Breastfeeding and Gut Health

NCT04195425 | Recruiting

• 2 other identifiers: 2018_672019-A01416-51
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Gut Health

Keywords

breastfeeding; early nutrition; intestinal microbiota

Outcome Measures

Primary Outcomes (1)

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

  AT 4 years

Secondary Outcomes (3)

• 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 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

• Correlation between sIgA and child growth and gastro-intestinal disorders

  At 6 months, 2 years and 4 years

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant woman
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Monocentric cohort including mother/child dyads recruited in a University Maternity

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hop Jeanne de Flandre Chu Lille

Lille, 59037, France

RECRUITING

Related Publications (1)

• Ley D, Beghin L, Morcel J, Flamein F, Garabedian C, Accart B, Drumez E, Labreuche J, Gottrand F, Hermann E. Impact of early life nutrition on gut health in children: a prospective clinical study. BMJ Open. 2021 Sep 6;11(9):e050432. doi: 10.1136/bmjopen-2021-050432.

  PMID: 34489289 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Cord blood mononuclear cells, meconium/stools

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Delphine Ley, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Delphine Ley, MD

CONTACT

03.20.44.50.72; delphine.ley@chru-lille.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 11, 2019
• Study Start: December 17, 2020
• Primary Completion (Estimated): June 1, 2031
• Study Completion (Estimated): June 1, 2031
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

FR (1)