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A Double-blind, Randomized, Placebo-controlled Trial of Lactobacillus acidophilus for the Treatment of Acute Watery Diarrhea in Vietnamese Children

Hong Chau, Tran Thi MD*; Minh Chau, Nguyen Ngoc MSc*; Hoang Le, Nhat Thanh PhD*; Chung The, Hao MSc*; Voong Vinh, Phat MSc*; Nguyen To, Nguyen Thi MSc*; Ngoc, Nguyen Minh MD; Tuan, Ha Manh MD; Chau Ngoc, Tang Le MD; Kolader, Marion-Eliette MD; Farrar, Jeremy J. MD; Wolbers, Marcel PhD; Thwaites, Guy E. MD; Baker, Stephen PhD*§¶on behalf of the Oxford-Vietnam Probiotics Study Group

The Pediatric Infectious Disease Journal: January 2018 - Volume 37 - Issue 1 - p 35–42
doi: 10.1097/INF.0000000000001712
Original Studies

Background: Probiotics are the most frequently prescribed treatment for children hospitalized with diarrhea in Vietnam. We were uncertain of the benefits of probiotics for the treatment of acute watery diarrhea in Vietnamese children.

Methods: We conducted a double-blind, placebo-controlled, randomized trial of children hospitalized with acute watery diarrhea in Vietnam. Children meeting the inclusion criteria (acute watery diarrhea) were randomized to receive either 2 daily oral doses of 2 × 108 CFUs of a local probiotic containing Lactobacillus acidophilus or placebo for 5 days as an adjunct to standard of care. The primary end point was time from the first dose of study medication to the start of the first 24-hour period without diarrhea. Secondary outcomes included the total duration of diarrhea and hospitalization, daily stool frequency, treatment failure, daily fecal concentrations of rotavirus and norovirus, and Lactobacillus colonization.

Results: One hundred and fifty children were randomized into each study group. The median time from the first dose of study medication to the start of the first 24-hour diarrhea-free period was 43 hours (interquartile range, 15–66 hours) in the placebo group and 35 hours (interquartile range, 20–68 hours) in the probiotic group (acceleration factor 1.09 [95% confidence interval, 0.78–1.51]; P = 0.62). There was also no evidence that probiotic treatment was efficacious in any of the predefined subgroups nor significantly associated with any secondary end point.

Conclusions: This was a large double-blind, placebo-controlled trial in which the probiotic underwent longitudinal quality control. We found under these conditions that L. acidophilus was not beneficial in treating children with acute watery diarrhea.

Supplemental Digital Content is available in the text.

*The Hospital for Tropical Diseases, Wellcome Trust Major Overseas Programme, Oxford University Clinical Research Unit, and Children’s Hospital 2 (CH2), Ho Chi Minh City, Vietnam; Department of Medical Microbiology, Academic Medical Centre, Amsterdam, The Netherlands; §Centre for Tropical Medicine, Oxford University, Oxford, United Kingdom; and The Department of Medicine, The University of Cambridge, Cambridge, United Kingdom.

Accepted for publication May 14, 2017.

‖ Oxford-Vietnam Probiotics Study Group defined in acknowledgements.

Supported by The Wellcome Trust and the OAK Foundation. S.B. is funded by a Sir Henry Dale Fellowship from the Wellcome Trust and the Royal Society(100087/Z/12/Z). The funders had no role in interpretation or publication of the data.

Role of Funding Source: The funder of the study had no role in study design, data collection, data analysis, data interpretation or writing of the report.

The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication.

The authors have no conflicts of interest to disclose.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s website (www.pidj.com).

Address for correspondence: Stephen Baker, PhD, The Hospital for Tropical Diseases, 764 Vo Van Kiet, Quan 5, Ho Chi Minh City, Vietnam. E-mail: sbaker@oucru.org

This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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