Skip to content

Intestinal microbiota composition after antibiotic treatment in early life

Intestinal microbiota composition after antibiotic treatment in early life - The INCA study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON46989
Enrollment
450
Registered
2011-10-11
Start date
2012-01-11
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

composition of intestinal microbiota development of allergy

Interventions

None listed

Sponsors

Sint Antonius Ziekenhuis
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

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

Exclusion criteria: Prematurity (i.e. gestational age

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)