Cézard 2001.

Methods	Randomized, double‐blinded, placebo‐controlled trial Length of follow‐up: till recovery
Participants	Number: 168 Inclusion criteria: Children of both genders aged 3 months to 4 years who had watery diarrhoea (3 or more watery stools per day) of less than 72 hours' duration. Before inclusion, each patient had to pass at least 1 watery stool at the hospital. Exclusion criteria: Patients who had chronic diarrhoea, a weight‐for‐age deficit of 20% or more of National Center for Health Statistics standards, or a systemic illness or had received an antibiotic, antidiarrhoeal drug, or acetylsalicylic acid within the preceding 48 hours. Missing data: 47 participants
Interventions	Group 1: 86 received racecadotril additional to oral rehydration Group 2: 82 received placebo additional to oral rehydration Racecadotril was given 1.5 mg/kg of body weight, orally every 8 hours.
Outcomes	Stool output in the first 48 hours. Stool weight was measured every 12 hours for the first 48 hours by subtracting the weight of pre‐weighed diapers from that of used diapers. Stool output during the first 24 hours Na/K ratio of urine Duration of diarrhoea. The time to recovery was analysed using Kaplan–Meier curves Number and characteristics of stools. Tolerability
Notes	Location: France Source of funding was not reported, but some of the authors were from the pharmaceutical industry.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Method of random sequence generation was not reported
Allocation concealment (selection bias)	Unclear risk	Not mentioned
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double‐blinded; both drug treatments were given as granules of the same appearance and taste
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Double‐blinded placebo‐controlled
Incomplete outcome data (attrition bias) All outcomes	High risk	The total amount of attrition was 28% (more than 20%). The number of loss to follow‐up was balanced in 2 groups but the reasons for loss to follow was not balanced.
Selective reporting (reporting bias)	Unclear risk	The trial protocol is not available. It was unknown if outcomes were selectively reported.
Other bias	High risk	Source of funding was not reported, but some of the authors were from the pharmaceutical industry.