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.
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.



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.



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.



ClinicalTrials.gov: NCT02597556 . Registered on 3 November 2015.
Department of Ecology and Evolutionary Biology, Princeton University, Princeton, NJ, USA.
Jacqueline M
JM
Leung
The Hospital for Tropical Diseases, Wellcome Trust Major Overseas Programme, Oxford University Clinical Research Unit, 764 Vo Van Kiet, Quan 5, Ho Chi Minh City, Vietnam.
Chau Tran Thi
CT
Hong
The Hospital for Tropical Diseases, Wellcome Trust Major Overseas Programme, Oxford University Clinical Research Unit, 764 Vo Van Kiet, Quan 5, Ho Chi Minh City, Vietnam.|Department of Infectious Diseases, Pham Ngoc Thach University of Medicine, Ho Chi Minh City, Vietnam.
Nghia Ho Dang
NH
Trung
Department of Parasitology and Mycology, Pham Ngoc Thach University of Medicine, Ho Chi Minh City, Vietnam.
Hoa Nhu
HN
Thi
The Hospital for Tropical Diseases, Wellcome Trust Major Overseas Programme, Oxford University Clinical Research Unit, 764 Vo Van Kiet, Quan 5, Ho Chi Minh City, Vietnam.
Chau Nguyen Ngoc
CN
Minh
The Hospital for Tropical Diseases, Wellcome Trust Major Overseas Programme, Oxford University Clinical Research Unit, 764 Vo Van Kiet, Quan 5, Ho Chi Minh City, Vietnam.
Thuy Vu
TV
Thi
Cu Chi Preventive Medicine Centre, Ho Chi Minh City, Vietnam.
Dinh Thanh
DT
Hong
The Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.
Dinh Nguyen Huy
DN
Man
Department of Pathology and Pathogen Biology, The Royal Veterinary College, Hertfordshire, UK.
Sarah C L
SC
Knowles
The Hospital for Tropical Diseases, Wellcome Trust Major Overseas Programme, Oxford University Clinical Research Unit, 764 Vo Van Kiet, Quan 5, Ho Chi Minh City, Vietnam.|Centre for Tropical Medicine, University of Oxford, Oxford, UK.
Marcel
M
Wolbers
The Hospital for Tropical Diseases, Wellcome Trust Major Overseas Programme, Oxford University Clinical Research Unit, 764 Vo Van Kiet, Quan 5, Ho Chi Minh City, Vietnam.
Nhat Le Thanh
Nle T
Hoang
The Hospital for Tropical Diseases, Wellcome Trust Major Overseas Programme, Oxford University Clinical Research Unit, 764 Vo Van Kiet, Quan 5, Ho Chi Minh City, Vietnam.|Centre for Tropical Medicine, University of Oxford, Oxford, UK.
Guy
G
Thwaites
Department of Ecology and Evolutionary Biology, Princeton University, Princeton, NJ, USA.
Andrea L
AL
Graham
The Hospital for Tropical Diseases, Wellcome Trust Major Overseas Programme, Oxford University Clinical Research Unit, 764 Vo Van Kiet, Quan 5, Ho Chi Minh City, Vietnam. sbaker@oucru.org.|Centre for Tropical Medicine, University of Oxford, Oxford, UK. sbaker@oucru.org.|The London School of Hygiene and Tropical Medicine, London, UK. sbaker@oucru.org.
Stephen
S
Baker
D000293:Adolescent; D000367:Age Factors; D015766:Albendazole / Q000008:administration & dosage / Q000009:adverse effects*; D000871:Anthelmintics / Q000008:administration & dosage / Q000009:adverse effects*; D002648:Child; D002985:Clinical Protocols; D003967:Diarrhea / Q000175:diagnosis / Q000453:epidemiology* / Q000382:microbiology / Q000821:virology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006373:Helminthiasis / Q000175:diagnosis / Q000453:epidemiology / Q000469:parasitology / Q000517:prevention & control*; D006801:Humans; D015994:Incidence; D008297:Male; D009894:Opportunistic Infections / Q000175:diagnosis / Q000453:epidemiology* / Q000382:microbiology / Q000821:virology; D015995:Prevalence; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D014744:Vietnam / Q000453:epidemiology
D000871:Anthelmintics; D015766:Albendazole
Albendazole; Co-infection; Deworming; Diarrhea; Soil-transmitted helminths