Eczema Clinical Trial
Official title:
"Intestinal Microbiota Composition After Antibiotic Treatment in Early Life. The INCA Study"
In this prospective observational cohort study the potential clinical consequences of
antibiotic use in early life and perturbations in the gastrointestinal microbiota
composition due to that antibiotic use are studied. It is hypothesized that altered
microbiota may be an important underlying mechanism for impediments in the developing immune
system.
Differentiation will be made between a group of neonates who received antibiotics in the
first week of life, and control infants who were not exposed to antibiotics in the neonatal
period.
Healthy newborns born in the hospital, observed for low probability of neonatal infection
will be compared to newborns exposed to antibiotic therapy in early life (first 1-2 weeks).
Infants are recruited from the maternity wards and neonatal wards of four teaching hospitals
in the Netherlands. In total 150 infants, treated with antibiotics because of (a high
suspicion of) a perinatal infection during the first week of life, will be recruited. The
control group comprises 300 healthy newborns, born in the hospital and needing clinical
observation for 24-48 hours for several reasons like maternal comorbidity, low probability
of neonatal infection, blood sugar monitoring, meconium containing amniotic fluid, or
delivery by caesarean section.
Differences in clinical outcomes between antibiotic treated infants and controls are
investigated. Incidence of atopic dermatitis (eczema), food allergy, upper respiratory tract
infections (URTI), lower respiratory tract infections (LRTI), gastrointestinal infections
(GITI) and excessive crying are evaluated, prospectively assessed by parental reports and
retrospectively assessed by doctor's diagnoses. The clinical endpoints will be linked to the
developing intestinal microbiota during the first year of life.
Potential differences in intestinal fecal microbiota composition and diversity can be
determined at eight time points during the first year of life, as sampling moments include:
day one (T1), day two (T2), one week (T3), two weeks (T4), one month (T5), three months
(T6), six months (T7), one year (T8).
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Observational Model: Cohort, Time Perspective: Prospective
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