Clinical trial NCT04195425: Breastfeeding and Gut Health
Official title: Influence of Breastfeeding on Gut Health in Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gut Health
Keywords: breastfeeding
early nutrition
intestinal microbiota
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Monocentric cohort including mother/child dyads recruited in a University Maternity

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.


Eligibility criteria: 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

Primary outcomes:
measure: Correlation between exclusive breastfeeding and gut health based on the non-invasive measurement of fecal secretory immunoglobulin A (sIgA)
timeFrame: AT 4 years
Secondary outcomes:
measure: Correlation between gut health and the duration of exclusive breastfeeding
timeFrame: A 1 month, 1-2 months, 2-4 months, 4-6 months, 6 months
measure: Correlation between the mother's feeding habits during pregnancy and the child's gut health during the first 4 years of life
timeFrame: At 6 months, 2 years and 4 years
measure: Correlation between sIgA and child growth and gastro-intestinal disorders
timeFrame: At 6 months, 2 years and 4 years
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Jeanne de Flandre Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Delphine Ley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.