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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]

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN41239086
Enrollment
2500
Registered
2010-05-04
Start date
2005-12-01
Completion date
Unknown
Last updated
2021-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaccine immunity, allergic sensitisation, eczema, asthma Not Applicable Immunisation

Interventions

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 mate

Sponsors

Ecuadorian Foundation for Health Research (Fundacion Ecuatoriana Para Investigacion en Salud) (Ecuador)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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.

Countries

Ecuador

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 28, 2026