Microbial ColonizationMMOMSSNCT04130165
Matching Donor Human Milk On Maternal Secretor Status (MMOMSS) Study
A study testing Matched donor human milk in people with Microbial Colonization and Preterm Birth, run by University of Manitoba at 1 site in Canada.
Trial summary
This study will evaluate the impact of matching donor human milk to the maternal secretor status of very preterm infants (<34 weeks gestation) on the gut microbiome. Half of enrolled infants will receive donor human milk which is matched their mother's secretor status and half will receive standard (unmatched) donor… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Microbial Colonization, Preterm Birth
- What is being tested?
- Matched donor human milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteCanada
- Study dates
- 29 May 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gestation up to 33 6/7 weeks at hospital admission (to guarantee at least 14 days intervention, since DHM fortification typically ends at 34+0 weeks adjusted gestational age).
- Provision of consent for infant to receive DHM.
- 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 is able to 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
- Intestinal perforation or stage 2 necrotizing enterocolitis (NEC)
- Unlikely to survive the study period
- Receiving extended courses of antibiotics (most infants are expected to receive up to 48hr antibiotic prophylaxis at birth according to standard NICU protocol; this criterion will only exclude infants receiving prolonged courses of antibiotics)
- Presence prior to enrollment of intestinal perforation or stage 2 necrotizing enterocolitis (NEC) prior to tolerating fortified feeds
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing the Prebiotic Profile of Donor Human Milk for Preterm Infants: Feasibility of a New Donor Milk Matching Strategy Based on Maternal Secretor Status
This study will evaluate the impact of matching donor human milk to the maternal secretor status of very preterm infants (<34 weeks gestation) on the gut microbiome. Half of enrolled infants will receive donor human milk which is matched their mother's secretor status and half will receive standard (unmatched) donor human milk, which is standard care in the neonatal intensive care unit.
Read the detailed description
Background: The gut microbiome is established early in life and plays an important role in developing the immune system and metabolism. Infants born prematurely (before 37-weeks gestation) account for 1 in 10 births worldwide and are especially vulnerable to serious microbiome-mediated illnesses such as necrotizing enterocolitis and metabolic diseases. Breastfeeding is the most important factor shaping the infant gut microbiome, providing human milk oligosaccharides (HMOs) that serve as prebiotics for beneficial gut bacteria. Donor human milk (DHM) is considered the best alternative when mothers own milk (MOM) is not available. HMO profiles are highly variable between mothers and there is currently no "matching" process to optimize pairing of DHM and recipient infants. The strongest factor influencing HMO composition is maternal secretor status, determined by the expression of a specific gene (α-1, 2-fucosyltransferase-2). About 20% of Caucasians are non-secretors and researchers do not know the impact of feeding DHM from secretor donors to infants of non-secretor mothers. In this study, investigators aim to explore if matching DHM based on maternal secretor status impacts the development of the gut microbiome in preterm infants.
Method: Investigators will use a pilot, randomized, controlled trial to compare three groups of preterm infants (<34 weeks gestation): 1) infants receiving DHM matched to their mother's secretor status, 2) infants receiving standard issue (i.e. unmatched) DHM, and 3) infants who do not require DHM because they are exclusively receiving MOM. Mothers <34 weeks gestation admitted to antenatal units and the labour and delivery units will be screened for eligibility. Enrolled mothers will be randomized to either the intervention (n=30; matched DHM) or control group (n=30; standard unmatched DHM). Infants of mothers assigned to the intervention group will receive "matched" DHM based on maternal secretor status, determined after randomization. Infant fecal samples will be collected weekly from soiled diapers until discontinuation of DHM or discharge/transfer from the unit. Samples of MOM and DHM will also be collected to analyze milk for HMO and nutrient content. Microbial DNA will be analyzed using 16S sequencing. Additionally, for a subset of samples selected based on 16S results, investigators will perform shotgun metagenomics to identify microbial population structures and functional capacity. Microbial composition from intervention (matched DHM), control (unmatched DHM) and reference (exclusive MOM) groups will be compared to determine differences in microbial diversity and taxonomy.
