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Breastfeeding and Gut Health

Influence of Breastfeeding on Gut Health in Children

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04195425
Acronym
PENSINE
Enrollment
500
Registered
2019-12-11
Start date
2020-12-17
Completion date
2031-06-01
Last updated
2026-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gut Health

Keywords

breastfeeding, early nutrition, intestinal microbiota

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.

Interventions

None listed

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Correlation between exclusive breastfeeding and gut health based on the non-invasive measurement of fecal secretory immunoglobulin A (sIgA)AT 4 years

Secondary

MeasureTime frameDescription
Correlation between gut health and the duration of exclusive breastfeedingA 1 month, 1-2 months, 2-4 months, 4-6 months, 6 monthsdefined 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.
Correlation between the mother's feeding habits during pregnancy and the child's gut health during the first 4 years of lifeAt 6 months, 2 years and 4 yearsNutritional 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
Correlation between sIgA and child growth and gastro-intestinal disordersAt 6 months, 2 years and 4 yearsdefined 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.

Countries

France

Contacts

CONTACTDelphine Ley, MD
delphine.ley@chru-lille.fr03.20.44.50.72
PRINCIPAL_INVESTIGATORDelphine Ley, MD

University Hospital, Lille

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026