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. 2025 Jan 23;9(1):e003133. doi: 10.1136/bmjpo-2024-003133

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.