Infant Immunity Comparison of Breastfed and Bottlefed Infants

Completed

• Conditions: Infant Immunity Response and Immunoglobulin Diversity
• Interventions: Procedure: blood sample/ stool sample

• Registration Number: NCT02568579
• Lead Sponsor: Duke University

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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-09-15
• Study First Submitted QC: 2015-10-02
• Study First Posted: 2015-10-06
• Status Verified: 2017-06
• Primary Completion: 2017-11
• Study Completion: 2017-12
• Last Update Submitted: 2018-01-25
• Last Update Posted: 2018-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 85

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breastfed	blood sample/ stool sample	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
Bottlefed	blood sample/ stool sample	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.

Primary Outcome Measures

Name	Time	Method
Molecular profile of human IgG and IgA by pyrosequencing.	12 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

UNC Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States