Evaluating the Efficacy of Racecadotril in Combination with Oral Rehydration in Children with Acute Diarrhoea: A Randomised Controlled Trial

1. Assistant Professor, Department of Paediatrics, Ballari Medical College and Research Centre, Ballari, Karnataka, India. 2. Assistant Professor, Department of Paediatrics, East Point College of Medical Sciences and Research Centre, Bangalore, Karnataka, India. 3. Assistant Professor, Department of Paediatrics, The Oxford Medical College Hospital and Research Centre, Bangalore, Karnataka, India.

Abstract

Introduction: Acute watery diarrhoea in early childhood frequently necessitates hospital admission. Although Oral Rehydration Salts (ORS) with zinc effectively prevent and treat dehydration, they do not consistently shorten illness duration or reduce early stool losses. Racecadotril, a motility-sparing antisecretory agent, may help address this therapeutic gap.

Aim: To evaluate whether adding racecadotril to ORS plus zinc improves short-term clinical outcomes in hospitalised infants and toddlers with acute watery diarrhoea.

Materials and Methods: A randomised, double-blind, parallel-group, placebo-controlled trial was conducted in the paediatric wards of the Indira Gandhi Institute of Child Health (IGICH), Bengaluru, Karnataka, India. A total of 140 children aged 3-24 months with non dysenteric acute watery diarrhoea and mild-to-moderate dehydration were allocated (1:1) to receive either racecadotril (1.5 mg/kg every 8 hours, up to 5 days) plus ORS and zinc, or a matching placebo plus ORS and zinc. The primary endpoint was duration of hospital stay (hours). Secondary endpoints included stool frequency (Days 1-3), stool consistency (Days 1-3), and total ORS requirement. Analyses followed intention-to-treat principles; Mann–Whitney U and covariate-adjusted ANCOVA were used for continuous outcomes, and χ² tests for proportions. A p-value of <0.05 was considered as statistically significant.

Results: Racecadotril significantly improved outcomes in children with acute diarrhoea (p-value <0.001). Compared with the control group, it shortened hospital stay by nearly 17 hours (p-value <0.001) and consistently reduced stool frequency over the first three days of treatment (day 1, p-value=0.001; day 2, p-value=0.003; day 3, p-value=0.018). By day 2, a greater proportion of children receiving racecadotril passed formed stools (41.4% vs 21.4%; p-value=0.010), though this difference was no longer evident by day 3 (p-value=0.149). ORS requirement was also markedly lower in the racecadotril group (p-value <0.001). Adverse Events (AEs) were rare, mild, and comparable between groups (5.7% each; p-value>0.05), with no serious events reported, underscoring the favourable safety profile of racecadotril.

Conclusion: Racecadotril, when used as an adjunct to ORS and zinc in infants and toddlers with acute watery diarrhoea, may offer meaningful clinical benefits by accelerating recovery, reducing treatment burden, and enabling earlier discharge, all without added safety concerns.

Antidiarrhoeals, Dehydration therapy, Enkephalinase inhibitors, Fluid therapy, Gastroenteritis therapy, Hospitalisation, Length of stay, Zinc/therapeutic use