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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
Sponsor:
Collaborator:
Hannover Medical School
Information provided by (Responsible Party):
Helmholtz Centre for Infection Research

Brief Summary:
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.

Condition or disease Intervention/treatment
Infectious Diseases Other: No Intervention

Detailed Description:

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
Observational Model: Cohort
Time Perspective: Prospective
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

Intervention Details:
  • Other: No Intervention
    No Intervention


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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
Nasal swabs nasal: Microbiome Nasal swabs: Virus detection Stool sample: Microbiome Stool sample. Pathogen Detection Blood sample


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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Healthy Newborns in the Studyregions: Braunschweig, Hannover, Bremen, München, Halle (Saale), Germany
Criteria

Inclusion Criteria:

  • newborn in a study region

Exclusion Criteria:

  • parents < 18 years old
  • insufficient knowledge of the German language (parents)

Information from the National Library of Medicine

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


Contacts
Contact: Rafael Mikolajczyk, Prof. MD 0049-345-5573570 rafael.mikolajczyk@uk-halle.de
Contact: Cornelia Gottschick, Dr. 0049-345-5571937 cornelia.gottschick@uk-halle.de

Locations
Germany
Helmholtz Centre for Infection Research Recruiting
Braunschweig, Lower Saxony, Germany, 38124
Contact: Rafael Mikolajczyk, Prof. MD    0049-345-5573570    rafael.mikolajczyk@uk-halle.de   
Contact: Heike Raupach-Rosin, MD    0049-531-61813122    heike.rosin@helmholtz-hzi.de   
Martin-Luther-University Halle-Wittenberg Recruiting
Halle (Saale), Saxony-Anhalt, Germany, 06112
Contact: Rafael Mikolajczyk, Prof. Dr.    0049-345-5573570    rafael.mikolajczyk@uk-halle.de   
Sponsors and Collaborators
Helmholtz Centre for Infection Research
Hannover Medical School
Investigators
Principal Investigator: Rafael Mikolajczyk, Prof. Dr. Martin-Luther-University Halle-Wittenberg; Institute of Medical Epidemiology, Biometry and Informatics

Additional Information:
Publications:
Responsible Party: Helmholtz Centre for Infection Research
ClinicalTrials.gov Identifier: NCT02654210     History of Changes
Other Study ID Numbers: HelmholtzCIfectionsRes
First Posted: January 13, 2016    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Helmholtz Centre for Infection Research:
birth cohort
infectious diseases
microbiome
immune system
immune response

Additional relevant MeSH terms:
Communicable Diseases
Infection