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

Trial Summary

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 data supports the effectiveness of the treatment Donor Human Milk for the infant microbiome?

Donor human milk is considered the best alternative when a mother's own milk is not available, as it still provides some benefits for infant gut health. Although donor milk may have reduced antimicrobial activity due to pasteurization, it still contains beneficial components that can influence the infant's gut microbiome. ^{1 2 3 4 5}

Is donor human milk safe for infants?

Donor human milk is generally considered safe for infants, but it may contain harmful bacteria. Pasteurization and microbiological screening can reduce these risks, although the antimicrobial properties of the milk are diminished after pasteurization. ^{1 3 4 6 7}

How does donor human milk treatment differ from other treatments for infant gut microbiome development?

Donor human milk is unique because it contains a specific microbiome that can help seed the infant's gut with beneficial bacteria, which is not present in formula milk. Unlike formula, donor human milk can provide microbes that are similar to those found in a mother's own milk, potentially offering health benefits such as reduced risk of infections and better gut health. ^{1 3 5 8 9}

What is the purpose of this trial?

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 full-term infants who are born via caesarean section and require supplementation. Secondarily, this study aims to compare the infant health outcomes of sleep and growth between groups to assess if these outcomes are mediated by infant feeding type or potential differences in microbial signatures. Finally, this study will compare maternal outcomes of depression, anger, breastfeeding self-efficacy and breastfeeding rates between groups. The infant gut microbiome plays a critical role in the developing immune, neurologic, and endocrine systems. Yet, most infants experience early life disruptions (ELDs) to their microbiome that have potential long-term health and development impacts. A major source of disruption is caesarean section (c-section) delivery because the infant is born surgically and is not exposed to important commensal bacteria required to establish the infant microbiome. Currently in Canada, over 28% of infants are born via c-section. Exclusive breastfeeding can improve gut microbiota composition in infants who are born via c-section. However, approximately 60% of infants born via c-section require formula supplementation in their first week of life. Evidence indicates that even one bottle of formula can further disrupt the gut microbiome. Donor human milk (DHM) is a superior alternative to formula when supplementation is required as its biotic properties minimize perturbations to the infant gut microbiome and may help to repair the microbiome in infants who experience ELDs. Yet, while DHM is well researched in preterm populations, evidence on the impact of DHM as a therapeutic intervention on the full-term infant gut microbiome is lacking. The hypothesis of this study is: that replacing formula with DHM supplementation will minimize gut microbiome dysbiosis and foster homeostasis following supplementation. In addition, it is hypothesized that improved homeostasis will promote improved sleep and growth outcomes in participant infants. Finally, mothers whose infants receive DHM will have lower depression and anger scores and higher breastfeeding self-efficacy and exclusive breastfeeding rates compared to mothers whose infants receive formula.

Research Team

Meredith Brockway, PhD

Principal Investigator

University of Calgary

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

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

A Scoping Review of Research on the Human Milk Microbiome. [2022]

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

Improved feeding tolerance and growth are linked to increased gut microbial community diversity in very-low-birth-weight infants fed mother's own milk compared with donor breast milk. [2023]

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

Microbiological Screening of Donor Human Milk. [2023]

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

Diet-microbe-host interaction in early life. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Milk Microbiome and Neonatal Colonization: Overview. [2021]

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

Human Milk Microbial Community Structure Is Relatively Stable and Related to Variations in Macronutrient and Micronutrient Intakes in Healthy Lactating Women. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

The availability of probiotics and donor human milk is associated with improved survival in very preterm infants. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Milk Microbiota: What Are We Exactly Talking About? [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Human Milk Microbiota: Origin and Potential Uses. [2021]