Gut HealthPENSINENCT04195425
Breastfeeding and Gut Health
An observational study of Gut Health, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gut Health
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 17 Dec 2020to Jun 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Monocentric cohort including mother/child dyads recruited in a University Maternity
Who may be able to join
- 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
Show all 9Show fewer
- For the father:
- Men >18 years old
- Informed consent
Who cannot join
- 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
Show all 9Show fewer
- Impossibility to participate to the study follow-up
- Child under judicial protection measure
- Child involved in another study inconsistent with biological samples collection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hop Jeanne de Flandre Chu Lille
Lille, 59037
0320445962
Delphine LEY, MD
About this study
Official title: Influence of Breastfeeding on Gut Health in Children
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.
- Conditions
- Gut Health
- Keywords
- breastfeeding, early nutrition, intestinal microbiota
- Medical subject headings
- Breast Feeding
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between exclusive breastfeeding and gut health based on the non-invasive measurement of fecal secretory immunoglobulin A (sIgA)
Measured: AT 4 years
Secondary outcomes (3)
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.
Measured: A 1 month, 1-2 months, 2-4 months, 4-6 months, 6 months
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
Measured: At 6 months, 2 years and 4 years
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.
Measured: At 6 months, 2 years and 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start17 Dec 2020
- Primary completionJun 2031 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gut HealthStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Delphine Ley, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195425
- Sponsor's protocol ID
- 2018_67
- Other IDs
- 2019-A01416-51
- Acronym
- PENSINE
- Status last verified
- Apr 2025
- First submitted
- 4 Dec 2019
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Breastfeeding on Gut Health in Children
- ClinicalTrials.gov ID
- NCT04195425
- Acronym / sponsor ID
- PENSINE / 2018_67
- Conditions
- Gut Health
- Keywords
- breastfeeding, early nutrition, intestinal microbiota
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- Jun 2031 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 11 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Monocentric cohort including mother/child dyads recruited in a University Maternity
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- Impossibility to participate to the study follow-up
- Woman under guardianship or curatorship
- Woman involved in another study inconsistent with biological samples collection
- Prematurity <37 weeks
- Impossibility to participate to the study follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between exclusive breastfeeding and gut health based on the non-invasive measurement of fecal secretory immunoglobulin A (sIgA)
Time frame: AT 4 years
3 secondary outcomes
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
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
Correlation between sIgA and child growth and gastro-intestinal disorders
Time frame: At 6 months, 2 years and 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Results publication: PubMed 34489289Ley 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Delphine Ley, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gut Health, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Delphine Ley, MD (03.20.44.50.72 ext. +33, delphine.ley@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between exclusive breastfeeding and gut health based on the non-invasive measurement of fecal secretory immunoglobulin A (sIgA) (time frame: AT 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04195425, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.