LoewenKIDS - Infections and the Development of the Immune System (LoewenKIDS)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Infectious Diseases
• Intervention / Treatment: 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 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 Type: Observational
• Enrollment (Actual): 782

Contacts and Locations

Study Locations

• Germany
  • Lower Saxony
    • Braunschweig, Lower Saxony, Germany, 38124
      • Helmholtz Centre for Infection Research
  • Saxony-Anhalt
    • Halle (Saale), Saxony-Anhalt, Germany, 06112
      • Martin-Luther-University Halle-Wittenberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 3 months (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Healthy Newborns in the Studyregions: Braunschweig, Hannover, Bremen, München, Halle (Saale), Germany

Description

Inclusion Criteria:

• newborn in a study region

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Helmholtz Centre for Infection Research
• Collaborators: Hannover Medical School; Ludwig-Maximilians - University of Munich; Martin-Luther-Universität Halle-Wittenberg
• Investigators: Principal Investigator: Rafael Mikolajczyk, Prof. Dr., Martin-Luther-University Halle-Wittenberg; Institute of Medical Epidemiology, Biometry and Informatics

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Int J Epidemiol. 2019 Aug 1;48(4):1382-1383.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Estimated): February 1, 2033
• Study Completion (Estimated): February 1, 2033

Study Registration Dates

• First Submitted: January 11, 2016
• First Submitted That Met QC Criteria: January 12, 2016
• First Posted (Estimated): January 13, 2016

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 29, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: immune system; microbiome; birth cohort; immune response; infectious diseases
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: HelmholtzCIfectionsRes

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO