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| Name | Class |
|---|---|
| Martin-Luther-Universität Halle-Wittenberg | OTHER |
| Hannover Medical School | OTHER |
| Ludwig-Maximilians - University of Munich | OTHER |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | No Intervention |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy Newborns in the Studyregions: Braunschweig, Hannover, Bremen, München, Halle (Saale), Germany
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| Name | Affiliation | Role |
|---|---|---|
| Rafael Mikolajczyk, Prof. Dr. | Martin-Luther-University Halle-Wittenberg; Institute of Medical Epidemiology, Biometry and Informatics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helmholtz Centre for Infection Research | Braunschweig | Lower Saxony | 38124 | Germany | ||
| Martin-Luther-University Halle-Wittenberg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26493700 | Background | 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. | |
| 30815674 | Background | 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. |
| Label | URL |
|---|---|
| Study website \[click here to get more information (German only)\] | View source |
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Nasal swabs nasal: Microbiome Nasal swabs: Virus detection Stool sample: Microbiome Stool sample. Pathogen Detection Blood sample Buccal swab
| at age of six years |
| Halle |
| Saxony-Anhalt |
| 06112 |
| Germany |
| 35056559 | Background | 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. |
| 41114888 | Derived | 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. 2026 Feb;54(1):353-364. doi: 10.1007/s15010-025-02670-1. Epub 2025 Oct 20. |