Donor Milk for Infant Microbiome

(DO-RE-MI C-S Trial)

Overseen By Jannette Festival, BN

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Congenital malformation, No breastfeeding intention

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether donor human milk (DHM) benefits full-term infants born via c-section by improving gut health compared to formula. The focus is on DHM's impact on the infant's microbiome, which plays a crucial role in overall health, sleep, and growth. Researchers aim to determine if DHM helps mothers by reducing feelings of depression and anger and boosting confidence in breastfeeding. Mothers who have had a c-section, plan to breastfeed, and agree to DHM supplementation for their babies might be suitable for this study. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research on infant and maternal health.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that donor human milk is safe for full-term infants?

Research shows that donor human milk (DHM) is generally safe for babies. Studies with premature infants have found that DHM helps maintain a healthy balance of gut bacteria, crucial for digestion and overall health. A large review of donor milk samples found that most samples passed safety checks, indicating they were free from harmful bacteria. This suggests DHM is a well-tolerated option for babies needing extra milk. While more research is needed for full-term infants, existing studies with premature babies suggest DHM is a safe choice for feeding infants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using donor human milk (DHM) for newborns because it's packed with beneficial bacteria that can help shape a healthy infant microbiome, unlike standard infant formula. While formula provides essential nutrients, it lacks the live bacteria and bioactive components found in breast milk that are crucial for developing a strong gut and immune system. The unique composition of DHM supports better digestive health and could potentially reduce the risk of infections and other health issues in newborns, offering a promising alternative to traditional formula feeding.

What evidence suggests that donor human milk is effective for improving the infant gut microbiome?

Research has shown that donor human milk (DHM), which participants in this trial may receive, can promote a healthier gut in infants compared to formula. This benefit is particularly significant for babies born by c-section, as they miss exposure to beneficial bacteria during birth. Studies indicate that DHM supports gut health, which is crucial for the immune system and overall well-being. While most research has focused on premature babies, DHM might also benefit full-term babies by improving sleep and growth. Additionally, mothers may experience less depression and increased confidence in breastfeeding when using DHM. Overall, DHM could serve as a promising alternative to formula for supporting the health of both infants and mothers. ^{3 5 6 7 8}

Who Is on the Research Team?

Meredith Brockway, PhD

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

This trial is for full-term infants born via cesarean section who need extra feeding, and their mothers. It aims to see if donor human milk (DHM) can help develop a healthy gut microbiome compared to formula. Mothers must be willing to potentially use DHM or formula as supplements.

Inclusion Criteria

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.

Gestation greater than 37 weeks gestation (full-term)

Caesarean Section delivery

Exclusion Criteria

No intention to breastfeed

Diagnosed with clinically significant major congenital malformation that will interfere with breastfeeding or growth

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Intervention

Infants receive either Donor Human Milk (DHM) or formula supplementation for the first 7 days of life

1 week

Daily monitoring (in-person)

Follow-up

Participants are monitored for microbiome changes, growth, sleep, and maternal outcomes

6 months

3 visits (in-person) at 1 week, 3 months, and 6 months postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Donor Human Milk

Trial Overview The study tests whether DHM supplementation instead of formula can better establish the infant's gut microbiome after c-section birth. It also looks at how this affects infant sleep, growth, and maternal mental health outcomes like depression and breastfeeding success.

How Is the Trial Designed?

Group I: Donor Human Milk Experimental Treatment 1 Intervention

Infants randomized to the intervention group will receive DHM each time supplementation is required for the first 7 days of life.

Group II: Standard Care (Infant Formula) Active Control 1 Intervention

Infants randomized to the standard care group will receive formula each time supplementation is required for the first 7 days of life.

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

NorthernStar Mothers Milk Bank

Collaborator

Trials

2

Recruited

200+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

University of Victoria

Collaborator

Trials

59

Recruited

12,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11977380/

Impact of mother's own milk vs. donor human milk on gut ... This systematic review focuses on the effects of predominant DHM vs. MOM feeding on the gut microbiota composition in preterm infants.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40207271/

Impact of mother's own milk vs. donor human milk on gut ... This systematic review focuses on the effects of predominant DHM vs. MOM feeding on the gut microbiota composition in preterm infants.

3. publications.aap.org publications.aap.org/hospitalpediatrics/article/15/7/616/202055/Examination-of-Donor-Human-Milk-Practices-Within

Examination of Donor Human Milk Practices Within Well ... The aim of this study was to evaluate access to pasteurized donor human milk (PDHM) among neonatal intensive care units (NICUs) and well newborn nurseries ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02573779

Growth and Microbiome Development in Very Low Birth ... Background: Human milk feeding provides numerous benefits to preterm infants due to improvements in gastrointestinal maturation, host defense, infection rates, ...

5. journals.sagepub.com journals.sagepub.com/doi/full/10.1177/08903344251369442

Comparing Impacts of Donor Human Milk to Formula ... This study will generate essential data on the association between supplementation types and the full-term infant microbiome, breastfeeding ...

6. nature.com nature.com/articles/s41390-025-04386-2

Impact of donor human milk pasteurization methods on the ... We show that the type of pasteurization of donor human milk influences the gut microbiome and its function in preterm infants. In contrast to ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11243202/

Personalized Nutrition with Banked Human Milk for Early Gut ... Breast milk provides a more balanced and stable intestinal microbiota in babies [55], which in turn contributes to better intestinal tolerance ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0740002024001990

Microbiological analysis of donor human milk over seven ... A total of 6863 donor milk samples were subjected to microbiological screening, with 83.2% (n = 5707) passing and 16.8% (n = 1156) failing to meet the UK's ...