Impact of breastfeeding on children's gut health
Official title: Influence of Breastfeeding on Gut Health in Children
Run by University Hospital, Lille · NCT04195425 · Data updated 2026-11-12
This study is trying to see how breastfeeding and early nutrition affect gut health in children from birth to four years old.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 500 (estimated) |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lille) |
| Status | Recruiting |
| Started | December 17, 2020 |
| Main results expected | June 2031 |
| Study ends | June 2031 |
| Registry record updated | April 7, 2026 |
| Trial ID | NCT04195425 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pregnant women over 18 years old who are residents of the Lille area and can provide informed consent.
✕Probably not a fit
Patients who may not benefit from this study include those with premature infants or those unable to participate in the follow-up assessments.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate how early nutrition, particularly breastfeeding, affects gut health in children from birth to four years of age. A cohort of newborns will be recruited at birth, with data collected on parental nutritional habits, breastfeeding duration, and complementary feeding practices. Biological samples, including cord blood and stool, will be collected at various intervals to assess gut health through fecal secretory immunoglobulin A (SIgA) levels and digestive symptoms. The study seeks to provide detailed insights into the relationship between breastfeeding practices and gut health outcomes in early childhood.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into how breastfeeding influences gut health, potentially guiding nutritional recommendations for infants.
How similar studies have gone: While there have been studies on breastfeeding and gut health, this specific approach focusing on long-term follow-up and biological sample collection is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: For the mother: * Pregnant woman (\>18 years old) followed at the Lille University Jeanne de Flandres Maternity * Woman who can speak, read and write in French * Single pregnancy * Informed consent * Living in the Lille area For the father: * Men \>18 years old * Informed consent Exclusion Criteria: For the mother: * Impossibility to participate to the study follow-up * Woman under guardianship or curatorship * Woman involved in another study inconsistent with biological samples collection For the child after birth: * Prematurity \<37 weeks * Impossibility to participate to the study follow-up * Child under judicial protection measure * Child involved in another study inconsistent with biological samples collection
Where it's running
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Hop Jeanne de Flandre Chu Lille
Lille, France Recruiting
Study contacts
- Principal investigator: Delphine Ley, MD — University Hospital, Lille
- Study coordinator: Delphine Ley, MD
- Email: delphine.ley@chru-lille.fr
- Phone: 03.20.44.50.72
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.