Primary and secondary outcomes
| Outcomes | Gelatine tannate group (n=31) | Placebo group (n=33) | P values | MD/RR | 95% CI |
| Duration of diarrhoea, hours, mean (SD) | 75.6 (27.8) | 75.5 (29.0) | 0.99 | 0.1 | −14.1 to 14.3 |
| Need for intravenous rehydration, n (%) | 25 (80.6) | 27 (81.8) | 0.9 | 0.9 | 0.78 to 1.25 |
| Number of watery stools per day* (mean (SD)) | |||||
| Day 1 | 5.5 (3.0) | 4.6 (2.3) | 0.165 | 0.90 | −0.40 to 2.30 |
| Day 2 | 4.7 (2.8) | 3.8 (3.0) | 0.27 | 0.90 | −0.60 to 2.30 |
| Day 3 | 2.6 (3.2) | 2.1 (2.9) | 0.50 | 0.50 | −1.00 to 2.10 |
| Day 4 | 1.2 (1.7) | 1.0 (1.3) | 0.62 | 0.20 | −0.60 to 1.00 |
| Day 5 | 0.5 (1.3) | 0.4 (1.5) | 0.87 | 0.10 | −0.60 to 0.80 |
| Day 6 | 0.06 (0.4) | 0.1 (0.7) | 0.68 | −0.10 | −0.30 to 0.20 |
| Day 7 | 0.0 (0.0) | 0.0 (0.0) | NA | 0.00 | 0.00 to 0.00 |
| Vomiting, n (%) | 25 (80.6%) | 21 (63.6%) | 0.22 | 1.27 | 0.93 to 1.73 |
| Weight gain, g±SD | 70±142 | 129±155 | 0.12 | −59.1 | −133.1 to 15 |
| Recurrence of diarrhoea (48 hours after intervention), n (%) | 0 | 4 (12) | 0.12 | 0.12 | 0.01 to 2.11 |
| Severity of diarrhoea according to Vesikari Scale (mean (SD)) | 9.7 (3.4) | 8.6 (3.9) | 0.24 | 1.10 | −0.70 to 2.90 |
| Need for hospitalisation in outpatients, n | 0 | 0 | – | – | – |
| Adverse events, n (%) | 3 (9.6%) | 5 (15.1%) | 0.7 | 0.64 | 0.17 to 2.45 |
| Spitting after the administration | 0 | 2 (6.1%) | 0.49 | 0.21 | 0.01 to 4.26 |
| Abdominal pain | 1 (3.2%) | 0 | 0.48 | 3.19 | 0.13 to 75.43 |
*According to the Bristol Stool Form Scale (BSF) or Amsterdam Stool Form (ASF) Scale (on BSF scale, numbers 2, 3, 4 and 5; on ASF scale, letters B or C).
MD, mean or median difference, as appropriate; NA, not applicable; RR, relative risk.