Clinical trial NCT02568579: Infant Immunity Comparison of Breastfed and Bottlefed Infants
Official title: Effects of Breastfeeding in Immunologic Priming in Young Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant Immunity Response and Immunoglobulin Diversity
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of South Florida
name: Children's Hospital Los Angeles
First posted: 2015-10-06
Enrollment: 85
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * Pregnant women 18 years of age or older.
* Vaginal delivery
* Healthy, full-term babies.
* Willing to primarily (\> 75%) breastfeed or exclusively formula feed for at least the first 4 months of life.
* Willing to follow the American Academy of Pediatrics' Immunizations guidelines.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Molecular profile of human IgG and IgA by pyrosequencing.
timeFrame: 12 months
Secondary outcomes:
measure: Vaccine response
timeFrame: 12 months
measure: Antibody activity
timeFrame: 12 months
measure: Plasma level of B cell activating factor and/or a proliferation-inducing ligand
timeFrame: 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Chapel Hill
country: United States
facility: UNC Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: John Sleasman, MD
role: STUDY_DIRECTOR
References: