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Clinical Trials/NCT04195425
NCT04195425
Recruiting
Not Applicable

Influence of Breastfeeding on Gut Health in Children

University Hospital, Lille1 site in 1 country500 target enrollmentDecember 17, 2020
ConditionsGut Health

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gut Health
Sponsor
University Hospital, Lille
Enrollment
500
Locations
1
Primary Endpoint
Correlation between exclusive breastfeeding and gut health based on the non-invasive measurement of fecal secretory immunoglobulin A (sIgA)
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The aim of the study is to evaluate the impact of early nutrition on gut health in children. A prospective cohort of newborns will be recruited at birth and followed up to 4 years of age. Information on parent's nutritional habits and life style, breastfeeding duration and child's complementary feeding, will be collected. Cord blood cells and stools will be collected at birth, 6 months, 2 years and 4 years of age for implementing a biological collection. Gut health will be evaluated in children during the first four years of life based on fecal secretory immunoglobulin A (SIgA) and presence of digestive symptoms. Precise data on breastfeeding practices and their short- and medium-term effects on the health of the child, in particular and in an innovative way on gut health, will be obtained.

Registry
clinicaltrials.gov
Start Date
December 17, 2020
End Date
June 2031
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Sponsor
University Hospital, Lille
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Correlation between exclusive breastfeeding and gut health based on the non-invasive measurement of fecal secretory immunoglobulin A (sIgA)

Time Frame: AT 4 years

Secondary Outcomes

  • Correlation between gut health and the duration of exclusive breastfeeding(A 1 month, 1-2 months, 2-4 months, 4-6 months, 6 months)
  • Correlation between sIgA and child growth and gastro-intestinal disorders(At 6 months, 2 years and 4 years)
  • Correlation between the mother's feeding habits during pregnancy and the child's gut health during the first 4 years of life(At 6 months, 2 years and 4 years)

Study Sites (1)

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