Breastmilk CollectionNCT06970535
Breastmilk Composition and Microbial Profile in the Growth and Development of Healthy Term-born Infants
An observational study of Breastmilk Collection and Childhood Obesity, run by The Hospital for Sick Children at 2 sites in Canada.
Trial summary
An increasing number of children are developing non-communicable diseases that carry immediate and long-term significant societal and economic impacts. Thus, its prevention is imperative with early interventions, such as those that may fall within the first 1000 days, likely to yield better outcomes. Read more about this study
- Who is it for?
- Ages 2 to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Breastmilk Collection, Childhood Obesity, Childhood Asthma
- How many people
- 0 participants
- Where
- 2 sitesCanada
- Study dates
- 15 Sep 2021to 11 Jan 2026
- Phase
- Observational
- 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 2 to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Mother-infant dyads will be recruited prospectively within the TARGet Kids! cohort. According to current TARGet Kids! study procedures (NCT01869530), initial contact with families is made by email or letter, from the child's paediatric clinic, two weeks prior to the scheduled visit. Families will also be made aware of the study through posters and informal conversations during early postnatal well-child visits.
Who may be able to join
- The child is a participant in the TARGet Kids! (The Applied Research Group for Kids) study (NCT01869530)
- The child is between two and four months of age at recruitment.
- The child is healthy.
- Child is fed exclusively mother's milk and has not received any infant formula, cow's milk, juice, tea, or solids in the two weeks prior to recruitment.
- The mother of the child is present at the time of recruitment.
Who cannot join
- The child was born at <37 weeks gestation.
- The child has been diagnosed with a health condition affecting growth (e.g. failure to thrive, cystic fibrosis).
- The child has been diagnosed with any acute or chronic conditions.
- The family of the child is unable to communicate in English.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Unity Health Toronto
Toronto, Ontario, M5B 1W8
The Hospital for Sick Children
Toronto, Ontario, M5G 0A4
About this study
An increasing number of children are developing non-communicable diseases that carry immediate and long-term significant societal and economic impacts. Thus, its prevention is imperative with early interventions, such as those that may fall within the first 1000 days, likely to yield better outcomes. The first 1000 days of life represent a period of rapid development sensitive to influences that may be leveraged to promote healthy growth. Breastfeeding is one such modifiable factor. Observational studies have shown that breastfeeding may be associated with reductions in chronic conditions, though its mechanism remains unknown. The complexity of these relationships is furthered by studies showing maternal metabolic status may alter breastmilk composition. Accordingly, this study aims to evaluate the influence of maternal metabolic status on breastmilk composition and assess associations between breastmilk composition and common noncommunicable diseases in childhood.
Read the detailed description
This project will be completed within TARGet Kids! (The Applied Research Group for Kids), a paediatric primary care research network (NCT01869530). Mother-infant dyads will be recruited and a breastmilk sample obtained at three months of age. Children will then be seen as part of routine care for the next five years to track growth, health and development. This study will provide the opportunity of prospectively following term-born Canadian children to understand the relationship between breastfeeding patterns and child health, its potential underlying mechanisms and how breastmilk composition is modified by maternal metabolic status, which altogether can be used to help set children on optimal developmental trajectories.
STUDY OBJECTIVES:
- To evaluate the influence of maternal metabolic status, on breastmilk composition (energy, macronutrient and micronutrient content and microbial profile) at three months post-partum.
- Maternal metabolic status will be characterized by: maternal obesity (measured), diabetes, hypertension and gestational weight gain (self-reported).
- To assess the associations between breastmilk composition and obesity, asthma and allergy in the children longitudinally to five years of age.
- Conditions
- Breastmilk Collection, Childhood Obesity, Childhood Asthma, Allergy
- Keywords
- maternal metabolic status, term-born infants, breastmilk composition
- Medical subject headings
- Breast Milk Expression, Pediatric Obesity, Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastmilk composition - Total Energy
Total energy content of breastmilk samples measured using a mid-infrared human milk analyzer
Measured: 3-months postpartum
Breastmilk composition - Macronutrients
Macronutrient content of breastmilk samples (fat, protein \& carbohydrate) measured using a mid-infrared human milk analyzer
Measured: 3-months postpartum
Breastmilk composition - Micronutrients
Micronutrient content of breastmilk samples (examples include vitamin B12 and choline)
Measured: 3-months postpartum
Breastmilk composition - Microbial profile
Microbial profile of breastmilk samples using 16S rRNA gene sequencing and PCR amplification
Measured: 3-months postpartum
Secondary outcomes (3)
Child growth
Weight and length/height measured at well-child visits to calculate BMI age- and sex-specific z-scores, annually until 5-years of age
Measured: 3-months postpartum to 5-years of age
Childhood allergies
Measured by parental-report via questionnaire at well-child visits annually until 5-years of age
Measured: 3-months postpartum to 5-years of age
Childhood asthma
Measured by parental report via questionnaire at well-child visits annually until 5-years of age
Measured: 3-months postpartum to 5-years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start15 Sep 2021 (estimated)
- Primary completion11 Jan 2026 (estimated)
- Study completion11 Jan 2026 (estimated)
Why it stopped: Pandemic related complications made the study no longer feasible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breastmilk CollectionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Unity Health, University of Toronto
- Responsible party
- Principal investigator, Deborah O'Connor, The Hospital for Sick Children
- Investigators
- Deborah L O'Connor, PhD, RD, Principal investigator, The Hospital for Sick ChildrenCatherine Birken, MD,MSc,FRCPC, Principal investigator, The Hospital for Sick ChildrenJonathon Maguire, MD,MSc,FRCPC, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970535
- Sponsor's protocol ID
- 1000067542
- Status last verified
- May 2025
- First submitted
- 6 May 2025
- Last updated
- 14 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breastmilk Composition and Microbial Profile in the Growth and Development of Healthy Term-born Infants
- ClinicalTrials.gov ID
- NCT06970535
- Acronym / sponsor ID
- 1000067542
- Conditions
- Breastmilk Collection, Childhood Obesity, Childhood Asthma, Allergy
- Keywords
- maternal metabolic status, term-born infants, breastmilk composition
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Pandemic related complications made the study no longer feasible.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Unity Health, University of Toronto
- Study start
- 15 Sep 2021 (estimated)
- Primary completion
- 11 Jan 2026 (estimated)
- Study completion
- 11 Jan 2026 (estimated)
- First posted
- 14 May 2025 (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.
