Table 2. Clinical and laboratory outcomes according to intervention arm.
Variable | Control groupN=24 | Intervention groupN=25 | Difference in means (95% CI) | P value |
Duration of diarrhoea; time to (hours)* | ||||
Last watery/loose stool | 24; 38.7 (22.0) | 25; 19.6 (15.5) | −19.3 (−30.9 to −7.8) | 0.0016 |
First formed stool | 24; 49.3 (23.1) | 24; 31.1 (14.5) | −16.6 (−28.5 to −4.7) | 0.0075 |
No. watery stools | ||||
0–4 hours | 23; 0.7 (0.9) | 24; 0.6 (0.7) | 0.0 (−0.5 to 0.5) | >0.99 |
Day 2 | 23; 2.4 (1.2) | 24; 1.6 (0.9) | −0.8 (−1.3 to −0.3) | 0.0022 |
Day 3 | 23; 1.3 (1.0 | 24; 0.5 (0.8) | −0.8 (−1.3 to −0.3) | 0.0014 |
Day 4 | 13; 0.9 (0.9) | 2; 0.0 (0.0) | −1.0 (−2.3 to 0.3) | 0.13 |
Day 5 | 1; 2.0 (−) | 0; − | – | – |
Volume of study treatment taken 0–4 hours* | ||||
mL/kg | 25; 26.7 (14.7) | 25; 25.6 (14.0) | 1.2 (−4.2 to 6.6) | 0.65 |
% prescribed | 25; 92.3 (18.7) | 25; 93.0 (30.6) | 4.7 (−9.0 to 18.4) | 0.49 |
Change in weight 0–4 hours (kg) | 25; 0.20 (0.44) | 25; 0.57 (0.65) | 0.29 (−0.23 to 0.80) | 0.28 |
Volume of study treatment taken in phase 2 (cups) | ||||
Day 2 | 23; 3.1 (0.8) | 25; 3.3 (0.7) | 0.2 (−0.3 to 0.7) | 0.51 |
Day 3 | 24; 1.8 (1.1) | 25; 2.3 (0.9) | 0.5 (0.0 to 1.0) | 0.07 |
Day 4 | 13; 1.8 (0.8) | 2; 1.0 (0.0) | −0.8 (−2.1 to 0.5) | 0.23 |
Day 5 | 1; 3.0 (−) | 0; − | – | – |
Laboratory indices: change between baseline and 4 hours* | ||||
Haemoglobin (g/L) | 21; −0.3 (1.0) | 21; −0.2 (0.9) | 0.2 (−0.3 to 0.8) | 0.43 |
Sodium (mmol/L) | 21; 1.3 (3.2) | 21; 0.2 (2.0) | −1.3 (−3.0 to 0.3) | 0.11 |
Potassium (mmol/L) | 21; 0.1 (1.5) | 21; 0.0 (0.4) | −0.4 (−1.0 to 0.2) | 0.20 |
Creatinine (μmol/L) | 21; −0.4 (2.1) | 20; −4.2 (19.9) | 0.3 (−0.7 to 1.4) | 0.52 |
All values are number; mean (SD).
Statistically significant differences are shown in bold type.
aAdjusted for age, sex, time from diarrhoea onset to randomisation, and hydration status.