The Human Microbiome and Child Growth - First 1000 Days and Beyond.
Ruairi C Robertson, Amee R Manges, B Brett Finlay...
https://pubmed.ncbi.nlm.nih.gov/30529020Actively Recruiting
Phase Not Applicable
Age: 37Weeks +
All Genders
Healthy Volunteers
ID06177184
Donor Milk to Repair the Full-term Infant Microbiome in Infants Born Via Caesarean Section
Led by University of Calgary · Updated on 2026-02-20
90
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
Sponsors
U
University of Calgary
Lead Sponsor
U
University of British Columbia
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the effect of donor human milk (DHM) compared to formula supplementation on the gut microbiome of full-term infants born by caesarean section who require supplementation. The study aims to understand how DHM influences infant gut bacteria, sleep, growth, and maternal outcomes including depression, anger, breastfeeding confidence, and breastfeeding rates. This pilot randomized controlled trial evaluates DHM as a potential alternative to formula in supporting infant health and maternal well-being. Infants in this study will be randomly assigned to receive either donor human milk or formula each time supplementation is needed during the first seven days of life. DHM used is pasteurized and provided through certified milk banks. The intervention period focuses on the early postpartum week when breastfeeding is being established and formula supplementation is most common. The control group will receive standard care with formula supplementation. Participants will be followed with stool sample collections at one week, three months, and six months to assess differences in gut microbiome diversity and composition. Infant growth measurements, sleep patterns, and breastfeeding outcomes will also be monitored at these timepoints. Maternal mental health, including depression and anger, as well as breastfeeding self-efficacy, will be evaluated from birth through six months postpartum. The study is designed to collect comprehensive data on infant and maternal health outcomes related to feeding type over half a year.
CONDITIONS
Brief Title
DOnor Milk to REpair the Full-term Infant MIcrobiome in Infants Born Via Cesarean Section.
Who Can Participate
Age: 37Weeks +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Gestation greater than 37 weeks (full-term)
- Delivered by caesarean section
- Intending to breastfeed
- Consent for infant to receive donor human milk
- Able to read and understand English
- Mother has provided signed informed consent and authorization for health information use
- Mother is able to comply with study requirements and likely to complete the study
You will not qualify if you...
- Diagnosed with major congenital malformation affecting breastfeeding or growth
- No intention to breastfeed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 7 days
Participants receive donor human milk or formula supplementation each time supplementation is required for the first 7 days of life.
Supplementation as needed during the first week of life
Follow-up
Duration - 6 months
Participants are monitored with stool sample collections and assessments of infant growth, sleep, breastfeeding outcomes, and maternal mental health.
3 visits at 1 week, 3 months, and 6 months postpartum
Trial Site Locations
Total: 1 location
1
Rockeyview General Hospital
Calgary, Alberta, Canada, T2V1P9
Actively Recruiting
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Research Team
M
Meredith Brockway, PhD
J
Jannette Festival, BN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Sleep, circadian rhythm, and gut microbiota.
Brittany A Matenchuk, Piush J Mandhane, Anita L Kozyrskyj
https://pubmed.ncbi.nlm.nih.gov/32668369The microbiome in early life: implications for health outcomes.
Sabrina Tamburini, Nan Shen, Han Chih Wu...
https://pubmed.ncbi.nlm.nih.gov/27387886The intestinal microbiome in early life: health and disease.
Marie-Claire Arrieta, Leah T Stiemsma, Nelly Amenyogbe...
https://pubmed.ncbi.nlm.nih.gov/25250028Infant gut microbiota restoration: state of the art.
Katri Korpela, Willem M de Vos
https://pubmed.ncbi.nlm.nih.gov/36093611Perinatal antibiotic exposure of neonates in Canada and associated risk factors: a population-based study.
Ryan R Persaud, Meghan B Azad, Radha S Chari...
https://pubmed.ncbi.nlm.nih.gov/25053193Effect of intrapartum antibiotics on the intestinal microbiota of infants: a systematic review.
Petra Zimmermann, Nigel Curtis
https://pubmed.ncbi.nlm.nih.gov/31296695Why Are Bifidobacteria Important for Infants?
Gerrit A Stuivenberg, Jeremy P Burton, Peter A Bron...
https://pubmed.ncbi.nlm.nih.gov/35208736The Perturbation of Infant Gut Microbiota Caused by Cesarean Delivery Is Partially Restored by Exclusive Breastfeeding.
Yu Liu, Shengtang Qin, Yilin Song...
https://pubmed.ncbi.nlm.nih.gov/30972048Association of Early-Life Antibiotic Use and Protective Effects of Breastfeeding: Role of the Intestinal Microbiota.
Katri Korpela, Anne Salonen, Lauri J Virta...
https://pubmed.ncbi.nlm.nih.gov/27294842