An increasing number of children are developing non-communicable diseases that carry immediate and long-term significant societal and economic impacts. Thus, its prevention is imperative with early interventions, such as those that may fall within the first 1000 days, likely to yield better outcomes. The first 1000 days of life represent a period of rapid development sensitive to influences that may be leveraged to promote healthy growth. Breastfeeding is one such modifiable factor. Observational studies have shown that breastfeeding may be associated with reductions in chronic conditions, though its mechanism remains unknown. The complexity of these relationships is furthered by studies showing maternal metabolic status may alter breastmilk composition. Accordingly, this study aims to evaluate the influence of maternal metabolic status on breastmilk composition and assess associations between breastmilk composition and common noncommunicable diseases in childhood.
Detailed description
This project will be completed within TARGet Kids! (The Applied Research Group for Kids), a paediatric primary care research network (NCT01869530). Mother-infant dyads will be recruited and a breastmilk sample obtained at three months of age. Children will then be seen as part of routine care for the next five years to track growth, health and development. This study will provide the opportunity of prospectively following term-born Canadian children to understand the relationship between breastfeeding patterns and child health, its potential underlying mechanisms and how breastmilk composition is modified by maternal metabolic status, which altogether can be used to help set children on optimal developmental trajectories.
STUDY OBJECTIVES:
- To evaluate the influence of maternal metabolic status, on breastmilk composition (energy, macronutrient and micronutrient content and microbial profile) at three months post-partum.
- Maternal metabolic status will be characterized by: maternal obesity (measured), diabetes, hypertension and gestational weight gain (self-reported).
- To assess the associations between breastmilk composition and obesity, asthma and allergy in the children longitudinally to five years of age.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Mother-infant dyads will be recruited prospectively within the TARGet Kids! cohort. According to current TARGet Kids! study procedures (NCT01869530), initial contact with families is made by email or letter, from the child's paediatric clinic, two weeks prior to the scheduled visit. Families will also be made aware of the study through posters and informal conversations during early postnatal well-child visits.
Key inclusion criteria (5 listed)
- The child is a participant in the TARGet Kids! (The Applied Research Group for Kids) study (NCT01869530)
- The child is between two and four months of age at recruitment.
- The child is healthy.
- Child is fed exclusively mother's milk and has not received any infant formula, cow's milk, juice, tea, or solids in the two weeks prior to recruitment.
- The mother of the child is present at the time of recruitment.
Key exclusion criteria (4 listed)
- The child was born at <37 weeks gestation.
- The child has been diagnosed with a health condition affecting growth (e.g. failure to thrive, cystic fibrosis).
- The child has been diagnosed with any acute or chronic conditions.
- The family of the child is unable to communicate in English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Breastmilk composition - Total Energy
Time frame: 3-months postpartum
Total energy content of breastmilk samples measured using a mid-infrared human milk analyzer
Breastmilk composition - Macronutrients
Time frame: 3-months postpartum
Macronutrient content of breastmilk samples (fat, protein \& carbohydrate) measured using a mid-infrared human milk analyzer
Breastmilk composition - Micronutrients
Time frame: 3-months postpartum
Micronutrient content of breastmilk samples (examples include vitamin B12 and choline)
Breastmilk composition - Microbial profile
Time frame: 3-months postpartum
Microbial profile of breastmilk samples using 16S rRNA gene sequencing and PCR amplification
3 secondary outcomes
Child growth
Time frame: 3-months postpartum to 5-years of age
Childhood allergies
Time frame: 3-months postpartum to 5-years of age
Childhood asthma
Time frame: 3-months postpartum to 5-years of age
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No
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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.
Deborah L O'Connor, PhD, RD principal investigator
The Hospital for Sick Children
Catherine Birken, MD,MSc,FRCPC principal investigator
The Hospital for Sick Children
Jonathon Maguire, MD,MSc,FRCPC principal investigator
Unity Health Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breastmilk Collection and Childhood Obesity, run by The Hospital for Sick Children at 2 sites 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 5 inclusion and 4 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: withdrawn, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 withdrawn before enrolling participants, so there are no results.
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?
Breastmilk composition - Total Energy (time frame: 3-months postpartum). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2025.