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LoewenKIDS - Infections and the Development of the Immune System

LoewenKIDS - Infections and the Development of the Immune System

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02654210
Acronym
LoewenKIDS
Enrollment
782
Registered
2016-01-13
Start date
2015-03-31
Completion date
2033-02-28
Last updated
2024-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infectious Diseases

Keywords

birth cohort, infectious diseases, microbiome, immune system, immune response

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.

Interventions

OTHERNo Intervention

No Intervention

Sponsors

Martin-Luther-Universität Halle-Wittenberg
CollaboratorOTHER
Hannover Medical School
CollaboratorOTHER
Ludwig-Maximilians - University of Munich
CollaboratorOTHER
Helmholtz Centre for Infection Research
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 3 Months
Healthy volunteers
No

Inclusion criteria

* newborn in a study region

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Development of immune system15 yearsAssessment of interactions between infections, microbial colonization, vaccinations and immune response in the framework of life-course epidemiology

Secondary

MeasureTime frameDescription
Allergic dermatitis (yes/no)at age of two yearsMechanisms of microbial challenge underlying the development of atopic dermatitis in the framework of life-course epidemiology
Asthmaat age of six yearsMechanisms of microbial challenge underlying the development of asthma in the framework of life-course epidemiology

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026