Abstract
BackgroundDiarrhoeal disease is a major global health problem, particularly affecting children under the age of 5 years. Besides oral rehydration solution, probiotics are also commonly prescribed to children with acute watery diarrhoea in some settings. Results from randomised clinical trials (RCTs) in which investigators studied the effect of probiotics on diarrhoeal symptoms have largely shown a positive effect; yet, the overall quality of the data is limited. In Vietnam, probiotics are the most frequently prescribed treatment for children hospitalised with acute watery diarrhoea, but there is little justification for this treatment in this location. We have designed a RCT to test the hypothesis that an oral preparation of Lactobacillus acidophilus is superior to placebo in the treatment of acute watery diarrhoea in Vietnamese children.MethodsThis RCT was designed to study the effect of treatment with L. acidophilus (4 × 109 colony-forming units/day) for 5 days for acute watery diarrhoea against a placebo in 300 children ages 9 to 60 months admitted to hospitals in Vietnam. Clinical and laboratory data plus samples will be collected on admission, daily during hospitalisation, at discharge, and at follow-up visits for a subset of participants. The primary end point will be defined as the time from the first dose of study medication to the start of the first 24-hour period without diarrhoea as assessed by the on-duty nurse. Secondary endpoints include the time to cessation of diarrhoea as recorded by parents or guardians in an hourly checklist, stool frequency over the first 3 days, treatment failure, rotavirus and norovirus viral loads, and adverse events.DiscussionThe existing evidence for the use of probiotics in treating acute watery diarrhoea seems to favour their use. However, the size of the effect varies across publications. An array of different probiotic organisms, doses, treatment durations, study populations, designs, settings, and aetiologies have been described. In this trial, we will investigate whether probiotics are beneficial as an adjuvant treatment for children with acute watery diarrhoea in Vietnam, with the aim of guiding clinical practice through improved regional evidence.Trial registrationCurrent Controlled Trials ISRCTN88101063
Highlights
Diarrhoeal disease is a major global health problem, affecting children under the age of 5 years
Children who are withdrawn or lost to follow-up before the cessation of diarrhoea will be treated as Discussion Diarrhoeal disease in young children remains common in low- and middle-income countries such as Vietnam
The main therapy for diarrhoea consists of Oral rehydration solution (ORS) and zinc, which are frequently supplemented with antimicrobials in severe cases with a suspected bacterial aetiology
Summary
Diarrhoeal disease in young children remains common in low- and middle-income countries such as Vietnam. Published studies on the effect of probiotics in treating acute watery diarrhoea in children have compared one or more of the following end points: reduction of diarrhoea duration, stool frequency, hospitalisation duration, virus in faeces and evidence of colonisation of probiotic bacteria. A meta-analysis by Van Niel et al suggested a positive linear association between the dosage of Lactobacillus and the reduction in diarrhoea duration, when the results from eight studies reporting reduction in diarrhoea as the outcome, comparing Lactobacillus treatment to placebo, were analysed [43] In this trial, we will use just a single dose of probiotic to compare to placebo; we will be unable to show a dose–response effect.
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