Breastfeeding and Gut Health

Gut Health Clinical Trial

— PENSINE  

Official title:

Influence of Breastfeeding on Gut Health in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04195425
• Other study ID #: 2018_67
• Secondary ID: 2019-A01416-51
• Status: Recruiting
• Start date: December 17, 2020
• Est. completion date: December 2025

Study information

• Verified date: June 2022
• Source: University Hospital, Lille
• Contact: Delphine Ley, MD
• Phone: 03.20.44.50.72
• Email: delphine.ley[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gut Health

Locations

Country	Name	City	State
France	Hop Jeanne de Flandre Chu Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between exclusive breastfeeding and gut health based on the non-invasive measurement of fecal secretory immunoglobulin A (sIgA)		AT 4 years
Secondary	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
Secondary	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
Secondary	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