Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT02654210

LoewenKIDS - Infections and the Development of the Immune System

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

1 day–3 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Helmholtz Centre for Infection Research, Braunschweig, Lower Saxony, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • newborn in a study region

Exclusion criteria

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

Treatment and study plan

No intervention

Other

No Intervention

Primary outcomes

  1. Development of immune system

    Time frame: 15 years

    Assessment of interactions between infections, microbial colonization, vaccinations and immune response in the framework of life-course epidemiology

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Helmholtz Centre for Infection Research

Other

Collaborators

  • Hannover Medical School
  • Ludwig-Maximilians - University of Munich
  • Martin-Luther-Universität Halle-Wittenberg

Registry information

Acronym: LoewenKIDS

Important dates

Study start
2015
Primary completion
2033
Study completion
2033
First posted
Jan 13, 2016
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.