Infant Immunity Comparison of Breastfed and Bottlefed Infants

Duke University

Status: Completed

Conditions: Infant Immunity Response and Immunoglobulin Diversity

Treatments: Procedure: blood sample/ stool sample

Study type: Observational

Funder types: Other

Identifiers

NCT02568579

Pro00050219

Details and patient eligibility

About

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.

Full description

Cord Blood will be collected at birth if possible and peripheral blood will be collected at 6 month of age (5 to 10 days after receiving their standard 6 month immunizations) and at 12 months of age prior to their 12 month immunization. Additionally, stool samples will be collected within the first week of live and once monthly through 12 months of age. Breastfeeding mothers will collect breast milk once monthly at the same time as the stool specimen during the period of breastfeeding.

Enrollment: 85 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

85 participants in 2 patient groups

Breastfed

Description:

collection of blood/stool/breast milk samples and information about feeding changes and introduction of solid foods. - Cord Blood sample, stool samples monthly and blood sample at 6 month and 12 months of age

Treatment:

Procedure: blood sample/ stool sample

Bottlefed

Description:

collection of blood/stool samples and information about feeding changes and introduction of solid foods. Coord blood sample, stool samples monthly and blood sample at 6 month and 12 month of age.

Treatment:

Procedure: blood sample/ stool sample