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Comparing Impacts of Donor Human Milk to Formula Supplementation on the Gut Microbiome of Full-term Infants

Microbial Colonization

The goal of this pilot randomized controlled trial (RCT) is to examine donor human milk (DHM) as a clinical intervention targeted at achieving beneficial microbiome signatures in full-term infants who are exposed to intrapartum antibiotic prophylaxis (IAP) therapy during labour. Secondarily, this study aims to compare the infant health outcomes of sleep and growth between groups to assess if these outcomes are mediated by infant feeding type or potential differences in microbial signatures. Finally, this study will compare maternal outcomes of depression, anger, breastfeeding self-efficacy and breastfeeding rates between groups.

The hypothesis of this study is: that replacing formula with DHM supplementation will minimize gut microbiome dysbiosis and foster homeostasis following supplementation. In addition, it is hypothesized that improved homeostasis will promote improved sleep and growth outcomes in participant infants. Finally, mothers whose infants receive DHM will have lower depression and anger scores and high breastfeeding self-efficacy and exclusive breastfeeding rates compared to mothers whose infants receive formula.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    37 and up

Participation Criteria

Inclusion Criteria:

* Gestation greater than 37 weeks (full-term)
* Completion of antibiotic protocol for GBS during labour
* Vaginal delivery
* Intending on breastfeeding
* Consent for infant to receive DHM
* Working understanding (proficient in reading and understanding) English
* Mother has provided signed and dated informed consent and authorization to use protected health information, as required by national and local regulations.
* In the investigator's opinion, the subject mother understands and can comply with protocol requirements, instructions, and protocol-stated restrictions, and is likely to complete the study as planned.

Exclusion Criteria:

* Diagnosed with clinically significant major congenital malformation that will interfere with breastfeeding or growth
* No intention to breastfeed
* Receiving extended courses of antibiotics (beyond that of the IAP in labour)

Study Location

Rockyview General Hospital
Rockyview General Hospital
Calgary, Alberta
Canada

Contact Study Team

Primary Contact

Dena Berci, MN

[email protected]
(403) 943-3109
Study Sponsored By
University of Calgary
Participants Required
More Information
Study ID: NCT05815433