Breastfeeding and Gut Health

NCT ID: NCT04195425

Last Updated: 2025-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-17

Study Completion Date

2031-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Gut Health

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Delphine Ley, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hop Jeanne de Flandre Chu Lille

Lille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Delphine Ley, MD

Role: CONTACT

03.20.44.50.72 ext. +33

Facility Contacts

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Role: primary

0320445962

References

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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.

Reference Type DERIVED
PMID: 34489289 (View on PubMed)

Other Identifiers

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2019-A01416-51

Identifier Type: OTHER

Identifier Source: secondary_id

2018_67

Identifier Type: -

Identifier Source: org_study_id

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