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A cluster-randomised study of the effect of albendazole treatment on the prevalence of childhood atopy among children with geohelminth infections
ISRCTN ISRCTN61195515
DOI 10.1186/ISRCTN61195515
ClinicalTrials.gov identifier
EudraCT number
Public title A cluster-randomised study of the effect of albendazole treatment on the prevalence of childhood atopy among children with geohelminth infections
Scientific title
Acronym N/A
Serial number at source 060120
Study hypothesis Geohelminth infections suppress atopy in children and this suppression is reversible by anthelmintic treatment.
Lay summary Not provided at time of registration
Ethics approval Approval received from:
1. St George's Hospital London (UK) 2002
2. Hospital Pedro Vicente Maldonado (Ecuador) 2002
Study design Cluster-randomised trial
Countries of recruitment Ecuador
Disease/condition/study domain Geohelminth infections
Participants - inclusion criteria Schools:
1. Access during rainy season
2. Total size less than 150 children
3. Preliminary meetings attended by a majority of parents

Individuals:
1. Healthy children in second to seventh year of primary education (i.e. aged eight to 14 years)
2. Informed written consent by a parent
Participants - exclusion criteria Schools:
1. Limited access during rainy season
2. Total size more than 150 children
3. Preliminary meetings attended by minority of parents

Individuals:
1. Children not in second to seventh year of primary education
2. No informed written consent by a parent
Anticipated start date 15/06/2002
Anticipated end date 01/09/2004
Status of trial Completed
Patient information material
Target number of participants 68 schools; ~2,730 children
Interventions Bimonthly albendazole (400 mg) for 12 months (total of seven treatments) versus no intervention.
Primary outcome measure(s) Atopy (measured by allergen skin test reactivity)
Secondary outcome measure(s) 1. Allergic symptoms
2. Exercise-induced bronchospasm
3. Flexural dermatitis
Sources of funding The Wellcome Trust (UK) (grant ref: 060120)
Trial website
Publications Results in http://www.ncbi.nlm.nih.gov/pubmed/16698413
Contact name Dr  Philip  Cooper
  Address Hospital Pedro Vicente Maldonado
Casilla 17-14-30
Carcelen
  City/town Quito
  Zip/Postcode -
  Country Ecuador
  Tel +593 (0)2 2470181
  Email pcooper@ecnet.ec
Sponsor St George's Hospital Medical School (UK)
  Address Cranmer Terrace
  City/town London
  Zip/Postcode SW17 ORE
  Country United Kingdom
  Sponsor website: http://www.sgul.ac.uk
Date applied 17/12/2005
Last edited 21/03/2013
Date ISRCTN assigned 21/12/2005
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