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]

Not Applicable

Completed

• Conditions: Vaccine immunity, allergic sensitisation, eczema, asthma; Not Applicable; Immunisation

• Registration Number: ISRCTN41239086
• Lead Sponsor: Ecuadorian Foundation for Health Research (Fundacion Ecuatoriana Para Investigacion en Salud) (Ecuador)

Brief Summary

2011 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/21714922 protocol 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26908751 results 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33745189/ (added 22/03/2021) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33257440/ childhood wheeze cross-sectional analysis (added 27/10/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-05-04
• Study Completion: 2015-12-01
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2500

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Vaccine immunity: protective levels of antibodies to rotavirus, Hemophilus influenzae type B, hepatitis B virus, OPV serotype 3, and tetanus toxoid<br> 2. Allergic sensitization: allergen skin test reactivity to at least one aeroallergen tested<br> 3. Eczema: at least one presentation with eczema by 3 years of age<br> 4. Asthma: Asthma diagnosed at 5 years of age<br>

Secondary Outcome Measures

Name	Time	Method
<br> Studies of intermediate immunological mechanisms that mediate exposure-outcome effects including:<br> 1. Immune homeostasis: measured by spontaneous IL-10 in whole blood<br> 2. Immune regulation/suppression - IL-10 to tetanus toxoid (TT), tuberculin (PPD), Ascaris lumbricoides or Dermatophagoides pteronyssinus<br> 3. Th2 polarization - ratio of IL-5 to IFN-g TT, PPD or Staphylococcus enterotoxin B<br> 4. Pro-inflammatory responses - IL-8 to endotoxin<br><br> These responses will be measured at 2, 3, or 5 years depending on the relevant exposure-outcome association.<br>