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

NCT06970535 | Withdrawn

• 1 other identifier: 1000067542
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Breastmilk Collection; Childhood Obesity; Childhood Asthma; Allergy

Keywords

maternal metabolic status; term-born infants; breastmilk composition

Outcome Measures

Primary Outcomes (4)

• Breastmilk composition - Total Energy

  Total energy content of breastmilk samples measured using a mid-infrared human milk analyzer

  3-months postpartum

• Breastmilk composition - Macronutrients

  Macronutrient content of breastmilk samples (fat, protein \& carbohydrate) measured using a mid-infrared human milk analyzer

  3-months postpartum

• Breastmilk composition - Micronutrients

  Micronutrient content of breastmilk samples (examples include vitamin B12 and choline)

  3-months postpartum

• Breastmilk composition - Microbial profile

  Microbial profile of breastmilk samples using 16S rRNA gene sequencing and PCR amplification

  3-months postpartum

Secondary Outcomes (3)

• Child growth

  3-months postpartum to 5-years of age

• Childhood allergies

  3-months postpartum to 5-years of age

• Childhood asthma

  3-months postpartum to 5-years of age

Eligibility Criteria

• Age: 2 Months - 4 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Unity Health: collaborator
• University of Toronto: collaborator

Study Sites (2)

Unity Health Toronto

Toronto, Ontario, M5B 1W8, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 0A4, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Human breastmilk samples

MeSH Terms

Conditions

Breast Milk Expression; Pediatric Obesity; Hypersensitivity

Condition Hierarchy (Ancestors)

Breast Feeding; Feeding Behavior; Behavior; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Study Officials

• Deborah L O'Connor, PhD, RD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

• Catherine Birken, MD,MSc,FRCPC

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

• Jonathon Maguire, MD,MSc,FRCPC

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 14, 2025
• Study Start: September 15, 2021
• Primary Completion: January 11, 2026
• Study Completion: January 11, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)