Table 1.
Demographic and Clinical Characteristics.
| Total, n = 85 | Control, n = 42 | Prodefen®, n = 43 | P | |
|---|---|---|---|---|
| Age | ||||
| Mean ± SD, years | 3.5 ± 3.2 | 3.6 ± 3.4 | 3.4 ± 3.1 | 0.803 |
| 6 months to 2 years, n (%) | 41 (48.2) | 19 (45.2) | 22 (51.2) | 0.584 |
| 3-5 years, n (%) | 22 (25.9) | 13 (31.0) | 9 (20.9) | 0.292 |
| 6-12 years, n (%) | 22 (25.9) | 10 (23.8) | 12 (27.9) | 0.666 |
| Sex (boys), n (%) | 36 (42.4) | 17 (40.5) | 19 (44.2) | 0.729 |
| Weight (kg), median (IQR) | 14.0 (10.1-20.5) | 14.4 (9.5-21.2) | 14.0 (10.3-20.0) | 0.937 |
| Height (cm), median (IQR) | 98.0 (81.3-117.3) | 98.0 (82.0-116.5) | 93.0 (81.0-118.0) | 0.943 |
| BMI (kg/m2), median (IQR) | 15.6 (14.8-16.6) | 15.7 (14.6-16.6) | 15.4 (14.8-16.8) | 0.939 |
| Abnormal physical examination, n (%) | 4 (4.7) | 2 (4.8) | 2 (4.7) | 0.999 |
| Number of stools | ||||
| Median (IQR) | 5 (3-6) | 5 (3-6) | 5 (4-6) | 0.824 |
| ≥5 stools, n (%) | 47 (55.3) | 23 (54.8) | 24 (55.8) | 0.992 |
| Symptoms,a n (%) | ||||
| No symptoms | 12 (14.1) | 8 (19.0) | 4 (9.3) | 0.175 |
| Fever | 30 (35.3) | 18 (42.9) | 12 (27.9) | 0.149 |
| Vomiting | 25 (29.4) | 13 (31.0) | 12 (27.9) | 0.758 |
| Mucus on stools | 24 (28.2) | 11 (26.2) | 13 (30.2) | 0.679 |
| Abdominal pain | 55 (64.7) | 23 (54.8) | 32 (74.4) | 0.058 |
| Number of symptoms, median (IQR) | 2 (1-2) | 2 (1-3) | 2 (1-2) | 0.956 |
Abbreviations: IQR, interquartile range; BMI, body mass index.
a
Reported by at least 5% of the children.