Does the eradication of endoparasites promote allergic disease?
| ISRCTN | ISRCTN71058787 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71058787 |
| Protocol serial number | N/A |
| Sponsor | University of Nottingham (UK) |
| Funder | Asthma UK (UK) |
- 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
Scientific
Oxford University Clinical Research Unit
Hospital for Tropical Diseases
Ho Chi Minh City
Viet Nam
| flohr@dng.vnn.vn |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double blind randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Albendazole |
| Primary outcome measure(s) |
Change in percent fall in peak expiratory flow after exercise challenge post gut worm treatment |
| Key secondary outcome measure(s) |
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 |
| Completion date | 30/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 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
Viet Nam
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
