Status:
RECRUITING
DOnor Milk to REpair the Full-term Infant MIcrobiome in Infants Born Via Cesarean Section.
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
University of British Columbia
University of Victoria
Conditions:
Microbial Colonization
Eligibility:
All Genders
37+ years
Phase:
NA
Brief Summary
The objective of this novel study is to establish proof of concept using a pilot randomized controlled trial to determine the effect of DHM compared to formula supplementation on the microbiome in ful...
Detailed Description
Investigators propose to conduct a pilot clinical RCT in the postpartum hospital setting examining DHM as an intervention provided to full-term infants delivered via caesarean section. Randomization o...
Eligibility Criteria
Inclusion
- 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
- Diagnosed with clinically significant major congenital malformation that will interfere with breastfeeding or growth
- No intention to breastfeed
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06177184
Start Date
October 1 2024
End Date
December 31 2026
Last Update
March 27 2025
Active Locations (1)
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1
Rockeyview General Hospital
Calgary, Alberta, Canada, T2V1P9