Breastfeeding and Gut Health

Recruiting

• Conditions: Gut Health

• Registration Number: NCT04195425
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-04
• Study First Submitted QC: 2019-12-10
• Study First Posted: 2019-12-11
• Study Start: 2020-12-17
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-27
• Primary Completion: 2031-06
• Study Completion: 2031-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between exclusive breastfeeding and gut health based on the non-invasive measurement of fecal secretory immunoglobulin A (sIgA)	AT 4 years

Secondary Outcome Measures

Name	Time	Method
Correlation between gut health and the duration of exclusive breastfeeding	A 1 month, 1-2 months, 2-4 months, 4-6 months, 6 months	defined by the production of Igas in the faeces and the duration of exclusive breastfeeding (1 month, 1-2 months, 2-4 months, 4-6 months, 6 months) collected by mother's interrogation.
Correlation between sIgA and child growth and gastro-intestinal disorders	At 6 months, 2 years and 4 years	defined by Production of Igas in children and the head circumference, weight and height of the child reported in the health log and the presence of gastrointestinal symptoms evaluated according to the criteria of ROME IV.
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	Nutritional data collected via the Food Frequency Questionnaire (FFQ) and the mother's obstetric record and Intestinal health of the child during the first 4 years of life evaluated by the production of Igas

Trial Locations

Locations (1)

Hop Jeanne de Flandre Chu Lille; 🇫🇷 Lille, France