any duration.
¶Whether or not diagnosed by a health professional.
SCORAD, scoring atopic dermatitis; SPT, skin prick test.