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

Withdrawn

• Conditions: Breastmilk Collection; Childhood Asthma; Childhood Obesity; Allergy

• Registration Number: NCT06970535
• Lead Sponsor: The Hospital for Sick Children

Brief 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.

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:

1. 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).

2. To assess the associations between breastmilk composition and obesity, asthma and allergy in the children longitudinally to five years of age.

Study Timeline

• Study Start: 2021-09-15
• Status Verified: 2025-05
• Study First Submitted: 2025-05-06
• Study First Submitted QC: 2025-05-06
• Last Update Submitted: 2025-05-06
• Study First Posted: 2025-05-14
• Last Update Posted: 2025-05-14
• Primary Completion: 2026-01-11
• Study Completion: 2026-01-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Breastmilk composition - Total Energy	3-months postpartum	Total energy content of breastmilk samples measured using a mid-infrared human milk analyzer
Breastmilk composition - Macronutrients	3-months postpartum	Macronutrient content of breastmilk samples (fat, protein \& carbohydrate) measured using a mid-infrared human milk analyzer
Breastmilk composition - Micronutrients	3-months postpartum	Micronutrient content of breastmilk samples (examples include vitamin B12 and choline)
Breastmilk composition - Microbial profile	3-months postpartum	Microbial profile of breastmilk samples using 16S rRNA gene sequencing and PCR amplification

Secondary Outcome Measures

Name	Time	Method
Child growth	3-months postpartum to 5-years of age	Weight and length/height measured at well-child visits to calculate BMI age- and sex-specific z-scores, annually until 5-years of age
Childhood allergies	3-months postpartum to 5-years of age	Measured by parental-report via questionnaire at well-child visits annually until 5-years of age
Childhood asthma	3-months postpartum to 5-years of age	Measured by parental report via questionnaire at well-child visits annually until 5-years of age

Trial Locations

Locations (2)

Unity Health Toronto; 🇨🇦 Toronto, Ontario, Canada

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada