Comparing Impacts of Donor Human Milk to Formula Supplementation on the Gut Microbiome of Full-term Infants
NCT ID: NCT05815433
Last Updated: 2025-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
105 participants
INTERVENTIONAL
2023-09-01
2025-12-31
Brief Summary
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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 high breastfeeding self-efficacy and exclusive breastfeeding rates compared to mothers whose infants receive formula.
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Detailed Description
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Population: The population of interest is vaginally born, full-term infants who are exposed to antibiotics in labour through IAP and whose mothers are planning on breastfeeding.
Recruitment: Mothers greater than 37 weeks' gestation admitted to the postpartum unit who test positive for GBS and deliver vaginally will be screened for participation in the study by nurses on the postpartum unit. Approximately 20% of all pregnant mothers will test positive for GBS and Alberta Health Services protocol indicates that GBS-positive mothers are given intravenous antibiotics during labour. Only mothers who receive the complete Alberta Health Services protocol will qualify for the study. Upon recruitment and completion of informed consent, infants requiring supplementation of MOM will be randomized to the control or intervention group. Investigators will randomize 60 mother-infant dyads, providing adequate power to detect overall microbiome differences (\~30 in each group).
Intervention - Donor Human Milk (DHM): Infants randomized to the intervention group will receive DHM each time supplementation is required for the first 7 days of life. The exposure time of 7 days was selected due to feasibility of DHM cost, and this is the period when breastfeeding is being established and most formula supplementation occurs. Infants in the control group will receive formula when supplementation is required (standard care). All DHM in North America is pasteurized and provided through certified milk banks regulated by the Human Milk Banking Association of North America and DHM for this study will be obtained from the NorthernStar Mothers Milk Bank (NMMB).
Data Collection, Analysis, and Outcomes: The primary outcome for this pilot study will result from comparisons of DHM to formula supplementation groups for differences in microbiome signatures, such as diversity, proportions of Bifidobacteria, and proportions of pathogenic organisms. Infant stool samples will be collected from soiled diapers at one, six and 12 weeks postpartum.
Secondary outcomes include infant growth, sleep, and breastfeeding outcomes that will be collected at one, six and 12 weeks postpartum.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Donor Human Milk
Infants randomized to the intervention group will receive DHM each time supplementation is required for the first 7 days of life.
Donor Human Milk - Nutritional Replacement
All DHM in North America is pasteurized and provided through certified milk banks regulated by the Human Milk Banking Association of North America. DHM for this study will be obtained from the NorthernStar Mothers Milk Bank (NMMB). The milk is pasteurized and rigorously tested according to Human Milk Banking of North America guidelines. In Canada, DHM is categorized as food or nutritional therapy and the milk bank is monitored and certified by the Canadian Food Inspection Agency. The product used for this study will be the same product that is provided to other hospital units (mainly the neonatal intensive care units) in Alberta and around Canada. The product will not be modified or tampered with in any way.
Standard Care (Infant Formula)
Infants randomized to the standard care group will receive formula each time supplementation is required for the first 7 days of life.
No interventions assigned to this group
Interventions
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Donor Human Milk - Nutritional Replacement
All DHM in North America is pasteurized and provided through certified milk banks regulated by the Human Milk Banking Association of North America. DHM for this study will be obtained from the NorthernStar Mothers Milk Bank (NMMB). The milk is pasteurized and rigorously tested according to Human Milk Banking of North America guidelines. In Canada, DHM is categorized as food or nutritional therapy and the milk bank is monitored and certified by the Canadian Food Inspection Agency. The product used for this study will be the same product that is provided to other hospital units (mainly the neonatal intensive care units) in Alberta and around Canada. The product will not be modified or tampered with in any way.
Eligibility Criteria
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Inclusion Criteria
* Completion of antibiotic protocol for GBS during labour
* Vaginal delivery
* Intending on breastfeeding
* Consent for infant to receive DHM
* Working understanding (proficient in reading and understanding) English
* Mother has provided signed and dated informed consent and authorization to use protected health information, as required by national and local regulations.
* 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.
Exclusion Criteria
* No intention to breastfeed
* Receiving extended courses of antibiotics (beyond that of the IAP in labour)
37 Weeks
ALL
Yes
Sponsors
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University of British Columbia
OTHER
University of Victoria
OTHER
NorthernStar Mothers Milk Bank
UNKNOWN
University of Calgary
OTHER
Responsible Party
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Meredith Brockway
Assistant Professor
Principal Investigators
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Meredith Brockway, PhD RN
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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Rockyview General Hospital
Calgary, Alberta, Canada
Countries
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References
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Matenchuk BA, Mandhane PJ, Kozyrskyj AL. Sleep, circadian rhythm, and gut microbiota. Sleep Med Rev. 2020 Oct;53:101340. doi: 10.1016/j.smrv.2020.101340. Epub 2020 May 13.