Impact on healthcare: If promising, investigators would like to examine this phenomenon in a much larger cohort of preterm infants from NICUs across Canada. This research could revolutionize how milk banks and neonatal intensive care units provide DHM to preterm infants. Finally, this research will expand on understanding of the prebiotic effects of HMOs on infant microbiome and may inform future prebiotic/probiotic supplementation regimens.
- Conditions
- Microbial Colonization, Preterm Birth
- Being tested
- Matched donor human milk
- Keywords
- preterm infants, human milk, microbiome, donor human milk, breastmilk
- Medical subject headings
- Communicable Diseases, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Matched donor human milkOther
Milk from donor mothers will be sorted according to their secretor status. This milk will be provided to infants in the intervention (experimental) arm.
| Study group | Role | What they receive |
|---|---|---|
| Matched donor human milk | Experimental | Infants randomized to the matched donor human milk arm, will receive donor human milk which is matched to their mother's secretor status. Receives: Other: Matched donor human milk |
| Standard issue donor human milk | No intervention | Infants randomized to the standard issue donor human milk arm, will receive donor human milk which is prepared without consideration of secretor status as per standard practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal microbiome composition
16S RNA sequencing of fecal bacteria
Measured: sampled weekly until infant transferred from level III NICU, they are no longer receiving donor human milk or up to 60 days, whichever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start29 May 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Why it stopped: A variety of feasibility issues. Could not recruit in a timely manner.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 ManitobaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot Randomized Control Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary
- Responsible party
- Principal investigator, Meghan Azad, University of Manitoba
- Investigators
- Meghan B Azad, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130165
- Sponsor's protocol ID
- REB19-0542
- Acronym
- MMOMSS
- Status last verified
- Dec 2024
- First submitted
- 14 Oct 2019
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time we plan to share IPD within our research team only. We will consider sharing with other researchers in the future
Publications
Azad MB, Robertson B, Atakora F, Becker AB, Subbarao P, Moraes TJ, Mandhane PJ, Turvey SE, Lefebvre DL, Sears MR, Bode L. Human Milk Oligosaccharide Concentrations Are Associated with Multiple Fixed and Modifiable Maternal Characteristics, Environmental Factors, and Feeding Practices. J Nutr. 2018 Nov 1;148(11):1733-1742. doi: 10.1093/jn/nxy175.
PubMed 30247646Bode L. Human milk oligosaccharides: every baby needs a sugar mama. Glycobiology. 2012 Sep;22(9):1147-62. doi: 10.1093/glycob/cws074. Epub 2012 Apr 18.
PubMed 22513036Marx C, Bridge R, Wolf AK, Rich W, Kim JH, Bode L. Human milk oligosaccharide composition differs between donor milk and mother's own milk in the NICU. J Hum Lact. 2014 Feb;30(1):54-61. doi: 10.1177/0890334413513923. Epub 2013 Nov 26.
PubMed 24282194Parra-Llorca A, Gormaz M, Alcantara C, Cernada M, Nunez-Ramiro A, Vento M, Collado MC. Preterm Gut Microbiome Depending on Feeding Type: Significance of Donor Human Milk. Front Microbiol. 2018 Jun 27;9:1376. doi: 10.3389/fmicb.2018.01376. eCollection 2018.
PubMed 29997594Lewis ZT, Totten SM, Smilowitz JT, Popovic M, Parker E, Lemay DG, Van Tassell ML, Miller MJ, Jin YS, German JB, Lebrilla CB, Mills DA. Maternal fucosyltransferase 2 status affects the gut bifidobacterial communities of breastfed infants. Microbiome. 2015 Apr 10;3:13. doi: 10.1186/s40168-015-0071-z. eCollection 2015.
