LoewenKIDS - Infections and the Development of the Immune System

Infectious Diseases Clinical Trial

— LoewenKIDS  

Official title:

LoewenKIDS - Infections and the Development of the Immune System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02654210
• Other study ID #: HelmholtzCIfectionsRes
• Status: Active, not recruiting
• Start date: March 2015
• Est. completion date: February 2033

Study information

• Verified date: September 2023
• Source: Helmholtz Centre for Infection Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 782
• Est. completion date: February 2033
• Est. primary completion date: February 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 3 Months

Eligibility

Inclusion Criteria:

• newborn in a study region

Exclusion Criteria:

• parents < 18 years old

• insufficient knowledge of the German language (parents)

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Infectious Diseases

Intervention

Other:
• No Intervention
No Intervention

Locations

Country	Name	City	State
Germany	Helmholtz Centre for Infection Research	Braunschweig	Lower Saxony
Germany	Martin-Luther-University Halle-Wittenberg	Halle (Saale)	Saxony-Anhalt

Sponsors (4)

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

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Asthma	Mechanisms of microbial challenge underlying the development of asthma in the framework of life-course epidemiology	at age of six years

External Links

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