Robertson RC, Manges AR, Finlay BB, Prendergast AJ. The Human Microbiome and Child Growth - First 1000 Days and Beyond. Trends Microbiol. 2019 Feb;27(2):131-147. doi: 10.1016/j.tim.2018.09.008. Epub 2018 Oct 24.
Tamburini S, Shen N, Wu HC, Clemente JC. The microbiome in early life: implications for health outcomes. Nat Med. 2016 Jul 7;22(7):713-22. doi: 10.1038/nm.4142.
Arrieta MC, Stiemsma LT, Amenyogbe N, Brown EM, Finlay B. The intestinal microbiome in early life: health and disease. Front Immunol. 2014 Sep 5;5:427. doi: 10.3389/fimmu.2014.00427. eCollection 2014.
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Persaud RR, Azad MB, Chari RS, Sears MR, Becker AB, Kozyrskyj AL; CHILD Study Investigators. Perinatal antibiotic exposure of neonates in Canada and associated risk factors: a population-based study. J Matern Fetal Neonatal Med. 2015 Jul;28(10):1190-5. doi: 10.3109/14767058.2014.947578. Epub 2014 Aug 14.
Zimmermann P, Curtis N. Effect of intrapartum antibiotics on the intestinal microbiota of infants: a systematic review. Arch Dis Child Fetal Neonatal Ed. 2020 Mar;105(2):201-208. doi: 10.1136/archdischild-2018-316659. Epub 2019 Jul 11.
Stuivenberg GA, Burton JP, Bron PA, Reid G. Why Are Bifidobacteria Important for Infants? Microorganisms. 2022 Jan 25;10(2):278. doi: 10.3390/microorganisms10020278.
Liu Y, Qin S, Song Y, Feng Y, Lv N, Xue Y, Liu F, Wang S, Zhu B, Ma J, Yang H. The Perturbation of Infant Gut Microbiota Caused by Cesarean Delivery Is Partially Restored by Exclusive Breastfeeding. Front Microbiol. 2019 Mar 26;10:598. doi: 10.3389/fmicb.2019.00598. eCollection 2019.
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Dai DLY, Petersen C, Hoskinson C, Del Bel KL, Becker AB, Moraes TJ, Mandhane PJ, Finlay BB, Simons E, Kozyrskyj AL, Patrick DM, Subbarao P, Bode L, Azad MB, Turvey SE. Breastfeeding enrichment of B. longum subsp. infantis mitigates the effect of antibiotics on the microbiota and childhood asthma risk. Med. 2023 Feb 10;4(2):92-112.e5. doi: 10.1016/j.medj.2022.12.002. Epub 2023 Jan 4.
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Francis J, Mildon A, Stewart S, Underhill B, Ismail S, Di Ruggiero E, Tarasuk V, Sellen DW, O'Connor DL. Breastfeeding rates are high in a prenatal community support program targeting vulnerable women and offering enhanced postnatal lactation support: a prospective cohort study. Int J Equity Health. 2021 Mar 3;20(1):71. doi: 10.1186/s12939-021-01386-6.
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Chong HY, Tan LT, Law JW, Hong KW, Ratnasingam V, Ab Mutalib NS, Lee LH, Letchumanan V. Exploring the Potential of Human Milk and Formula Milk on Infants' Gut and Health. Nutrients. 2022 Aug 29;14(17):3554. doi: 10.3390/nu14173554.
Peila C, Moro GE, Bertino E, Cavallarin L, Giribaldi M, Giuliani F, Cresi F, Coscia A. The Effect of Holder Pasteurization on Nutrients and Biologically-Active Components in Donor Human Milk: A Review. Nutrients. 2016 Aug 2;8(8):477. doi: 10.3390/nu8080477.
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Whipps MDM, Yoshikawa H, Demirci JR, Hill J. Estimating the Impact of In-Hospital Infant Formula Supplementation on Breastfeeding Success. Breastfeed Med. 2021 Jul;16(7):530-538. doi: 10.1089/bfm.2020.0194. Epub 2021 Jun 10.
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Other Identifiers
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RMS23-99633743
Identifier Type: -
Identifier Source: org_study_id
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