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Racecadotril did not improve diarrhoeal symptoms in children with moderate acute gastroenteritis

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Study design

Design

Randomised controlled trial (RCT).

Allocation

Computer-generated block randomisation.

Blinding

Open-label (not explicitly stated).

Study question

Setting

Spanish tertiary paediatric accident and emergency department

Patients

A total of 189 children aged 3–36 months with acute gastroenteritis, defined as at least three loose stools within the preceding 24 h. Patients who had symptoms for more than 7 days, and those requiring hospitalisation were excluded.

Intervention

Of the 179 patients that were included in the efficacy analysis, 91 received standard oral rehydration solution (ORS) while 88 received ORS plus racecadotril (ORS+R). Racecadotril treatment was discontinued when the patient had two stools of normal consistency, or no bowel movement in the preceeding 12 h. Patients were re-assessed after 48 h and at 7 days.

Outcomes

The primary outcome was reduction of bowel movements within 48 h of initiating therapy. Secondary outcomes were duration of diarrhoea, number of doctor visits in the interim and safety and tolerability of the study drug.

Follow-up period

One week in total. High proportion of drop-outs: 137/189 (72%) patients returned …

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