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

105 Participants Needed

What You Need to Know Before You Apply

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.

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.

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. ^{1 2 3 4 5}

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. ^{4 6 7 8 9}

What data supports the effectiveness of the treatment Donor Human Milk for infant gut health?

Research shows that donor human milk can reduce the risk of serious gut problems like necrotizing enterocolitis and infections in premature infants. It is also preferred over formula because it offers significant health benefits, even though some properties are reduced during processing. ^{4 7 10 11 12}

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

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]

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 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. England pubmed.ncbi.nlm.nih.gov

Using donor human milk to feed vulnerable term infants: a case series in KwaZulu Natal, South Africa. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Human Milk Banking. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Human milk feeding and physical growth in very low-birth-weight infants: a multicenter study. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Outcomes improved with human milk intake in preterm and full-term infants. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Growth in VLBW infants fed predominantly fortified maternal and donor human milk diets: a retrospective cohort study. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

Donor human milk banking and the emergence of milk sharing. [2012]

8. United States pubmed.ncbi.nlm.nih.gov

Ensuring Safety in Donor Human Milk Banking in Neonatal Intensive Care. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Exploring the barriers and facilitators to the acceptability of donor human milk in eastern Uganda - a qualitative study. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Fetal Intestinal Cell Growth and Antimicrobial Biofunctionalities of Donor Human Milk After Preparative Processes. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Microbiological Screening of Donor Human Milk. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

The Current State of Donor Human Milk Use and Practice. [2021]