PubMed 25922665
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Prebiotic Profile of Donor Human Milk for Preterm Infants: Feasibility of a New Donor Milk Matching Strategy Based on Maternal Secretor Status
- ClinicalTrials.gov ID
- NCT04130165
- Acronym / sponsor ID
- MMOMSS / REB19-0542
- Conditions
- Microbial Colonization, Preterm Birth
- Keywords
- preterm infants, human milk, microbiome, donor human milk, breastmilk
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A variety of feasibility issues. Could not recruit in a timely manner.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- University of Calgary
- Study start
- 29 May 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 17 Oct 2019 (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.
This study will evaluate the impact of matching donor human milk to the maternal secretor status of very preterm infants (<34 weeks gestation) on the gut microbiome. Half of enrolled infants will receive donor human milk which is matched their mother's secretor status and half will receive standard (unmatched) donor human milk, which is standard care in the neonatal intensive care unit.
Detailed description
Background: The gut microbiome is established early in life and plays an important role in developing the immune system and metabolism. Infants born prematurely (before 37-weeks gestation) account for 1 in 10 births worldwide and are especially vulnerable to serious microbiome-mediated illnesses such as necrotizing enterocolitis and metabolic diseases. Breastfeeding is the most important factor shaping the infant gut microbiome, providing human milk oligosaccharides (HMOs) that serve as prebiotics for beneficial gut bacteria. Donor human milk (DHM) is considered the best alternative when mothers own milk (MOM) is not available. HMO profiles are highly variable between mothers and there is currently no "matching" process to optimize pairing of DHM and recipient infants. The strongest factor influencing HMO composition is maternal secretor status, determined by the expression of a specific gene (α-1, 2-fucosyltransferase-2). About 20% of Caucasians are non-secretors and researchers do not know the impact of feeding DHM from secretor donors to infants of non-secretor mothers. In this study, investigators aim to explore if matching DHM based on maternal secretor status impacts the development of the gut microbiome in preterm infants.
Method: Investigators will use a pilot, randomized, controlled trial to compare three groups of preterm infants (<34 weeks gestation): 1) infants receiving DHM matched to their mother's secretor status, 2) infants receiving standard issue (i.e. unmatched) DHM, and 3) infants who do not require DHM because they are exclusively receiving MOM. Mothers <34 weeks gestation admitted to antenatal units and the labour and delivery units will be screened for eligibility. Enrolled mothers will be randomized to either the intervention (n=30; matched DHM) or control group (n=30; standard unmatched DHM). Infants of mothers assigned to the intervention group will receive "matched" DHM based on maternal secretor status, determined after randomization. Infant fecal samples will be collected weekly from soiled diapers until discontinuation of DHM or discharge/transfer from the unit. Samples of MOM and DHM will also be collected to analyze milk for HMO and nutrient content. Microbial DNA will be analyzed using 16S sequencing. Additionally, for a subset of samples selected based on 16S results, investigators will perform shotgun metagenomics to identify microbial population structures and functional capacity. Microbial composition from intervention (matched DHM), control (unmatched DHM) and reference (exclusive MOM) groups will be compared to determine differences in microbial diversity and taxonomy.
Impact on healthcare: If promising, investigators would like to examine this phenomenon in a much larger cohort of preterm infants from NICUs across Canada. This research could revolutionize how milk banks and neonatal intensive care units provide DHM to preterm infants. Finally, this research will expand on understanding of the prebiotic effects of HMOs on infant microbiome and may inform future prebiotic/probiotic supplementation regimens.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Matched donor human milk | Experimental | Other: Matched donor human milkInfants randomized to the matched donor human milk arm, will receive donor human milk which is matched to their mother's secretor status. |
| Standard issue donor human milk | No intervention | –Infants randomized to the standard issue donor human milk arm, will receive donor human milk which is prepared without consideration of secretor status as per standard practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Gestation up to 33 6/7 weeks at hospital admission (to guarantee at least 14 days intervention, since DHM fortification typically ends at 34+0 weeks adjusted gestational age).
