Breastfeeding and Gut Health
ConditionGut Health
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity Hospital, Lille
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Monocentric cohort including mother/child dyads recruited in a University Maternity
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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 yearsSecondary 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 months2
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 years3
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 yearsSponsors and contacts
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Source ClinicalTrials.gov