Infant Immunity Comparison of Breastfed and Bottlefed Infants

Completed

Conditions studied: Infant Immunity Response and Immunoglobulin Diversity

In brief

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.

Key facts

Study ID

NCT02568579

Run by

Duke University

People needed

85

Starts

2015-01-01

Expected to finish

2017-12-01

Last updated by the study team

2018-01-29

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Self-declared pregnant woman
• Age 18 years or older at the time of consent
• Willing and able to sign consent and follow study schedule
• Planned vaginal delivery
• Willing to primarily breastfed or formula feed for the first four months

You may not qualify if…

• Planned delivery by C-Section
• Unwillingness to exclusively breast feed or formula feed their infant for at least the first 4 months
• Unwillingness to receive standard immunizations on the schedule recommended by the American Academy of Pediatrics
• Chronic maternal condition that may influence infant immunity including but not limited to: maternal HIV, immunodeficiency, use of immunosuppressive medications, malignancy or autoimmunity
• Known fetal medical conditions such as congenital malformations
• Use of immune modulating/immune suppressive medication and prophylactic antibiotics during pregnancy
• Any condition that may prevent a mother who plans to breast feed from breast feeding
• Any condition that in the opinion of the investigator would interfere with the conduct of the study

Where it is running

• Children's Hospital Los Angeles — Los Angeles, California, United States
• UNC Chapel Hill — Chapel Hill, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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