Using donor milk to improve gut health in cesarean-born infants
DOnor Milk to REpair the Full-term Infant MIcrobiome in Infants Born Via Caesarean Section
This study is trying to see if giving cesarean-born babies donor human milk instead of formula can help their gut health and improve sleep and growth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 37 Weeks and up |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT06177184 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are full-term infants born via cesarean section whose mothers intend to breastfeed.
Not a fit: Patients who do not intend to breastfeed or have significant congenital malformations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the gut health and overall well-being of infants born via cesarean section.
How similar studies have performed: While the use of donor human milk is gaining attention, this specific approach in cesarean-born infants is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Calgary, Alberta
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.