Using donor milk to improve gut health in cesarean-born infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot randomized controlled trial aims to evaluate the effects of donor human milk (DHM) compared to formula supplementation on the gut microbiome of full-term infants born via cesarean section. The study will also assess health outcomes related to sleep and growth, as well as maternal outcomes such as depression and breastfeeding self-efficacy. By randomizing infants requiring supplementation, the study seeks to establish causal relationships between feeding type and microbiome development, enhancing the potential for implementing DHM in clinical practice. Conducted in a postpartum hospital setting, this research aims to provide pragmatic insights into the benefits of DHM for both infants and mothers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Gestation greater than 37 weeks gestation (full-term)
* Caesarean Section delivery
* Intending to breastfeed
* Consent for infant to receive DHM
* Working understanding (proficient in reading and understanding) of 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

Where it's running

• Rockeyview General Hospital
  Calgary, Alberta, Canada Recruiting

Study contacts

• Principal investigator: Meredith Brockway, PhD — University of Calgary
• Study coordinator: Meredith Brockway, PhD
• Email: mbrockwa@ucalgary.ca
• Phone: 403-689-0970

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.