LoewenKIDS - Infections and the Development of the Immune System (LoewenKIDS)
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|ClinicalTrials.gov Identifier: NCT02654210|
Recruitment Status : Recruiting
First Posted : January 13, 2016
Last Update Posted : August 24, 2017
|Condition or disease||Intervention/treatment|
|Infectious Diseases||Other: No Intervention|
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 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 intended study sample is 500-1000 participants, with at least 200 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.
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||LoewenKIDS - Infections and the Development of the Immune System|
|Study Start Date :||February 2015|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2022|
- Other: No Intervention
- Development of immune system [ Time Frame: 6 years ]Assessment of interactions between infections, microbial colonization, vaccinations and immune response in the framework of life-course epidemiology
- Allergic dermatitis (yes/no) [ Time Frame: at age of two years ]Mechanisms of microbial challenge underlying the development of atopic dermatitis in the framework of life-course epidemiology
- Asthma [ Time Frame: at age of six years ]Mechanisms of microbial challenge underlying the development of asthma in the framework of life-course epidemiology
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02654210
|Contact: Rafael Mikolajczyk, Prof. MDfirstname.lastname@example.org|
|Contact: Cornelia Gottschick, Dr.||email@example.com|
|Helmholtz Centre for Infection Research||Recruiting|
|Braunschweig, Lower Saxony, Germany, 38124|
|Contact: Rafael Mikolajczyk, Prof. MD 0049-345-5573570 firstname.lastname@example.org|
|Contact: Heike Raupach-Rosin, MD 0049-531-61813122 email@example.com|
|Halle (Saale), Saxony-Anhalt, Germany, 06112|
|Contact: Rafael Mikolajczyk, Prof. Dr. 0049-345-5573570 firstname.lastname@example.org|
|Principal Investigator:||Rafael Mikolajczyk, Prof. Dr.||Martin-Luther-University Halle-Wittenberg; Institute of Medical Epidemiology, Biometry and Informatics|