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© Leung et al. 2016. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

Abstract

Background

Anthelmintics 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/design

This 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.

Discussion

In 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 registration

ClinicalTrials.gov: NCT02597556. Registered on 3 November 2015.

Details

Title
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
Author
Leung, Jacqueline M. 1 ; Hong, Chau Tran Thi 2 ; Trung, Nghia Ho Dang 3 ; Thi, Hoa Nhu 4 ; Minh, Chau Nguyen Ngoc 2 ; Thi, Thuy Vu 2 ; Hong, Dinh Thanh 5 ; Man, Dinh Nguyen Huy 6 ; Knowles, Sarah C. L. 7 ; Wolbers, Marcel 8 ; Hoang, Nhat Le Thanh 2 ; Thwaites, Guy 8 ; Graham, Andrea L. 1 ; Baker, Stephen 9 

 Princeton University, Department of Ecology and Evolutionary Biology, Princeton, USA (GRID:grid.16750.35) (ISNI:0000000120975006) 
 Oxford University Clinical Research Unit, The Hospital for Tropical Diseases, Wellcome Trust Major Overseas Programme, Ho Chi Minh City, Vietnam (GRID:grid.412433.3) (ISNI:0000000404296814) 
 Oxford University Clinical Research Unit, The Hospital for Tropical Diseases, Wellcome Trust Major Overseas Programme, Ho Chi Minh City, Vietnam (GRID:grid.412433.3) (ISNI:0000000404296814); Pham Ngoc Thach University of Medicine, Department of Infectious Diseases, Ho Chi Minh City, Vietnam (GRID:grid.412497.d) (ISNI:0000000446593788) 
 Pham Ngoc Thach University of Medicine, Department of Parasitology and Mycology, Ho Chi Minh City, Vietnam (GRID:grid.412497.d) (ISNI:0000000446593788) 
 Cu Chi Preventive Medicine Centre, Ho Chi Minh City, Vietnam (GRID:grid.412433.3) 
 The Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam (GRID:grid.414273.7) 
 The Royal Veterinary College, Department of Pathology and Pathogen Biology, Hertfordshire, UK (GRID:grid.20931.39) (ISNI:000000040425573X) 
 Oxford University Clinical Research Unit, The Hospital for Tropical Diseases, Wellcome Trust Major Overseas Programme, Ho Chi Minh City, Vietnam (GRID:grid.412433.3) (ISNI:0000000404296814); University of Oxford, Centre for Tropical Medicine, Oxford, UK (GRID:grid.4991.5) (ISNI:0000000419368948) 
 Oxford University Clinical Research Unit, The Hospital for Tropical Diseases, Wellcome Trust Major Overseas Programme, Ho Chi Minh City, Vietnam (GRID:grid.412433.3) (ISNI:0000000404296814); University of Oxford, Centre for Tropical Medicine, Oxford, UK (GRID:grid.4991.5) (ISNI:0000000419368948); The London School of Hygiene and Tropical Medicine, London, UK (GRID:grid.8991.9) (ISNI:000000040425469X) 
Pages
279
Publication year
2016
Publication date
Dec 2016
Publisher
BioMed Central
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
2795253388
Copyright
© Leung et al. 2016. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.