Donor Human Milk for Infant Gut Health
(PPDHM Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are receiving extended courses of antibiotics beyond the IAP in labor, you would not be eligible to participate.
What data supports the effectiveness of the treatment Donor Human Milk for infant gut health?
Is donor human milk safe for infants?
Donor human milk is generally considered safe for infants, especially when mother's milk is unavailable. It is used in neonatal intensive care units and has been shown to reduce risks like necrotizing enterocolitis (a serious intestinal disease) and infections in premature babies. Safety is ensured through careful donor selection, pasteurization, and quality control measures.16789
How is donor human milk different from other treatments for infant gut health?
Donor human milk is unique because it provides essential nutrients and immune factors that promote infant health, and it is the best alternative when a mother's own breast milk is unavailable. Unlike formula, donor milk reduces the risk of serious conditions like necrotizing enterocolitis and sepsis, especially in premature infants, although its antimicrobial properties are somewhat reduced due to pasteurization.12101112
What is the purpose of this trial?
This trial is testing whether giving donor human milk instead of formula to full-term infants can help maintain healthy gut bacteria. The study aims to see if this can improve the babies' sleep, growth, and overall health. The trial also looks at how this affects the mothers' mental health and breastfeeding success.
Research Team
Meredith Brockway, PhD RN
Principal Investigator
University of Calgary
Eligibility Criteria
This trial is for full-term infants exposed to antibiotics during labor and their mothers who plan on breastfeeding. Eligible moms must understand English, agree to let their baby have donor milk, and be able to follow the study's rules. Babies with major birth defects affecting feeding or growth, or those needing long-term antibiotics beyond labor treatment can't join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Infants receive either donor human milk or formula supplementation for the first 7 days of life
Follow-up
Participants are monitored for microbiome diversity, growth, and maternal outcomes
Treatment Details
Interventions
- Donor Human Milk
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Calgary
Lead Sponsor
University of British Columbia
Collaborator
NorthernStar Mothers Milk Bank
Collaborator
University of Victoria
Collaborator