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Infant Immunity Comparison of Breastfed and Bottlefed Infants

NCT02568579 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 85

Last updated 2018-01-29

No results posted yet for this study

Summary

This study will follow 40 healthy, vaginally delivered infants that are primarily (\>/- 75%) breast fed and 40 infants that are exclusively formula fed for at least the first 4 months of life from birth until 12 month age. Visits - Subjects will be consented prior to delivery, visit 1. Subject will be seen if possible after delivery for instruction on stool collection and distribution of supplies, visit 2. Subject will be seen at 6 months of age post immunization, visit 3. Subject will be seen prior to 12 month visit. Study staff will contact via phone/email to collect information about feeding changes.

Conditions

  • Infant Immunity Response and Immunoglobulin Diversity

Interventions

PROCEDURE

blood sample/ stool sample

blood sample to be done when possible with standard of care lab draw. Stool sample to be collected monthly at home.

Sponsors & Collaborators

Principal Investigators

  • John Sleasman, MD · Duke University

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2017-11-30
Completion
2017-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02568579 on ClinicalTrials.gov