Impact of early life nutrition on gut health in children: a prospective clinical study.
Delphine Ley, Laurent Beghin, Jules Morcel...
https://pubmed.ncbi.nlm.nih.gov/34489289Actively Recruiting
Age: 18Years +
FEMALE
ID04195425
Influence of Breastfeeding on Gut Health in Children
Led by University Hospital, Lille · Updated on 2026-04-07
500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how early nutrition affects gut health in children by following a group of newborns from birth up to 4 years old. The study aims to understand how breastfeeding and other feeding practices influence gut health, focusing on measuring fecal secretory immunoglobulin A (SIgA) and digestive symptoms. The study is observational and sponsored by the University Hospital, Lille. Participants include newborns whose parents provide information about their nutritional habits, breastfeeding duration, and complementary feeding. Biological samples such as cord blood cells and stool are collected at birth, 6 months, 2 years, and 4 years to build a biological collection. The study observes gut health over time and its relationship to early nutrition. During the study, children are regularly assessed for gut health markers and digestive symptoms. Researchers collect data on breastfeeding practices and maternal diet during pregnancy, as well as child growth and gastrointestinal issues. The primary outcome is the correlation between exclusive breastfeeding and gut health measured by fecal SIgA at 4 years. Secondary outcomes include correlations between gut health and breastfeeding duration, maternal feeding habits, and child growth. Participation lasts up to 4 years with multiple follow-up visits and sample collections.
CONDITIONS
Brief Title
Breastfeeding and Gut Health
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Pregnant woman over 18 years old followed at Lille University Jeanne de Flandres Maternity
- Woman who can speak, read, and write in French
- Single pregnancy
- Informed consent provided
- Living in the Lille area
- Men over 18 years old
- Informed consent provided by father
You will not qualify if you...
- Inability of the mother to participate in the study follow-up
- Woman under guardianship or curatorship
- Woman involved in another study conflicting with biological sample collection
- Child born prematurely before 37 weeks
- Inability of the child to participate in the study follow-up
- Child under judicial protection
- Child involved in another study conflicting with biological sample collection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Sample Collection
Duration - From birth up to 4 years
Participants provide biological samples to assess gut health and other related measures during early childhood.
Visits at 1 month, 1-2 months, 2-4 months, 4-6 months, 6 months, 2 years, and 4 years
Long-term Monitoring
Duration - Up to 4 years
Participants are observed over the first 4 years of the child's life to monitor gut health and growth outcomes.
Periodic assessments at 6 months, 2 years, and 4 years
Trial Site Locations
Total: 1 location
1
Hop Jeanne de Flandre Chu Lille
Lille, France, 59037
Actively Recruiting
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Research Team
D
Delphine Ley, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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