Evolution of the symptom-based score (SBS)
| Before challenge (n:39) | Inclusion (n:37) | 1 month (n:37) | p Value | |
|---|---|---|---|---|
| Global-score | ||||
| Mean±SD (CI 95%) | 9.4±6.1 (7.4 to 11.4) | 13.0±5.2 (11.3 to 14.7) | <0.0001* | |
| 13.0±5.2 (11.3 to 14.7) | 3.5±2.3 (2.7 to 4.3) | <0.0001* | ||
| Crying (%), (CI 95%) | ||||
| <1 h/day | 13.5 (2.5 to 24.5) | 64.9 (49.5 to 80.2) | ||
| 1.5 h/day | 5.4 (0.0 to 12.7) | 21.6 (8.4 to 34.9) | ||
| 2 h/day | 5.4 (0.0 to 12.7) | 10.8 (0.8 to 20.8) | ||
| 2–3 h/day | 18.9 (6.3 to 31.5) | 2.7 (0.0 to 7.9) | ||
| 3–4 h/day | 18.9 (6.3 to 31.5) | 0.0 | ||
| 4–5 h/day | 5.4 (0.0 to 12.7) | 0.0 | ||
| >5 h/day | 32.4 (17.3 to 47.5) | 0.0 | ||
| Crying (%), (CI 95%) | ||||
| Crying <3 h/day | 43.2 (27.3 to 59.2) | 100.0 (100.0 to 100.0) | <0.0001† | |
| Crying ≥3 h/day | 56.7 (40.8 to 72.7) | 0.0 | ||
| Crying score‡ | ||||
| Mean±SD, (CI 95%) | 3.7±2.1 (3.0 to 4.4) | 0.5±0.8 (0.2 to 0.8) | <0.001§ | |
| Regurgitations score27‡ | ||||
| Mean±SD, (CI 95%) | 2.4±2.2 (1.6 to 3.1) | 0.6±0.9 (0.4 to 0.9) | <0.0001* | |
| Stools (%), (CI 95%)28 | ||||
| Type I/II (hard) | 27.0 (12.7 to 41.3) | 8.1 (0.0 to 16.9) | ||
| Type III/IV (normal) | 5.4 (0.0 to 12.7) | 54.1 (38.0 to 70.1) | ||
| Type V (soft) | 10.8 (0.8 to 20.8) | 8.1 (0.0 to 16.9) | ||
| Type VI (mushy) | 32.4 (17.3 to 47.5) | 27.0 (12.7 to 41.3) | ||
| Type VII (watery) | 24.3 (10.5 to 38.1) | 2.7 (0.0 to 7.9) | ||
| Stools (%), (CI 95%) | ||||
| Normal stools (types III, IV) | 5.4 (0.0 to 12.7) | 54.1 (38.0 to 70.1) | <0.0001† | |
| Non-normal stools (types I, II, V, VI) | 94.5 (87.3 to 100) | 45.9 (29.9 to 62.0) | ||
| Urticaria (%), (CI 95%) | ||||
| Present | 16.2 (4.3 to 28.1) | 0.0 | 0.0143† | |
| Absent | 83.8 (71.9 to 95.7) | 100.0 (100.0 to 100.0) | ||
| Eczema (%), (CI 95%) | ||||
| Head, neck, trunk | ||||
| Absent | 51.4 (35.2 to 67.5) | 78.4 (65.1 to 91.6) | 0.0348¶ | |
| Mild | 18.9 (6.3 to 31.5) | 18.9 (6.3 to 31.5) | ||
| Moderate | 18.9 (6.3 to 31.5) | 2.7 (0.0 to 7.9) | ||
| Severe | 10.8 (0.8 to 20.8) | 0.0 | ||
| Arms, hands, legs, feet | ||||
| Absent | 64.9 (49.5 to 80.2) | 86.5 (75.5 to 97.5) | 0.1557¶ | |
| Mild | 10.8 (0.8 to 20.8) | 13.5 (2.5 to 24.5) | ||
| Moderate | 13.5 (2.5 to 24.5) | |||
| Severe | 10.8 (0.8 to 20.8) | |||
| Respiratory symptoms (%), (CI 95%) | ||||
| No | 75.7 (61.9 to 89.5) | 81.1 (68.5 to 93.7) | 0.5062¶ | |
| Mild | 18.9 (6.3 to 31.5) | 13.5 (2.5 to 24.5) | ||
| Moderate | 5.4 (0.0 to 12.7) | 5.4 (0.0 to 12.7) | ||
Stools were scored according to the Bristol stool scale28. *Paired Student t test. †McNemar test.
‡Sub-scores included in the calculation of the SBS score. §Wilcoxon test. ¶Symmetry test.