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NCT Number: NCT04195425

Breastfeeding and Gut Health

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.

Recruiting

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Key information

Conditions

Gut Health Behavior Breast Feeding Feeding Behavior

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hop Jeanne de Flandre Chu Lille

Lille, 59037, France

Location status: Recruiting

Location contact

Delphine LEY, MD

PRINCIPAL_INVESTIGATOR

CONTACT

0320445962

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Correlation between exclusive breastfeeding and gut health based on the non-invasive measurement of fecal secretory immunoglobulin A (sIgA)

    Time frame: AT 4 years

Secondary outcomes

  1. Correlation between gut health and the duration of exclusive breastfeeding

    Time frame: A 1 month, 1-2 months, 2-4 months, 4-6 months, 6 months

    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.

  2. Correlation between the mother's feeding habits during pregnancy and the child's gut health during the first 4 years of life

    Time frame: At 6 months, 2 years and 4 years

    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

  3. Correlation between sIgA and child growth and gastro-intestinal disorders

    Time frame: At 6 months, 2 years and 4 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Delphine Ley, MD

CONTACT

[email protected]

03.20.44.50.72 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Influence of Breastfeeding on Gut Health in Children

Acronym: PENSINE

Important dates

Study start
2020
Primary completion
2031
Study completion
2031
First posted
Dec 11, 2019
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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