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NCT02568579 · ClinicalTrials.gov registry record
Infant Immunity Comparison of Breastfed and Bottlefed Infants
A clinical trial, sponsored by Duke University.
- Completed
- Registry status
- 85
- Enrollment target
NCT02568579: Completed study, sponsored by Duke University.
NCT02568579 is a clinical trial that has completed, run by Duke University. The registered enrollment target is 85 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02568579 has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- 85 participants
- Enrollment target
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.
Primary Outcome
B cell priming and immunoglobulin diversity following immunizations at 2 and 4 month of age by modulating the microbial colonization of infant gut by pyrosequencing by using isotype specific primers.
Interventions
- PROCEDURE blood sample/ stool sample
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2015-01 |
| Est. Completion | 2017-12 |
What the finished NCT02568579 record still lists
NCT02568579 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 85 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which blood sample/ stool sample is the first listed.
NCT02568579 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02568579 about?
NCT02568579 is a clinical study titled "Infant Immunity Comparison of Breastfed and Bottlefed Infants". 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 ...
What is the current status of trial NCT02568579?
This trial is currently completed. The enrollment target is 85 participants. The study started on 2015-01. Estimated completion is 2017-12.
What interventions are being tested in trial NCT02568579?
The interventions under investigation include: blood sample/ stool sample (PROCEDURE).
Who is sponsoring clinical trial NCT02568579?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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