Impact of breastfeeding on children's gut health
Influence of Breastfeeding on Gut Health in Children
University Hospital, Lille · NCT04195425
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 |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Lille (other) |
| Locations | 1 site (Lille) |
| Trial ID | NCT04195425 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Lille
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gut Health, breastfeeding, early nutrition, intestinal microbiota