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RecruitingNCT04195425PENSINEUpdated Apr 7, 2026

Breastfeeding and Gut Health

An observational study in Gut Health, sponsored by University Hospital, Lille. Recruiting at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-07.

Sponsored by University Hospital, Lille · Observational

From the registry’s dates

  • Started Dec 2020; still recruiting 5 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Gut Health

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Keywords

  • breastfeeding
  • early nutrition
  • intestinal microbiota
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In context

Breast Feeding

262 studies on the registry are indexed under Breast Feeding; 112 are open to participants now.

This study's planned enrollment of 500 is above the median of 177 across 48 observational studies indexed under Breast Feeding.

Browse Breast Feeding studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Monocentric cohort including mother/child dyads recruited in a University Maternity

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
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What researchers measure

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

    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.

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

  2. 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

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

  3. 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.

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

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Study locations

1 of 1 sites recruiting
  • Hop Jeanne de Flandre Chu Lille
    Lille, 59037, France
    • · Contact · 0320445962
    • Delphine LEY, MD · Principal investigator
    Recruiting
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References and documents

Publications

  • 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. PubMed 34489289 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04195425
Lead sponsor
University Hospital, Lille
Responsible party
Sponsor
First posted
Dec 11, 2019
Start date
Dec 17, 2020
Primary completion
Jun 2031 (estimated)
Completion
Jun 2031 (estimated)
Last update
Apr 7, 2026

Study contacts

Delphine Ley, MD
Contact
delphine.ley@chru-lille.fr
03.20.44.50.72 ext. +33
Delphine Ley, MD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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