Infant Immunity Comparison of Breastfed and Bottlefed Infants

Effects of Breastfeeding in Immunologic Priming in Young 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 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.

Study Overview

• Status: Completed
• Conditions: Infant Immunity Response and Immunoglobulin Diversity
• Intervention / Treatment: Procedure: blood sample/ stool sample

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.

• Study Type: Observational
• Enrollment (Actual): 85

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hospital Los Angeles
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • UNC Chapel Hill
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Breastfed; 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	Procedure: blood sample/ stool sample; blood sample to be done when possible with standard of care lab draw. Stool sample to be collected monthly at home.
Bottlefed; 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.	Procedure: blood sample/ stool sample; blood sample to be done when possible with standard of care lab draw. Stool sample to be collected monthly at home.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Molecular profile of human IgG and IgA by pyrosequencing.	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaccine response	post immunization antibody titers (via ELISA) to Hib, tetanus, diphtheria, pertussis and pneumococcal polysaccharide serotypes contained in the Prevnar 13 vaccine.	12 months
Antibody activity	Functional activity of antibodies measured by opsonophagocytic activity to Pneumococcal and Hib vaccine	12 months
Plasma level of B cell activating factor and/or a proliferation-inducing ligand	Degree of B cell differentiation and activation in B cell by BD bioscience Canto flow cytometry.	12 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: University of South Florida; Children's Hospital Los Angeles
• Investigators: Study Director: John Sleasman, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: September 15, 2015
• First Submitted That Met QC Criteria: October 2, 2015
• First Posted (Estimate): October 6, 2015

Study Record Updates

• Last Update Posted (Actual): January 29, 2018
• Last Update Submitted That Met QC Criteria: January 25, 2018
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: Pro00050219

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No