Donor Human Milk for Infant Gut Health

(PPDHM Trial)

Overseen By Jannette Festival, BN

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Must not be taking: Extended antibiotics

Disqualifiers: Major congenital malformation, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether donor human milk (DHM) can improve gut health in full-term infants whose mothers received antibiotics during labor. Researchers aim to determine if DHM leads to better sleep, growth, and overall health compared to formula. They are also examining how DHM might influence the mothers' mood and breastfeeding success. Mothers who delivered a full-term baby vaginally and plan to breastfeed may qualify for this trial. As an unphased study, this trial provides a unique opportunity to contribute to groundbreaking research that could enhance infant and maternal health.

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 prior data suggests that donor human milk is safe for infant gut health?

Research shows that donor human milk (DHM) is generally safe for babies. One study found that pasteurized DHM contains a similar mix of bacteria to that in breastfed babies, suggesting infants tolerate it well.

Another study of over 6,800 DHM samples found that most had healthy levels of bacteria, indicating the milk is usually safe for babies to drink. DHM also supports healthy gut bacteria and good digestion in babies.

While donor milk differs from a mother's own milk, it is often used when breastfeeding isn't possible. It is considered a safe option for supporting a baby's health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using donor human milk (DHM) for infant gut health because it offers a natural and potentially superior alternative to standard infant formula. Unlike formula, which is a manufactured product, DHM is derived from breast milk donated by other mothers, providing essential nutrients and antibodies that can be crucial for a newborn's development. This unique composition may help improve gut health and strengthen the immune system in ways that formula cannot. By using DHM, researchers hope to tap into the natural benefits of human milk, potentially leading to better outcomes for infants needing supplementation.

What evidence suggests that donor human milk is effective for infant gut health?

Research shows that donor human milk (DHM), which participants in this trial may receive, benefits a baby's gut health. Studies have found that DHM fosters a healthier mix of gut bacteria, crucial for digestion and overall health. Compared to formula, the standard care in this trial, DHM may reduce gut problems and support a stable gut environment. This stability might also improve sleep and growth in babies. Additionally, mothers whose babies consume DHM might experience better emotional well-being and find breastfeeding easier. Overall, early evidence suggests DHM can be a helpful alternative to formula for newborns. ^{1 2 6 7 8}

Who Is on the Research Team?

Meredith Brockway, PhD RN

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

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

Vaginal delivery

Gestation greater than 37 weeks (full-term)

Completion of antibiotic protocol for GBS during labour

Exclusion Criteria

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

No intention to breastfeed

I am on a long-term antibiotic treatment.

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 or formula supplementation for the first 7 days of life

1 week

Daily monitoring (in-person)

Follow-up

Participants are monitored for microbiome diversity, growth, and maternal outcomes

12 weeks

3 visits (in-person) at 1, 6, and 12 weeks postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Donor Human Milk

Trial Overview The study tests if using donated human milk instead of formula helps develop a healthier gut in babies given antibiotics at birth. It also looks at whether this affects infant sleep and growth, as well as maternal mood, confidence in breastfeeding, and rates of exclusive breastfeeding.

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+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

NorthernStar Mothers Milk Bank

Collaborator

Trials

2

Recruited

200+

University of Victoria

Collaborator

Trials

59

Recruited

12,000+

Published Research Related to This Trial

Human milk has been shown to significantly benefit both preterm and term infants, including those with serious health conditions, by promoting gut health, growth, and neurocognitive development.

Research indicates that specific human milk diets can lower the risk of certain diseases, and ongoing studies aim to enhance donor human milk products to improve outcomes for infants who cannot receive their own mother's milk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes improved with human milk intake in preterm and full-term infants. Chetta, KE., Schulz, EV., Wagner, CL.[2022]

Donor human milk is recommended by the World Health Organization for infant feeding when mother's milk is unavailable, and it has been shown to improve health outcomes in low birthweight infants by reducing serious conditions like necrotising enterocolitis and late onset sepsis.

In a series of seven case studies involving orphaned and abandoned children, many HIV exposed or positive, the use of pasteurized donor human milk showed potential protective effects against failure to thrive, diarrhea, atopic dermatitis, and opportunistic infections, despite limited medical records.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using donor human milk to feed vulnerable term infants: a case series in KwaZulu Natal, South Africa. Reimers, P., Shenker, N., Weaver, G., et al.[2023]

Donor human milk can provide therapeutic benefits to infants, but its use should be based on a careful assessment of the benefits versus known risks, which can vary based on donor selection and processing methods.

High ethical standards are essential in the collection and use of donor human milk to ensure the safety of both donors and recipients, and any supplementation should be done cautiously to avoid interfering with maternal breastfeeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefit by design: Determining the 'value' of donor human milk and medical products derived from human milk in NICU. Hartmann, BT.[2020]

Donor human milk is considered a safe and effective alternative for feeding extremely preterm infants when their mother's milk is not available, supported by clinical data on its benefits.

The article proposes a risk assessment methodology for milk banks worldwide to evaluate and enhance the safety of their processes, ensuring quality control in donor selection and pasteurization techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Donor human milk banking and the emergence of milk sharing. Landers, S., Hartmann, BT.[2012]

Citations

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

Impact of donor human milk pasteurization methods on the ... In conclusion, our data suggest that the type of DHM pasteurization affects the composition of the intestinal microbiome and its functional ...

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. clinicaltrials.gov clinicaltrials.gov/study/NCT06177184

DOnor Milk to REpair the Full-term Infant MIcrobiome in ... The hypothesis of this study is: that replacing formula with DHM supplementation will minimize gut microbiome dysbiosis and foster homeostasis following ...

4. 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.

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. web.musc.edu web.musc.edu/about/news-center/2025/09/24/donor-milk-storage

How donor human milk storage affects preemie gut health “Our results showed that babies weren't as protected with the use of donor milk that was stored for a longer time as with donor milk that was ...

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

Microbiological analysis of donor human milk over seven ... An analysis of 6863 DHM samples from 1419 donors at the Hearts Milk Bank between 2017 and 2023 showed approximately 70.1% of samples exhibited a total viable ...

8. cureus.com cureus.com/articles/233098-unlocking-the-potential-a-systematic-literature-review-on-the-impact-of-donor-human-milk-on-infant-health-outcomes

Unlocking the Potential: A Systematic Literature Review on ... It has been shown that a healthy consumption of human milk influences the composition of gut bacteria, stimulates the gastrointestinal mucosa, ...