NCT02568579|Completed
Infant Immunity Comparison of Breastfed and Bottlefed Infants
Effects of Breastfeeding in Immunologic Priming in Young Infants
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Effects of Breastfeeding in Immunologic Priming in Young Infants
Sponsor study identifier
observational
85
1 country
3
Study Start
January 2015
Actual (reported)Primary Completion
November 2017
Actual (reported)Study Completion
December 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2015
Actual (reported)September 15, 2015
Actual (reported)October 6, 2015
Actual (reported)November 2017
Actual (reported)December 2017
Actual (reported)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
Vaccine response
12 months
Antibody activity
12 months
Plasma level of B cell activating factor and/or a proliferation-inducing ligand
12 months
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
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.
blood sample to be done when possible with standard of care lab draw. Stool sample to be collected monthly at home.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
* 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.
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
UNC Chapel Hill
Chapel Hill, North Carolina, 27514, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Yin L, Venturi GM, Barfield R, Fischer BM, Kim-Chang JJ, Chan C, De Paris K, Goodenow MM, Sleasman JW. Maternal immunity shapes biomarkers of germinal center development in HIV-exposed uninfected infants. Front Immunol. 2024 Sep 12;15:1443886. doi: 10.3389/fimmu.2024.1443886. eCollection 2024.
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
John Sleasman, MD
Duke University
85 participants (actual enrollment reported by the registry).
First Submitted
September 15, 2015
First Posted
October 6, 2015
Study Start
January 2015
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
November 2017
Actual (reported)Study Completion
December 2017
Actual (reported)Last Updated
January 29, 2018
Record last verified: 2017-06
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Source: ClinicalTrials.gov.
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