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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; Chau, Nguyen Ngoc Minh MSc; Hoang Le, Nhat Thanh PhD; The, Hao Chung MSc; Voong Vinh, Phat MSc; To, Nguyen Thi Nguyen MSc; Ngoc, Nguyen Minh MD; Tuan, Ha Manh MD; Ngoc, Tang Le Chau 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: Post Acceptance: August 01, 2017
doi: 10.1097/INF.0000000000001712
Original Studies: PDF Only

Background:

Probiotics are the most frequently prescribed treatment for children hospitalized with diarrhea in Vietnam. We were in 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 two 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 endpoint 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:

150 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 (inter-quartile range (IQR) 15-66 hours) in the placebo group and 35 hours (IQR 20-68 hours) in the probiotic group (acceleration factor 1.09 (95% confidence interval 1.78-1.51); p=1.62). There was also no evidence that probiotic treatment was efficacious in any of the pre-defined subgroups nor significantly associated with any secondary endpoint.

Conclusions:

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

† Oxford-Vietnam probiotics study group defined in acknowledgements

Funding: This work was supported by The Wellcome Trust and the OAK Foundation. SB 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.

Conflicts of interest: None to declare

Acknowledgements: The Oxford-Vietnam probiotics study group are: Named authors and James I Campbell, Laura Merson, Corinne N Thompson, and Ha Thanh Tuyen from The Wellcome Trust Major Overseas Programme, Vo Thi Van, Nguyen Hong Van Khanh, Nguyen Thi Hong Loan, Nguyen Thi Thu Thu, Vo Hoang Khoa, Nguyen Cam Tu, Nguyen Thi Thanh Tam from Children’s Hospital, and Ha Vinh from Pham Ngoc Thach Medical University. We are indebted to the patients and their relatives for their participation in the trial. We wish to acknowledge the doctors and nurses of Children’s Hospital 2 who cared for the children enrolled in this study, specifically: Nguyen Thi Phuong Dung, Nguyen Van Vinh Chau, Nguyen Thi Ho Diep, Pham Thi Ngoc Tuyet, Ho Lu Viet, Hoang Minh Tu Van, Lu Lan Vi, Do Thi Phuong Trang, Lam Boi Hy, Nguyen Thi Kim Ngan, Ms Pham Thi Mai Anh, Tran Thi Tuyet Minh, Tran Thi Minh Phuong, Tran Thi Tuyet Nga, and Vu Thi Thuy. This work was supported by The Wellcome Trust and the OAK Foundation. SB 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.

* Corresponding Author: Professor Stephen Baker, the Hospital for Tropical Diseases, 764 Vo Van Kiet, Quan 5, Ho Chi Minh City, Vietnam. Tel: +84 89241761; Fax: +84 89238904; Email: sbaker@oucru.org

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