Comparing impacts of donor human milk to formula supplementation on the gut microbiome of full-term infants born via cesarean section: Protocol for a pilot randomized controlled trial

Simple item page
dc.contributor.authorBrockway, Meredith
dc.contributor.authorKhalid, Maria
dc.contributor.authorKhalil, Yasmeen
dc.contributor.authorRusi, Heather
dc.contributor.authorAsbury, Michelle R.
dc.contributor.authorArrieta, Marie-Claire
dc.contributor.authorKeys, Elizabeth
dc.contributor.authorOu, Christine
dc.contributor.authorFestival, Jannette
dc.date.accessioned2026-05-07T17:31:17Z
dc.date.available2026-05-07T17:31:17Z
dc.date.issued2025
dc.description.abstractBackground: A disrupted gut microbiome during an infant’s first 1000?days of life can lead to long-lasting negative effects on child health. Cesarean delivery and formula feeding are two factors that can detrimentally impact infant microbiome development as well as maternal mental health. Donor human milk may be a superior supplementation alternative to formula. Research Aim: To examine donor human milk supplementation compared to formula supplementation in full-term infants born via Cesarean section and the impact on the infant gut microbiome, infant health outcomes, breastfeeding outcomes, and maternal mental health. Methods and Planned Analyses: We are conducting a pilot clinical randomized controlled trial, comparing donor human milk to formula supplementation for 187 full-term infants born via Cesarean section who are breastfeeding and require supplementation in the first postnatal week of life. Infant stool samples, breastfeeding outcomes, maternal mental health, and child health outcomes will be measured at 1-week, 3-, 6-, and 12-months postpartum. Additionally, child health and maternal mental health are being assessed at 18- and 36-months postpartum. Discussion: This study will generate essential data on the association between supplementation types and the full-term infant microbiome, breastfeeding exclusivity and duration, and infant health. It will also provide preliminary data to inform a multi-site, longitudinal mixed-methods randomized controlled trial that will assess longer term child health outcomes. This evidence may be used to inform guidelines and policies that will increase accessibility to and raise awareness of donor human milk as a supplementation option in this population
dc.description.reviewstatusReviewed
dc.description.scholarlevelFaculty
dc.description.sponsorshipThe authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was supported by funding from the Canadian Institutes of Health Research (CIHR), the Alberta Registered Nurses Educational Trust and the University of Calgary.
dc.identifier.citationBrockway, M., Khalid, M., Khalil, Y., Rusi, H. C., Asbury, M. R., Arrieta, M., Keys, E., Ou, C., & Festival, J. (2025). Comparing impacts of donor human milk to formula supplementation on the gut microbiome of Full-Term infants born via cesarean section: Protocol for a pilot randomized controlled trial. Journal of Human Lactation, 41(4), 575–586. https://doi.org/10.1177/08903344251369442
dc.identifier.urihttps://doi.org/10.1177/08903344251369442
dc.identifier.urihttps://hdl.handle.net/1828/23828
dc.language.isoen
dc.publisherJournal of Human Lactation
dc.rightsCC BY-NC
dc.rights.urihttps://creativecommons.org/licenses/by-nc/4.0/
dc.subjectSexual and Reproductive Health and Rights (SRHR) Aspiration Research Cluster
dc.subjectbreastfeeding
dc.subjectCaesarean section
dc.subjectdonor human milk
dc.subjectexclusive breastfeeding
dc.subjectformula feeding
dc.subjectfull-term infant
dc.subjectgastrointestinal microbiome
dc.subjectmaternal mental health
dc.subjectrandomized controlled trials
dc.subjectSexual and Reproductive Health and Rights (SRHR) Aspiration Research Cluster
dc.subject.departmentSchool of Nursing
dc.titleComparing impacts of donor human milk to formula supplementation on the gut microbiome of full-term infants born via cesarean section: Protocol for a pilot randomized controlled trial
dc.typeArticle

Files

Original bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
brockway_jHumLact_2025.pdf
Size:
570.24 KB
Format:
Adobe Portable Document Format
Download

Collections

SRHR Aspiration Research Cluster Publications
 
University of Victoria Libraries

We acknowledge and respect the Lək̓ʷəŋən (Songhees and Esquimalt) Peoples on whose territory the university stands, and the Lək̓ʷəŋən and W̱SÁNEĆ Peoples whose historical relationships with the land continue to this day.