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ISRCTN
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ISRCTN71058787
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ClinicalTrials.gov identifier
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Public title
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Does the eradication of endoparasites promote allergic disease?
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Scientific title
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Acronym
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DB Study
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Serial number at source
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N/A
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Study hypothesis
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Allergic disease is becoming increasingly frequent in urban centres of developing nations, such as Viet Nam. In this context, the role of endoparasite exposure has been debated for years. Some but not all cross-sectional studies suggest that the relatively high prevalence of allergic disease and atopy in urban areas of developing countries may be partly explained by a reduction in exposure to endoparasites, especially hookworm and Ascaris lumbricoides. It is likely that some of the effects demonstrated in cross-sectional population-based studies are due to confounding or even reverse causality, such that atopics have an immune system that reduces worm burden. Only an intervention study will be able to clarify this matter.
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Lay summary
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Ethics approval
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Nottingham Research Ethics Committee 2, Ref. REC/Q2010305, 3rd Dec 2004
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Study design
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Double blind randomised controlled trial
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Countries of recruitment
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Viet Nam
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Disease/condition/study domain
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Allergic disease, soil-transmitted helminths
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Participants - inclusion criteria
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All primary and secondary school children (age 6-15) in four communes in Khanh Hoa province, central Viet Nam
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Participants - exclusion criteria
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Known allergy to Albendazole
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Anticipated start date
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01/04/2005
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Anticipated end date
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30/06/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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1600
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Interventions
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The original study protocol used three-monthly single dose Mebendazole 500 mg over one year. After the first treatment round, investigators noticed low efficacy of this regime. Therefore, a treatment comparison study was conducted to select the best treatment, and Albendazole 400 mg for three consecutive days was chosen.
The amended protocol compares three-monthly Albendazole versus placebo over 9 months.
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Primary outcome measure(s)
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Change in percent fall in peak expiratory flow after exercise challenge post gut worm treatment
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Secondary outcome measure(s)
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Change in skin prick test hypersensitivity, host cytokine profiles, and allergic disease prevalence (skin examination for eczema and questionnaire-based for wheeze and rhinitis) post gut worm treatment
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Sources of funding
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Asthma UK (UK)
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Trial website
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Publications
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Contact name
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Dr
Carsten
Flohr
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Address
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Oxford University Clinical Research Unit
Hospital for Tropical Diseases
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City/town
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Ho Chi Minh City
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Zip/Postcode
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Country
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Viet Nam
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Email
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flohr@dng.vnn.vn
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Sponsor
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University of Nottingham (UK)
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Address
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Centre for Population Sciences and Centre for Respiratory Research
Institute of Clinical Research
University of Nottingham
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City/town
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Nottingham
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Zip/Postcode
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NG7 2RD
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Country
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United Kingdom
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Email
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j.britton@virgin.net
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Sponsor website:
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http://www.nottingham.ac.uk/icr/
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Date applied
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31/10/2005
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Last edited
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16/10/2008
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Date ISRCTN assigned
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15/11/2005
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