The impact of albendazole treatment on the incidence of viral- and bacterial-induced diarrhea in school children in southern Vietnam: study protocol for a randomized controlled trialReport as inadecuate




The impact of albendazole treatment on the incidence of viral- and bacterial-induced diarrhea in school children in southern Vietnam: study protocol for a randomized controlled trial - Download this document for free, or read online. Document in PDF available to download.

Trials

, 17:279

First Online: 06 June 2016Received: 02 December 2015Accepted: 25 May 2016DOI: 10.1186-s13063-016-1406-1

Cite this article as: Leung, J.M., Hong, C.T.T., Trung, N.H.D. et al. Trials 2016 17: 279. doi:10.1186-s13063-016-1406-1

Abstract

BackgroundAnthelmintics are one of the more commonly available classes of drugs to treat infections by parasitic helminths especially nematodes in the human intestinal tract. As a result of their cost-effectiveness, mass school-based deworming programs are becoming routine practice in developing countries. However, experimental and clinical evidence suggests that anthelmintic treatments may increase susceptibility to other gastrointestinal infections caused by bacteria, viruses, or protozoa. Hypothesizing that anthelmintics may increase diarrheal infections in treated children, we aim to evaluate the impact of anthelmintics on the incidence of diarrheal disease caused by viral and bacterial pathogens in school children in southern Vietnam.

Methods-designThis is a randomized, double-blinded, placebo-controlled trial to investigate the effects of albendazole treatment versus placebo on the incidence of viral- and bacterial-induced diarrhea in 350 helminth-infected and 350 helminth-uninfected Vietnamese school children aged 6–15 years. Four hundred milligrams of albendazole, or placebo treatment will be administered once every 3 months for 12 months. At the end of 12 months, all participants will receive albendazole treatment. The primary endpoint of this study is the incidence of diarrheal disease assessed by 12 months of weekly active and passive case surveillance. Secondary endpoints include the prevalence and intensities of helminth, viral, and bacterial infections, alterations in host immunity and the gut microbiota with helminth and pathogen clearance, changes in mean z scores of body weight indices over time, and the number and severity of adverse events.

DiscussionIn order to reduce helminth burdens, anthelmintics are being routinely administered to children in developing countries. However, the effects of anthelmintic treatment on susceptibility to other diseases, including diarrheal pathogens, remain unknown. It is important to monitor for unintended consequences of drug treatments in co-infected populations. In this trial, we will examine how anthelmintic treatment impacts host susceptibility to diarrheal infections, with the aim of informing deworming programs of any indirect effects of mass anthelmintic administrations on co-infecting enteric pathogens.

Trial registrationClinicalTrials.gov: NCT02597556. Registered on 3 November 2015.

KeywordsAlbendazole Deworming Soil-transmitted helminths Diarrhea Co-infection Electronic supplementary materialThe online version of this article doi:10.1186-s13063-016-1406-1 contains supplementary material, which is available to authorized users.

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Author: Jacqueline M. Leung - Chau Tran Thi Hong - Nghia Ho Dang Trung - Hoa Nhu Thi - Chau Nguyen Ngoc Minh - Thuy Vu Thi

Source: https://link.springer.com/







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