DOnor Milk to REpair the Full-term Infant MIcrobiome in Infants Born Via Cesarean Section.
Launched by UNIVERSITY OF CALGARY · Dec 11, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating the effects of donor human milk (DHM) compared to formula on the gut health of full-term infants who are born via cesarean section (C-section) and need extra feeding. The study aims to see if using DHM can help restore the balance of beneficial bacteria in the gut, which is important for the baby's immune system and overall health. Additionally, the trial will look at how these feeding options might impact the baby's growth and sleep, as well as the mothers’ feelings of depression, anger, and their confidence in breastfeeding.
To be eligible for this trial, mothers must have delivered their baby via C-section, plan to breastfeed, and be comfortable understanding English. They also need to agree to let their baby receive donor milk. Mothers who have significant health problems that could affect breastfeeding or growth, or who do not plan to breastfeed, will not be included. Participants can expect to be part of a study that helps researchers understand how different feeding choices might influence both the baby's and the mother’s health.
Gender
ALL
Eligibility 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
About University Of Calgary
The University of Calgary is a leading research institution dedicated to advancing health and science through innovative clinical trials. With a strong emphasis on multidisciplinary collaboration, the university's clinical research initiatives aim to address pressing health challenges and improve patient outcomes. The institution fosters a robust environment for academic inquiry, leveraging state-of-the-art facilities and a diverse network of experts in various fields. Committed to ethical research practices and community engagement, the University of Calgary strives to translate scientific discoveries into tangible benefits for society.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Calgary, Alberta, Canada
Patients applied
Trial Officials
Meredith Brockway, PhD
Principal Investigator
University of Calgary
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported