LoewenKIDS - Infections and the Development of the Immune System

Active, not recruiting

• Conditions: Infectious Diseases

• Registration Number: NCT02654210
• Lead Sponsor: 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.

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 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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2016-01-11
• Study First Submitted QC: 2016-01-12
• Study First Posted: 2016-01-13
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-02
• Primary Completion: 2033-02
• Study Completion: 2033-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 782

Inclusion Criteria

• newborn in a study region

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of immune system	15 years	Assessment of interactions between infections, microbial colonization, vaccinations and immune response in the framework of life-course epidemiology

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Martin-Luther-University Halle-Wittenberg; 🇩🇪 Halle (Saale), Saxony-Anhalt, Germany

Helmholtz Centre for Infection Research; 🇩🇪 Braunschweig, Lower Saxony, Germany