Breastfeeding and Gut Health (PENSINE)

University Hospital, Lille

Status: Enrolling

Conditions: Gut Health

Study type: Observational

Funder types: Other

Identifiers

NCT04195425

2019-A01416-51 (Other Identifier)

2018_67

Details and patient eligibility

About

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.

Enrollment: 350 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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