Condition category
Infections and Infestations
Date applied
17/12/2005
Date assigned
21/12/2005
Last edited
21/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Philip Cooper

ORCID ID

Contact details

Hospital Pedro Vicente Maldonado
Casilla 17-14-30
Carcelen
Quito
-
Ecuador
+593 (0)2 2470181
pcooper@ecnet.ec

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

060120

Study information

Scientific title

Acronym

Study hypothesis

Geohelminth infections suppress atopy in children and this suppression is reversible by anthelmintic treatment.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Geohelminth infections

Intervention

Bimonthly albendazole (400 mg) for 12 months (total of seven treatments) versus no intervention.

Intervention type

Drug

Phase

Not Specified

Drug names

Albendazole

Primary outcome measures

Atopy (measured by allergen skin test reactivity)

Secondary outcome measures

1. Allergic symptoms
2. Exercise-induced bronchospasm
3. Flexural dermatitis

Overall trial start date

15/06/2002

Overall trial end date

01/09/2004

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

68 schools; ~2,730 children

Participant 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

Recruitment start date

15/06/2002

Recruitment end date

01/09/2004

Locations

Countries of recruitment

Ecuador

Trial participating centre

Hospital Pedro Vicente Maldonado
Quito
-
Ecuador

Sponsor information

Organisation

St George's Hospital Medical School (UK)

Sponsor details

Cranmer Terrace
London
SW17 ORE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.sgul.ac.uk

Funders

Funder type

Charity

Funder name

The Wellcome Trust (UK) (grant ref: 060120)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results in http://www.ncbi.nlm.nih.gov/pubmed/16698413

Publication citations

  1. Results

    Cooper PJ, Chico ME, Vaca MG, Moncayo AL, Bland JM, Mafla E, Sanchez F, Rodrigues LC, Strachan DP, Griffin GE, Effect of albendazole treatments on the prevalence of atopy in children living in communities endemic for geohelminth parasites: a cluster-randomised trial., Lancet, 2006, 367, 9522, 1598-1603, doi: 10.1016/S0140-6736(06)68697-2.

Additional files

Editorial Notes