LoewenKIDS - Infections and the Development of the Immune System

Study Overview
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Brief Summary
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The purpose of this study is to determine in what way infections, microbiome, and vaccinations during childhood interact in shaping the development of immunity and tolerance. The investigators collect and use data from a birth cohort focusing on infectious diseases during childhood and apply a life course perspective.

Detailed Description
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The goal of the study is to capture the complete history of exposure towards microbial challenges in the first six years of life and to study interactions between different components of microbial exposure as well as effects on the development of immunity. The investigators apply a diary in which parents document symptoms of respiratory and gastrointestinal infections of their child, and collect nasal swabs and stool samples obtained on first day of symptoms. In addition, the investigators collect nasal swabs and stool samples once per year during an asymptomatic period. The investigators intend to collect venous blood from children participating in the study at the age of six years. In a subsample (called intensive subcohort), the investigators collect asymptomatic probes three monthly during the first two years of life and obtain venous blood of the children at the age of one and two years. The study sample is 782 participants, with 285 participants in the intensive subcohort. Symptomatic samples will be analyzed by means of multiplex polymerase chain reaction (PCR). In addition, the investigators will assess microbial compositions based on next generation sequencing and apply multiplex panels to study parameters of unspecific humoral immune response. The study will allow to assess homologous and heterologous effects of infections and vaccinations measuring specific humoral immune response. In collaboration with immunologists, immune phenotypes will be studied and functional tests will be conducted. The investigators will use allergic dermatitis at the age of two as a primary proxy outcome and target asthma at the age of six years as a definitive clinical endpoint.

Official Title
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LoewenKIDS - Infections and the Development of the Immune System

Conditions
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Infectious Diseases

Intervention / Treatment
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* Other: No Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: newborn in a study region Exclusion Criteria: parents < 18 years old insufficient knowledge of the German language (parents)

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No Intervention|No Intervention|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of immune system | Assessment of interactions between infections, microbial colonization, vaccinations and immune response in the framework of life-course epidemiology | 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Allergic dermatitis (yes/no) | Mechanisms of microbial challenge underlying the development of atopic dermatitis in the framework of life-course epidemiology | at age of two years | 
| Asthma | Mechanisms of microbial challenge underlying the development of asthma in the framework of life-course epidemiology | at age of six years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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birth cohort, infectious diseases, microbiome, immune system, immune response