Breastmilk Composition and Microbial Profile in the Growth and Development of Healthy Term-born I… (NCT06970535) | Clinical Trial Compass
WithdrawnNot Applicable
Breastmilk Composition and Microbial Profile in the Growth and Development of Healthy Term-born Infants
Stopped: Pandemic related complications made the study no longer feasible.
Canada0Started 2021-09-15
Plain-language 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. 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.
Who can participate
Age range
2 Months – 4 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.