## Protocol Section
### Identification Module
**NCT ID:** NCT02568579

**Brief Title:** Infant Immunity Comparison of Breastfed and Bottlefed Infants

**Official Title:** Effects of Breastfeeding in Immunologic Priming in Young Infants

#### Organization Study ID Info
**ID:** Pro00050219
#### Organization
**Class:** OTHER
**Full Name:** Duke University
### Status Module
#### Completion Date
**Date:** 2017-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-01-29

**Type:** ACTUAL

**Last Update Submit Date:** 2018-01-25

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-11

**Type:** ACTUAL

#### Start Date
**Date:** 2015-01

**Type:** ACTUAL

**Status Verified Date:** 2017-06

#### Study First Post Date
**Date:** 2015-10-06
**Type:** ESTIMATED
**Study First Submit Date:** 2015-09-15
**Study First Submit QC Date:** 2015-10-02
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University of South Florida

**Class:** OTHER

**Name:** Children's Hospital Los Angeles

#### Lead Sponsor

**Class:** OTHER

**Name:** Duke University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Infant Immunity Response and Immunoglobulin Diversity

### Design Module

#### Bio Spec

**Description:** Four 2.6 ml ACD tubes will be collected . All blood will be processed for pyrosequencing, TBNK, CBC and differential, platelets, sera plasman and PBMC's. Stool samples

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 85

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**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

**Intervention Names:**

- Procedure: blood sample/ stool sample

**Label:** Breastfed

#### Arm Group 2

**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.

**Intervention Names:**

- Procedure: blood sample/ stool sample

**Label:** Bottlefed

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Bottlefed

- Breastfed

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

**Name:** blood sample/ stool sample

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Molecular profile of human IgG and IgA by pyrosequencing.

**Time Frame:** 12 months

#### Secondary Outcomes

**Description:** post immunization antibody titers (via ELISA) to Hib, tetanus, diphtheria, pertussis and pneumococcal polysaccharide serotypes contained in the Prevnar 13 vaccine.

**Measure:** Vaccine response

**Time Frame:** 12 months

**Description:** Functional activity of antibodies measured by opsonophagocytic activity to Pneumococcal and Hib vaccine

**Measure:** Antibody activity

**Time Frame:** 12 months

**Description:** Degree of B cell differentiation and activation in B cell by BD bioscience Canto flow cytometry.

**Measure:** Plasma level of B cell activating factor and/or a proliferation-inducing ligand

**Time Frame:** 12 months

### Eligibility Module

**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

**Healthy Volunteers:** True

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

**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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Los Angeles

**Country:** United States

**Facility:** Children's Hospital Los Angeles

**State:** California

**Zip:** 90027

**Location 2:**

**City:** Chapel Hill

**Country:** United States

**Facility:** UNC Chapel Hill

**State:** North Carolina

**Zip:** 27514

**Location 3:**

**City:** Durham

**Country:** United States

**Facility:** Duke University Medical Center

**State:** North Carolina

**Zip:** 27710

#### Overall Officials

**Official 1:**

**Affiliation:** Duke University

**Name:** John Sleasman, MD

**Role:** STUDY_DIRECTOR

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
