Childhood Infections Clinical Trial
Official title:
The Investigation of Methods to Capture Acute Respiratory and Gastrointestinal Infections of Children Aged 1 to 3 Years. Feasibility Study for the Braunschweig Birth Cohort LöwenKIDS (Infections and the Development of the Immune System)
| Verified date | January 2016 |
| Source | Helmholtz Centre for Infection Research |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Ethics Commission |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 75 |
| Est. completion date | June 2014 |
| Est. primary completion date | June 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 1 Year to 3 Years |
| Eligibility |
Inclusion Criteria: - written informed consent from both parents or legal guardians - child below the age of three visiting a CCC in Braunschweig, Germany - parents or guardian with sufficient German language skills to complete study diaries and perform study tasks as required Exclusion Criteria: |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | Helmholtz Centre for Infection Research | Braunschweig | Lower Saxony |
| Lead Sponsor | Collaborator |
|---|---|
| Helmholtz Centre for Infection Research |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Feasibility and acceptance of taking nasal swabs and stool samples by parents of their child | Feasibility and acceptance of taking nasal swabs and stool samples by parents of their child measured by: the comparison of quality of nasal swab taken by trained study personal and swab taken by parents (ß-actin and 16s rRNA) the number of samples sent back the feedback by parents (by quantitative and qualitative methods) |
after 3 months | No |
| Secondary | Composition of faecal and nasal microbiome | Similarity of the faecal and nasal microbiome among children from one child care centre | at baseline | No |