- Provision of consent for infant to receive DHM.
- 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 is able to comply with protocol requirements, instructions, and protocol-stated restrictions, and is likely to complete the study as planned.
Key exclusion criteria (5 listed)
- Diagnosed with clinically significant major congenital malformation
- Intestinal perforation or stage 2 necrotizing enterocolitis (NEC)
- Unlikely to survive the study period
- Receiving extended courses of antibiotics (most infants are expected to receive up to 48hr antibiotic prophylaxis at birth according to standard NICU protocol; this criterion will only exclude infants receiving prolonged courses of antibiotics)
- Presence prior to enrollment of intestinal perforation or stage 2 necrotizing enterocolitis (NEC) prior to tolerating fortified feeds
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 |
|---|---|---|
| Matched donor human milkMilk from donor mothers will be sorted according to their secretor status. This milk will be provided to infants in the intervention (experimental) arm. | Other | Matched donor human milk |
Primary outcome
Fecal microbiome composition
Time frame: sampled weekly until infant transferred from level III NICU, they are no longer receiving donor human milk or up to 60 days, whichever comes first.
16S RNA sequencing of fecal bacteria
Results and safety
The study was stopped early (reason given: A variety of feasibility issues. Could not recruit in a timely manner.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Background: PubMed 30247646Azad MB, Robertson B, Atakora F, Becker AB, Subbarao P, Moraes TJ, Mandhane PJ, Turvey SE, Lefebvre DL, Sears MR, Bode L. Human Milk Oligosaccharide Concentrations Are Associated with Multiple Fixed and Modifiable Maternal Characteristics, Environmental Factors, and Feeding Practices. J Nutr. 2018 Nov 1;148(11):1733-1742. doi: 10.1093/jn/nxy175.
- Background: PubMed 22513036Bode L. Human milk oligosaccharides: every baby needs a sugar mama. Glycobiology. 2012 Sep;22(9):1147-62. doi: 10.1093/glycob/cws074. Epub 2012 Apr 18.
- Background: PubMed 24282194Marx C, Bridge R, Wolf AK, Rich W, Kim JH, Bode L. Human milk oligosaccharide composition differs between donor milk and mother's own milk in the NICU. J Hum Lact. 2014 Feb;30(1):54-61. doi: 10.1177/0890334413513923. Epub 2013 Nov 26.
- Background: PubMed 29997594Parra-Llorca A, Gormaz M, Alcantara C, Cernada M, Nunez-Ramiro A, Vento M, Collado MC. Preterm Gut Microbiome Depending on Feeding Type: Significance of Donor Human Milk. Front Microbiol. 2018 Jun 27;9:1376. doi: 10.3389/fmicb.2018.01376. eCollection 2018.
- Background: PubMed 25922665Lewis ZT, Totten SM, Smilowitz JT, Popovic M, Parker E, Lemay DG, Van Tassell ML, Miller MJ, Jin YS, German JB, Lebrilla CB, Mills DA. Maternal fucosyltransferase 2 status affects the gut bifidobacterial communities of breastfed infants. Microbiome. 2015 Apr 10;3:13. doi: 10.1186/s40168-015-0071-z. eCollection 2015.
- Lab WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. At this time we plan to share IPD within our research team only. We will consider sharing with other researchers in the future
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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. This study is not recruiting at the moment.
Meghan B Azad, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Matched donor human milk in people with Microbial Colonization and Preterm Birth, run by University of Manitoba 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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 8 May 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?
The study was stopped early (reason given: A variety of feasibility issues. Could not recruit in a timely manner.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal microbiome composition (time frame: sampled weekly until infant transferred from level III NICU, they are no longer receiving donor human milk or up to 60 days, whichever comes first.). 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 NCT04130165, which also lists 5 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 8 May 2026.