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WithdrawnNo phase

Breastmilk Composition and Microbial Profile in the Growth and Development of Healthy Term-born Infants

Reason given: Pandemic related complications made the study no longer feasible.

Key facts

Where
Toronto, CanadaSee the 2 sites

Where in Canada

  • The Hospital for Sick ChildrenToronto, CanadaNo longer taking part
  • Unity Health TorontoToronto, CanadaNo longer taking part

Trial details

Who runs it
The Hospital for Sick Children
Trial code
NCT06970535
Record updated
14 May 2025
Original description
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 full original descriptionShow less

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.

Inclusion: 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.

Exclusion: 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 child was born at <37 weeks gestation; The family of the child is unable to communicate in English.

ClinicalTrials.gov NCT06970535