Microbial ColonizationDO-RE-MI C-SNCT06177184
DOnor Milk to REpair the Full-term Infant MIcrobiome in Infants Born Via Cesarean Section.
A study testing Donor Human Milk - Nutritional Replacement in people with Microbial Colonization, run by University of Calgary at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 37 weeks and olderHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization
- What is being tested?
- Donor Human Milk - Nutritional Replacement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 37 weeks and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Gestation greater than 37 weeks gestation (full-term)
- Caesarean Section delivery
- Intending to breastfeed
- Consent for infant to receive DHM
- Working understanding (proficient in reading and understanding) of 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.
Who cannot join
- Diagnosed with clinically significant major congenital malformation that will interfere with breastfeeding or growth
- No intention to breastfeed
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Rockeyview General Hospital
Calgary, Alberta, T2V1P9
Dena Berci, MN, 403-943-3109, dena.berci@albertahealthservices.ca
Meredith Brockway, PhD, mbrockwa@ucalgary.ca
About this study
Official title: DOnor Milk to REpair the Full-term Infant MIcrobiome in Infants Born Via Caesarean Section
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.
Read more
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.
Read the detailed description
Investigators propose to conduct a pilot clinical RCT in the postpartum hospital setting examining DHM as an intervention provided to full-term infants delivered via caesarean section. Randomization of participant infants is currently an ethical practice because DHM supplementation is not standard practice in this population; infants receive formula if supplementation of mother's own milk (MOM) is required. Additionally, randomization will allow investigators to determine causal relationships between DHM supplementation compared to formula supplementation on the infant gut microbiome. Finally, conducting research in the clinical setting will allow for pragmatic assessment of DHM as an intervention, enhancing external validity and increasing the likelihood of its implementation into healthcare systems to improve healthcare quality.
Population: The population of interest is caesarean section born, full-term infants whose mothers are planning on breastfeeding.
Recruitment: Mothers greater than 37 weeks' gestation in the labour and delivery or postpartum unit who deliver via caesarean section will be screened for participation in the study by nurses on the postpartum and labour and delivery units. Upon recruitment and completion of informed consent, infants requiring supplementation of MOM will be randomized to the control or intervention group. Investigators will randomize 90 mother-infant dyads, providing adequate power to detect overall microbiome differences (~45 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 week, 3 months and 6 months postpartum.
Secondary outcomes include infant growth, sleep, and breastfeeding outcomes that will be collected at one week, 3 months and 6 months postpartum.
- Conditions
- Microbial Colonization
- Being tested
- Donor Human Milk - Nutritional Replacement
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donor Human Milk - Nutritional ReplacementOther
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 Association 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.
| Study group | Role | What they receive |
|---|---|---|
| Donor Human Milk | Experimental | Infants randomized to the intervention group will receive DHM each time supplementation is required for the first 7 days of life. Receives: Other: Donor Human Milk - Nutritional Replacement |
| Standard Care (Infant Formula) | No intervention | Infants randomized to the standard care group will receive formula each time supplementation is required for the first 7 days of life. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant gut microbiome - shallow shotgun metagenomics (RA)
Relative abundance
Measured: one week postpartum
Infant gut microbiome - shallow shotgun metagenomics (RA)
Relative abundance
Measured: three months postpartum
Infant gut microbiome - shallow shotgun metagenomics (RA)
Relative abundance
Measured: six months postpartum
Infant gut microbiome - shallow shotgun metagenomics (alpha diversity)
alpha diversity of microbiome
Measured: one week postpartum
Infant gut microbiome - shallow shotgun metagenomics (alpha diversity)
alpha diversity of microbiome
Measured: 3 months postpartum
Infant gut microbiome - shallow shotgun metagenomics (alpha diversity)
alpha diversity of microbiome
Measured: six months postpartum
Infant gut microbiome - shallow shotgun metagenomics (beta diversity)
beta diversity of microbiome
Measured: one week postpartum
Infant gut microbiome - shallow shotgun metagenomics (beta diversity)
beta diversity of microbiome
Measured: three months postpartum
Infant gut microbiome - shallow shotgun metagenomics (beta diversity)
beta diversity of microbiome
Measured: six months postpartum
Secondary outcomes (29)
Infant Sleep
Brief Infant Sleep Questionnaire - Revised Short Form - Scores on each subscale and the total score are scaled from 0 to 100, with higher scores denoting better sleep quality, more positive perception of infant sleep, and parent behaviors that promote healthy and independent sleep.
Measured: three months postpartum
Infant Sleep
Brief Infant Sleep Questionnaire - Scores on each subscale and the total score are scaled from 0 to 100, with higher scores denoting better sleep quality, more positive perception of infant sleep, and parent behaviors that promote healthy and independent sleep.
Measured: six months postpartum
Infant Growth - weight
Weight - in grams; weight and height will be combined to report BMI in kg/m^2
Measured: one week postpartum
Infant Growth - length
Length - in centimeters; weight and height will be combined to report BMI in kg/m^2
Measured: one week postpartum
Infant Growth - BMI
Body mass index - weight and height will be combined to report BMI in kg/m^2
Measured: one week postpartum
Infant Growth - BMI
Body mass index - weight and height will be combined to report BMI in kg/m^2
Measured: three months postpartum
Infant Growth - BMI
Body mass index - weight and height will be combined to report BMI in kg/m^2
Measured: six months postpartum
Infant Growth - head
Head circumference - in centimeters
Measured: one week postpartum
Infant Growth - weight
Weight - in grams; weight and height will be combined to report BMI in kg/m^2
Measured: three months postpartum
Infant Growth - length
Length - in centimeters; weight and height will be combined to report BMI in kg/m^2
Measured: three months postpartum
Infant Growth - head
Head circumference - in centimeters
Measured: three months postpartum
Infant Growth - weight
Weight - in grams; weight and height will be combined to report BMI in kg/m^2
Measured: six months postpartum
Infant Growth - length
Length - in centimeters; weight and height will be combined to report BMI in kg/m^2
Measured: six months postpartum
Infant Growth - head
Head circumference - in centimeters
Measured: six months postpartum
Infant feeding
breastfeeding exclusively - measured by 7-day infant feeding journal. Number of participants who consume only breastmilk.
Measured: one week postpartum
Infant feeding
breastfeeding exclusively - measured by 7-day maternal recall. Number of participants who consume only breastmilk.
Measured: three months postpartum
Infant feeding
breastfeeding exclusively - measured by 7-day maternal recall. Number of participants who consume only breastmilk.
Measured: six months postpartum
Maternal Depression
Edinburgh Postnatal Depression Screen - Range in score from 0 to 30; higher scores indicate worse outcomes
Measured: one week postpartum
Maternal Depression
Edinburgh Postnatal Depression Screen - Range in score from 0 to 30; higher scores indicate worse outcomes
Measured: three months postpartum
Maternal Depression
Edinburgh Postnatal Depression Screen - Range in score from 0 to 30; higher scores indicate worse outcomes
Measured: six months postpartum
Maternal Anger
LEVEL 2 - ANGER - Adult (PROMIS Emotional Distress - Anger - Short Form): Range in score from 5 to 25 with higher scores indicating greater severity of anger.
Measured: one week postpartum
Maternal Anger
LEVEL 2 - ANGER - Adult (PROMIS Emotional Distress - Anger - Short Form): Range in score from 5 to 25 with higher scores indicating greater severity of anger.
Measured: three months postpartum
Maternal Anger
LEVEL 2 - ANGER - Adult (PROMIS Emotional Distress - Anger - Short Form): Range in score from 5 to 25 with higher scores indicating greater severity of anger.
Measured: six months postpartum
Maternal Breastfeeding Self-efficacy
Breastfeeding self-efficacy scale - short form: Total scores range from 14 to 70, with higher scores reflecting more significant levels of breastfeeding self-efficacy.
Measured: one week postpartum
Maternal Breastfeeding Self-efficacy
Breastfeeding self-efficacy scale - short form: Total scores range from 14 to 70, with higher scores reflecting more significant levels of breastfeeding self-efficacy.
Measured: three months postpartum
Maternal Breastfeeding Self-efficacy
Breastfeeding self-efficacy scale - short form: Total scores range from 14 to 70, with higher scores reflecting more significant levels of breastfeeding self-efficacy.
Measured: six months postpartum
Maternal Anxiety
State-trait Anxiety inventory: Total scores range from 20 to 80 (each for state and trait), with higher scores indicating worse outcomes (higher anxiety).
Measured: Baseline - (birth/enrolment)
Maternal Anxiety
State-trait Anxiety inventory: Total scores range from 20 to 80 (each for state and trait), with higher scores indicating worse outcomes (higher anxiety).
Measured: three months postpartum
Maternal Anxiety
State-trait Anxiety inventory: Total scores range from 20 to 80 (each for state and trait), with higher scores indicating worse outcomes (higher anxiety).
Measured: six months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start1 Oct 2024
- Primary completion1 May 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An experimental study design in which each participant will be randomized to one of two groups (intervention \[DHM\] or standard care/control \[formula\]).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia, University of Victoria, NorthernStar Mothers Milk Bank
- Responsible party
- Principal investigator, Meredith Brockway, University of Calgary
- Investigators
- Meredith Brockway, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177184
- Sponsor's protocol ID
- REB23-1356
- Acronym
- DO-RE-MI C-S
- Status last verified
- Mar 2025
- First submitted
- 11 Dec 2023
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to share IPD with other researchers
Publications
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.
PubMed 30529020Matenchuk 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.
PubMed 32668369Tamburini 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.
PubMed 27387886Arrieta 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.
PubMed 25250028Korpela K, de Vos WM. Infant gut microbiota restoration: state of the art. Gut Microbes. 2022 Jan-Dec;14(1):2118811. doi: 10.1080/19490976.2022.2118811.
PubMed 36093611Persaud 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.
PubMed 25053193Zimmermann 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.
PubMed 31296695Stuivenberg GA, Burton JP, Bron PA, Reid G. Why Are Bifidobacteria Important for Infants? Microorganisms. 2022 Jan 25;10(2):278. doi: 10.3390/microorganisms10020278.
PubMed 35208736Liu 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.
PubMed 30972048Korpela K, Salonen A, Virta LJ, Kekkonen RA, de Vos WM. Association of Early-Life Antibiotic Use and Protective Effects of Breastfeeding: Role of the Intestinal Microbiota. JAMA Pediatr. 2016 Aug 1;170(8):750-7. doi: 10.1001/jamapediatrics.2016.0585.
PubMed 27294842Dai 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.
PubMed 36603585Forbes JD, Azad MB, Vehling L, Tun HM, Konya TB, Guttman DS, Field CJ, Lefebvre D, Sears MR, Becker AB, Mandhane PJ, Turvey SE, Moraes TJ, Subbarao P, Scott JA, Kozyrskyj AL; Canadian Healthy Infant Longitudinal Development (CHILD) Study Investigators. Association of Exposure to Formula in the Hospital and Subsequent Infant Feeding Practices With Gut Microbiota and Risk of Overweight in the First Year of Life. JAMA Pediatr. 2018 Jul 2;172(7):e181161. doi: 10.1001/jamapediatrics.2018.1161. Epub 2018 Jul 2.
PubMed 29868719Francis 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.
PubMed 33658034Ho NT, Li F, Lee-Sarwar KA, Tun HM, Brown BP, Pannaraj PS, Bender JM, Azad MB, Thompson AL, Weiss ST, Azcarate-Peril MA, Litonjua AA, Kozyrskyj AL, Jaspan HB, Aldrovandi GM, Kuhn L. Meta-analysis of effects of exclusive breastfeeding on infant gut microbiota across populations. Nat Commun. 2018 Oct 9;9(1):4169. doi: 10.1038/s41467-018-06473-x.
PubMed 30301893Chong 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.
PubMed 36079814
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DOnor Milk to REpair the Full-term Infant MIcrobiome in Infants Born Via Caesarean Section
- ClinicalTrials.gov ID
- NCT06177184
- Acronym / sponsor ID
- DO-RE-MI C-S / REB23-1356
- Conditions
- Microbial Colonization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- University of British Columbia, University of Victoria, NorthernStar Mothers Milk Bank
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Investigators propose to conduct a pilot clinical RCT in the postpartum hospital setting examining DHM as an intervention provided to full-term infants delivered via caesarean section. Randomization of participant infants is currently an ethical practice because DHM supplementation is not standard practice in this population; infants receive formula if supplementation of mother's own milk (MOM) is required. Additionally, randomization will allow investigators to determine causal relationships between DHM supplementation compared to formula supplementation on the infant gut microbiome. Finally, conducting research in the clinical setting will allow for pragmatic assessment of DHM as an intervention, enhancing external validity and increasing the likelihood of its implementation into healthcare systems to improve healthcare quality.
Population: The population of interest is caesarean section born, full-term infants whose mothers are planning on breastfeeding.
Recruitment: Mothers greater than 37 weeks' gestation in the labour and delivery or postpartum unit who deliver via caesarean section will be screened for participation in the study by nurses on the postpartum and labour and delivery units. Upon recruitment and completion of informed consent, infants requiring supplementation of MOM will be randomized to the control or intervention group. Investigators will randomize 90 mother-infant dyads, providing adequate power to detect overall microbiome differences (~45 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 week, 3 months and 6 months postpartum.
Secondary outcomes include infant growth, sleep, and breastfeeding outcomes that will be collected at one week, 3 months and 6 months postpartum.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- An experimental study design in which each participant will be randomized to one of two groups (intervention [DHM] or standard care/control [formula]).
| Arm | Type | Receives |
|---|---|---|
| Donor Human Milk | Experimental | Other: Donor Human Milk - Nutritional ReplacementInfants randomized to the intervention group will receive DHM each time supplementation is required for the first 7 days of life. |
| Standard Care (Infant Formula) | No intervention | –Infants randomized to the standard care group will receive formula each time supplementation is required for the first 7 days of life. |
Who may qualify
- Ages
- 37 weeks and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Gestation greater than 37 weeks gestation (full-term)
- Caesarean Section delivery
- Intending to breastfeed
- Consent for infant to receive DHM
- Working understanding (proficient in reading and understanding) of English
Key exclusion criteria (2 listed)
- Diagnosed with clinically significant major congenital malformation that will interfere with breastfeeding or growth
- No intention to breastfeed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Donor Human Milk - Nutritional ReplacementAll 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 Association 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. | Other | Donor Human Milk |
Primary outcome
Infant gut microbiome - shallow shotgun metagenomics (RA)
Time frame: one week postpartum
Relative abundance
Infant gut microbiome - shallow shotgun metagenomics (RA)
Time frame: three months postpartum
Relative abundance
Infant gut microbiome - shallow shotgun metagenomics (RA)
Time frame: six months postpartum
Relative abundance
Infant gut microbiome - shallow shotgun metagenomics (alpha diversity)
Time frame: one week postpartum
alpha diversity of microbiome
Infant gut microbiome - shallow shotgun metagenomics (alpha diversity)
Time frame: 3 months postpartum
alpha diversity of microbiome
Infant gut microbiome - shallow shotgun metagenomics (alpha diversity)
Time frame: six months postpartum
alpha diversity of microbiome
Infant gut microbiome - shallow shotgun metagenomics (beta diversity)
Time frame: one week postpartum
beta diversity of microbiome
Infant gut microbiome - shallow shotgun metagenomics (beta diversity)
Time frame: three months postpartum
beta diversity of microbiome
Infant gut microbiome - shallow shotgun metagenomics (beta diversity)
Time frame: six months postpartum
beta diversity of microbiome
29 secondary outcomes
Infant Sleep
Time frame: three months postpartum
Infant Sleep
Time frame: six months postpartum
Infant Growth - weight
Time frame: one week postpartum
Infant Growth - length
Time frame: one week postpartum
Infant Growth - BMI
Time frame: one week postpartum
Infant Growth - BMI
Time frame: three months postpartum
Infant Growth - BMI
Time frame: six months postpartum
Infant Growth - head
Time frame: one week postpartum
Infant Growth - weight
Time frame: three months postpartum
Infant Growth - length
Time frame: three months postpartum
Infant Growth - head
Time frame: three months postpartum
Infant Growth - weight
Time frame: six months postpartum
Infant Growth - length
Time frame: six months postpartum
Infant Growth - head
Time frame: six months postpartum
Infant feeding
Time frame: one week postpartum
Infant feeding
Time frame: three months postpartum
Infant feeding
Time frame: six months postpartum
Maternal Depression
Time frame: one week postpartum
Maternal Depression
Time frame: three months postpartum
Maternal Depression
Time frame: six months postpartum
Maternal Anger
Time frame: one week postpartum
Maternal Anger
Time frame: three months postpartum
Maternal Anger
Time frame: six months postpartum
Maternal Breastfeeding Self-efficacy
Time frame: one week postpartum
Maternal Breastfeeding Self-efficacy
Time frame: three months postpartum
Maternal Breastfeeding Self-efficacy
Time frame: six months postpartum
Maternal Anxiety
Time frame: Baseline - (birth/enrolment)
Maternal Anxiety
Time frame: three months postpartum
Maternal Anxiety
Time frame: six months postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Results publication: PubMed 30529020Robertson 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.
- Results publication: PubMed 32668369Matenchuk 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.
- Results publication: PubMed 27387886Tamburini 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.
- Results publication: PubMed 25250028Arrieta 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.
- Results publication: PubMed 36093611Korpela K, de Vos WM. Infant gut microbiota restoration: state of the art. Gut Microbes. 2022 Jan-Dec;14(1):2118811. doi: 10.1080/19490976.2022.2118811.
- Results publication: PubMed 25053193Persaud 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.
- Results publication: PubMed 31296695Zimmermann 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.
- Results publication: PubMed 35208736Stuivenberg GA, Burton JP, Bron PA, Reid G. Why Are Bifidobacteria Important for Infants? Microorganisms. 2022 Jan 25;10(2):278. doi: 10.3390/microorganisms10020278.
- Results publication: PubMed 30972048Liu 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.
- Results publication: PubMed 27294842Korpela K, Salonen A, Virta LJ, Kekkonen RA, de Vos WM. Association of Early-Life Antibiotic Use and Protective Effects of Breastfeeding: Role of the Intestinal Microbiota. JAMA Pediatr. 2016 Aug 1;170(8):750-7. doi: 10.1001/jamapediatrics.2016.0585.
- Results publication: PubMed 36603585Dai 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.
- Results publication: PubMed 29868719Forbes JD, Azad MB, Vehling L, Tun HM, Konya TB, Guttman DS, Field CJ, Lefebvre D, Sears MR, Becker AB, Mandhane PJ, Turvey SE, Moraes TJ, Subbarao P, Scott JA, Kozyrskyj AL; Canadian Healthy Infant Longitudinal Development (CHILD) Study Investigators. Association of Exposure to Formula in the Hospital and Subsequent Infant Feeding Practices With Gut Microbiota and Risk of Overweight in the First Year of Life. JAMA Pediatr. 2018 Jul 2;172(7):e181161. doi: 10.1001/jamapediatrics.2018.1161. Epub 2018 Jul 2.
- Individual participant dataSharing planned: No. no plan to share IPD with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Meredith Brockway, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Donor Human Milk - Nutritional Replacement in people with Microbial Colonization, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meredith Brockway, PhD (403-689-0970, mbrockwa@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant gut microbiome - shallow shotgun metagenomics (RA) (time frame: one week postpartum). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06177184, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.