Does the eradication of endoparasites promote allergic disease?

ISRCTN	ISRCTN71058787
DOI	https://doi.org/10.1186/ISRCTN71058787
Secondary identifying numbers	N/A

Submission date: 31/10/2005
Registration date: 15/11/2005
Last edited: 16/10/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Carsten Flohr
Scientific

Oxford University Clinical Research Unit
Hospital for Tropical Diseases
Ho Chi Minh City
Viet Nam

Email	flohr@dng.vnn.vn

Study information

Study design	Double blind randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	DB Study
Study objectives	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(s)	Nottingham Research Ethics Committee 2, Ref. REC/Q2010305, 3rd Dec 2004
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Albendazole
Primary outcome measure	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 study start date	01/04/2005
Completion date	30/06/2006

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	Both
Target number of participants	1600
Key inclusion criteria	All primary and secondary school children (age 6-15) in four communes in Khanh Hoa province, central Viet Nam
Key exclusion criteria	Known allergy to Albendazole
Date of first enrolment	01/04/2005
Date of final enrolment	30/06/2006

Locations

Countries of recruitment

Viet Nam

Study participating centre

Oxford University Clinical Research Unit

Ho Chi Minh City
Viet Nam

Sponsor information

University of Nottingham (UK)
University/education

Centre for Population Sciences and Centre for Respiratory Research
Institute of Clinical Research
University of Nottingham
Nottingham
NG7 2RD
England
United Kingdom

Email	j.britton@virgin.net
Website	http://www.nottingham.ac.uk/icr/
"ROR"	https://ror.org/01ee9ar58

Funders

Funder type

Charity

Asthma UK (UK)
Private sector organisation / Other non-profit organizations

Alternative name(s): Asthma UK, Asthma + Lung UK
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan