LoewenKIDS - Infections and the Development of the Immune System

NCT ID: NCT02654210

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 782 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2033-02-28

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.

Conditions

Infectious Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

No Intervention

No Intervention

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• newborn in a study region

Exclusion Criteria

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Martin-Luther-Universität Halle-Wittenberg

OTHER

Sponsor Role: collaborator

Hannover Medical School

OTHER

Sponsor Role: collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role: collaborator

Helmholtz Centre for Infection Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rafael Mikolajczyk, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Martin-Luther-University Halle-Wittenberg; Institute of Medical Epidemiology, Biometry and Informatics

Locations

Helmholtz Centre for Infection Research

Braunschweig, Lower Saxony, Germany

Martin-Luther-University Halle-Wittenberg

Halle, Saxony-Anhalt, Germany

Countries

Germany

References

Zoch B, Karch A, Dreesman J, Monazahian M, Baillot A, Mikolajczyk RT. Feasibility of a birth cohort study dedicated to assessing acute infections using symptom diaries and parental collection of biomaterials. BMC Infect Dis. 2015 Oct 22;15:436. doi: 10.1186/s12879-015-1189-0.

Reference Type: BACKGROUND

PMID: 26493700 (View on PubMed)

Gottschick C, Raupach-Rosin H, Langer S, Hassan L, Horn J, Dorendorf E, Caputo M, Bittner M, Beier L, Rubsamen N, Schlinkmann K, Zoch B, Guzman CA, Hansen G, Heselich V, Holzapfel E, Hubner J, Pietschmann T, Pieper DH, Pletz M, Riese P, Schmidt-Pokrzywniak A, Hartwig S, von Kaisenberg C, Aydogdu M, Buhles M, Dressler F, Eberl W, Haase R, Edler von Koch F, Feidicker S, Frambach T, Franz HGB, Guthmann F, Koch HG, Seeger S, Oberhoff C, Pauker W, Petry KU, Schild RL, Tchirikov M, Rohrig E, Karch A, Mikolajczyk R. Cohort Profile: The LoewenKIDS Study - life-course perspective on infections, the microbiome and the development of the immune system in early childhood. Int J Epidemiol. 2019 Aug 1;48(4):1042-1043h. doi: 10.1093/ije/dyz001. No abstract available.

Reference Type: BACKGROUND

PMID: 30815674 (View on PubMed)

Langer S, Horn J, Gottschick C, Klee B, Purschke O, Caputo M, Dorendorf E, Meyer-Schlinkmann KM, Raupach-Rosin H, Karch A, Rubsamen N, Aydogdu M, Buhles M, Dressler F, Eberl W, Koch FEV, Frambach T, Franz H, Guthmann F, Guzman CA, Haase R, Hansen G, Heselich V, Hubner J, Koch HG, Oberhoff C, Riese P, Schild R, Seeger S, Tchirikov M, Trittel S, von Kaisenberg C, Mikolajczyk R. Symptom Burden and Factors Associated with Acute Respiratory Infections in the First Two Years of Life-Results from the LoewenKIDS Cohort. Microorganisms. 2022 Jan 5;10(1):111. doi: 10.3390/microorganisms10010111.

Reference Type: BACKGROUND

PMID: 35056559 (View on PubMed)

Lincetto C, Romero-Saavedra F, Laverde D, Lincetto R, Meyer-Buehn M, Klee B, Gottschick C, Mikolajczyk R, Huebner J, Schober T. Detection of enteric pathogens in young children before and during acute gastroenteritis: results from a prospective German birth cohort study (LoewenKIDS). Infection. 2025 Oct 20. doi: 10.1007/s15010-025-02670-1. Online ahead of print.

Reference Type: DERIVED

PMID: 41114888 (View on PubMed)

Related Links

http://www.loewenkids-study.de

Study website \[click here to get more information (German only)\]

Other Identifiers

HelmholtzCIfectionsRes

Identifier Type: -

Identifier Source: org_study_id