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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 …
Footnotes
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Sources of funding The manufacturer of racecadotril (Ferrer Internacional) provided funding for the study (including for study drugs and statistical analysis).
Footnotes
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Provenance and peer review Commissioned; not externally peer reviewed.