Skip to main content
OpenTrials
Completed

NCT Number: NCT02568579

Infant Immunity Comparison of Breastfed and Bottlefed 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Children's Hospital Los Angeles, Los Angeles, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sample/ stool sample

Procedure

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

Primary outcomes

  1. Molecular profile of human IgG and IgA by pyrosequencing.

    Time frame: 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 outcomes

  1. Vaccine response

    Time frame: 12 months

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

  2. Antibody activity

    Time frame: 12 months

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

  3. Plasma level of B cell activating factor and/or a proliferation-inducing ligand

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Children's Hospital Los Angeles
  • University of South Florida

Registry information

Official study title

Effects of Breastfeeding in Immunologic Priming in Young Infants

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 6, 2015
Registry last updated
Jan 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.