An oral preparation of Lactobacillus acidophilus for the treatment of uncomplicated acute watery diarrhoea in Vietnamese children: study protocol for a multicentre, randomised, placebo-controlled trial.
BACKGROUND
Diarrhoeal 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.


METHODS
This 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.


CONCLUSIONS
The 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.


BACKGROUND
Current Controlled Trials ISRCTN88101063.
The Hospital for Tropical Diseases, Wellcome Trust Major Overseas Programme, Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.
Marion-Eliëtte
ME
Kolader
Ha
H
Vinh
Pham Thi
PT
Ngoc Tuyet
Corinne
C
Thompson
Marcel
M
Wolbers
Laura
L
Merson
James I
JI
Campbell
Tran Thi
TT
Ngoc Dung
Ha
H
Manh Tuan
Nguyen Van
NV
Vinh Chau
Jeremy
J
Farrar
H Rogier
HR
van Doorn
Stephen
S
Baker
D000208:Acute Disease; D000284:Administration, Oral; D002675:Child, Preschool; D003625:Data Collection; D003967:Diarrhea / Q000188:drug therapy*; D006801:Humans; D007223:Infant; D007779:Lactobacillus acidophilus; D019936:Probiotics / Q000009:adverse effects / Q000627:therapeutic use*; D018401:Sample Size; D014744:Vietnam