MedTrace Logo

The Investigation of Methods to Capture Acute Respiratory and Gastrointestinal Infections of Children Aged 1 to 3 Years

NCT02081833 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2016-01-12

No results posted yet for this study

Summary

This study serves as a feasibility study for a birth cohort study to investigate the influence of the sequence and load of infections and vaccinations on the development of the immune system of children. In this study, the investigators aim to test the methods developed to capture acute respiratory and gastrointestinal infections and their consequences of children aged 1 to 3 years in Braunschweig, Germany. Furthermore, the investigators want to study the influence of the environment on the microbiome of children by comparing children of the same child care centre with children from different child care centres. The methods developed include a symptom diary which has to be filled out on a daily basis by the parents. Furthermore parents are asked to take monthly anterior nasal swabs and stool samples from the study child independent from symptoms as well as one sample if symptoms occur. The parents are provided with instructions and the first nasal swab will be demonstrated by trained study personal. The study is powered to compare nasal swabs taken by the trained staff and the parents as primary outcome. Secondary outcome is the performance of reminders sent to the study participants. The diary and the specimen will be mailed to the Helmholtz Centre for Infection Research where they will be analyzed for the nasal and gut microbiome. The nasal swabs taken at the time of an infection will be tested for respiratory viruses. After the study period of 3 months parents will be asked about the feasibility and acceptance of the symptom diary and taking the nasal swabs and stool specimens by means of questionnaires and interviews (face to face and focus groups). This will help our understanding of the feasibility and acceptance of the methods developed to capture acute respiratory and gastrointestinal infections of children and our understanding of the development and composition of the nasal and gut microbiota.

Conditions

  • Childhood Infections

Sponsors & Collaborators

  • Helmholtz Centre for Infection Research

    lead OTHER

Principal Investigators

  • Rafael Mikolajczyk, MD, MSc · Helmholtz Centre for Infection Research

  • André Karch, MD, MSc · Helmholtz Centre for Infection Research

  • Beate Zoch, MSc · Helmholtz Centre for Infection Research

Eligibility

Min Age
1 Year
Max Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02081833 on ClinicalTrials.gov