Intestinal microbiota composition after antibiotic treatment in early life

Recruiting

Conditions: composition of intestinal microbiota
development of allergy
10017943
10001708
10024970

Registration Number: NL-OMON46989

Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 450

Inclusion Criteria

Term born babies (i.e. > 36 weeks gestational age)
(Short) stay on maternal ward OR admission to neonatal ward because of antibiotic treatment
Signed informed consent by the parents

Exclusion Criteria

Prematurity (i.e. gestational age < 36 weeks)
Congenital illness or malformations
Maternal probiotic use (well considered) < last 6 weeks of pregnancy
Severe perinatal infections for which neonatal intensive care transfer is needed
Insufficient knowledge of the Ducht language (by the parents)

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of the study is the incidence of eczema in antibiotic<br /><br>treated children versus healthy controls. Besides that, the incidence of food<br /><br>allergy, URTI, LRTI and GITI will be monitored. This will illustrate whether<br /><br>early antibiotic treatment may influence the developing immune system.<br /><br>Objective evaluation will be done by measuring vaccination response, length and<br /><br>weight (weight/growth curves) and recall doctors diagnoses from the GP<br /><br>(primary care visits for URTI, LRTI, GITI, food allergy, atopic dermatitis).<br /><br>Even so, usage of medication will be determined by checking pharmacists<br /><br>medication records and by asking the parents to report antibiotic treatment of<br /><br>their child on the monthly checklists. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secundary outcomes of the study are potential differences in the<br /><br>development of intestinal microbiota (i.e. microbiota composition) in infants<br /><br>exposed to antibiotic therapy in early life (first 2 weeks) versus infants that<br /><br>did not receive antibiotic treatment during that period.<br /><br><br /><br>The samples are subjected to microbiota composition profiling by means of a<br /><br>PCR-based interspace profiling technique (IS-pro, IS-Disgnostics, Amsterdam).<br /><br>Composition of faecal samples will be analyzed by targeting bacterial groups<br /><br>that are present (e.g. Bifidobacteria, Enterobacteriaceae, Streptococci,<br /><br>Lactobacilli, Bacteroides, Proteobacteria) and by pyrosequencing technique at<br /><br>the University of Wageningen (head Prof. J. Knol). . </p><br>