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ISRCTN
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ISRCTN41239086
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DOI
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10.1186/ISRCTN41239086
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Impact of maternal and infant geohelminth infections on atopy and vaccine immunity in infants living in rural tropical region of Ecuador [Impacto de las infecciones con geohelmintos en madres embarazadas e infantes sobre atopia e inmunidad a vacunas en infantes que viven en zonas rurales tropicales del Ecuador]
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Scientific title
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Impact of maternal and infant geohelminth infections on atopy and vaccine immunity in infants living in rural tropical region of Ecuador: a prospective birth cohort following up newborns to 5 years of age
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Acronym
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ECUAVIDA
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Serial number at source
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074679
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Study hypothesis
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Exposure to maternal geohelminth infections and infant geohelminth infections within the first 2 years of life:
1. Suppresses immune responses to childhood vaccines
2. Suppresses aeroallergen skin test reactivity
3. Protects against the development of eczema and asthma
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Lay summary
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Not provided at time of registration
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Ethics approval
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Ethics Committee of Hospital Pedro Vicente Maldonado, Pichincha Province, Ecuador, approved on the 13th June 2005
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Study design
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Observational; prospective birth cohort study
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Countries of recruitment
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Ecuador
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Disease/condition/study domain
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Vaccine immunity, allergic sensitisation, eczema, asthma
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Participants - inclusion criteria
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1. Neonate born within the previous 14 days
2. Gestational age of at least 34 weeks
3. At least one stool sample collected during third trimester of pregnancy
4. The mother lives within the geographic limits of the District of Quininde, Esmeraldas Province
5. The mother plans to live within the District of Quininde, Esmeraldas Province for at least 3 years
6. The mother's household is accessible
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Participants - exclusion criteria
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1. Neonate of greater than 14 days age
2. Gestational age less than 34 weeks
3. No stool sample collected during third trimester of pregnancy
4. The mother does not live within the geographic limits of the District of Quininde, Esmeraldas Province
5. The mother does not plan to live within the District of Quininde, Esmeraldas Province for at least 3 years
6. The mother's household is not easily accessible
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Anticipated start date
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01/12/2005
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Anticipated end date
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01/12/2015
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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2,500
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Interventions
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The primary exposures are maternal geohelminth infections and infant infections during the first 2 years of life. Stool samples are collected during pregnancy or at the time of birth to determine maternal infection status and at 3, 7, 13, 18, and 24 months to determine infant infection status. Stool samples are examined using a combination of methods including modified Kato-Katz method, formol-ether concentration, and carbon-coproculture. Observations for measurement of differences are made at 7, 13, 24, 36, and 60 months of age. Follow-up of all participants will be to 5 years of age.
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Primary outcome measure(s)
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1. Vaccine immunity: protective levels of antibodies to rotavirus, Hemophilus influenzae type B, hepatitis B virus, OPV serotype 3, and tetanus toxoid
2. Allergic sensitization: allergen skin test reactivity to at least one aeroallergen tested
3. Eczema: at least one presentation with eczema by 3 years of age
4. Asthma: Asthma diagnosed at 5 years of age
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Secondary outcome measure(s)
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Studies of intermediate immunological mechanisms that mediate exposure-outcome effects including:
1. Immune homeostasis: measured by spontaneous IL-10 in whole blood
2. Immune regulation/suppression - IL-10 to tetanus toxoid (TT), tuberculin (PPD), Ascaris lumbricoides or Dermatophagoides pteronyssinus
3. Th2 polarization - ratio of IL-5 to IFN-g TT, PPD or Staphylococcus enterotoxin B
4. Pro-inflammatory responses - IL-8 to endotoxin
These responses will be measured at 2, 3, or 5 years depending on the relevant exposure-outcome association.
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Sources of funding
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The Wellcome Trust (UK) (grant ref: 074679)
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Trial website
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Publications
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2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21714922
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Contact name
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Dr
Philip
Cooper
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Address
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Instituto de Microbiologia
Universidad san Francisco de Quito
Via interoceaniaca S/N
Cumbaya
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City/town
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Quito
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Zip/Postcode
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N/A
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Country
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Ecuador
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Sponsor
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Ecuadorian Foundation for Health Research (Fundacion Ecuatoriana Para Investigacion en Salud) (Ecuador)
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Address
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Gaspar de Villaroel y Shyris
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City/town
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Quito
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Zip/Postcode
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NA
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Country
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Ecuador
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Date applied
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30/04/2010
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Last edited
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26/02/2013
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Date ISRCTN assigned
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04/05/2010
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