Breastfeeding and Gut Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Gut Health. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Influence of Breastfeeding on Gut Health in Children
Overview
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.
Primary outcome measures
- 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 outcome measures (3)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Hop Jeanne de Flandre Chu Lille — Lille
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. PMID 34489289
Identifiers
NCT: NCT04195425 · 2018_67 · 2019-A01416-51