Breastfeeding and Gut Health (PENSINE)

Influence of Breastfeeding on Gut Health in Children

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.

Study Overview

• Status: Recruiting
• Conditions: Gut Health

• Study Type: Observational
• Enrollment (Anticipated): 350

Contacts and Locations

• Study Contact: Name: Delphine Ley, MD; Phone Number: +33 03.20.44.50.72; Email: delphine.ley@chru-lille.fr

Study Locations

• France
  • Lille, France, 59037
    • Recruiting
    • Hop Jeanne de Flandre Chu Lille
    • Principal Investigator: Delphine LEY, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Correlation between gut health and the duration of exclusive breastfeeding	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.	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	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	At 6 months, 2 years and 4 years
Correlation between sIgA and child growth and gastro-intestinal disorders	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.	At 6 months, 2 years and 4 years

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Delphine Ley, MD, University Hospital, Lille

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2020
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: December 4, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (Actual): December 11, 2019

Study Record Updates

• Last Update Posted (Actual): July 6, 2022
• Last Update Submitted That Met QC Criteria: July 4, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: breastfeeding; intestinal microbiota; early nutrition
• Other Study ID Numbers: 2018_67; 2019-A01416-51 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No