Contact information
Type
Scientific
Primary contact
Dr Carsten Flohr
ORCID ID
Contact details
Oxford University Clinical Research Unit
Hospital for Tropical Diseases
Ho Chi Minh City
Viet Nam
flohr@dng.vnn.vn
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
DB Study
Study hypothesis
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.
Ethics approval
Nottingham Research Ethics Committee 2, Ref. REC/Q2010305, 3rd Dec 2004
Study design
Double blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Allergic disease, soil-transmitted helminths
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Albendazole
Primary outcome measures
Change in percent fall in peak expiratory flow after exercise challenge post gut worm treatment
Secondary outcome measures
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
Overall trial start date
01/04/2005
Overall trial end date
30/06/2006
Reason abandoned
Eligibility
Participant inclusion criteria
All primary and secondary school children (age 6-15) in four communes in Khanh Hoa province, central Viet Nam
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
1600
Participant exclusion criteria
Known allergy to Albendazole
Recruitment start date
01/04/2005
Recruitment end date
30/06/2006
Locations
Countries of recruitment
Viet Nam
Trial participating centre
Oxford University Clinical Research Unit
Ho Chi Minh City
Viet Nam
Sponsor information
Organisation
University of Nottingham (UK)
Sponsor details
Centre for Population Sciences and Centre for Respiratory Research
Institute of Clinical Research
University of Nottingham
Nottingham
NG7 2RD
United Kingdom
j.britton@virgin.net
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Asthma UK (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary