NCT02654210

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
782

participants targeted

Target at P75+ for all trials

Timeline
82mo left

Started Mar 2015

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Mar 2015Feb 2033

Study Start

First participant enrolled

March 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2016

Completed
17.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2033

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2033

Last Updated

October 2, 2024

Status Verified

October 1, 2024

Enrollment Period

17.9 years

First QC Date

January 11, 2016

Last Update Submit

October 1, 2024

Conditions

Infectious Diseases

Keywords

birth cohortinfectious diseasesmicrobiomeimmune systemimmune response

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Allergic dermatitis (yes/no)

    at age of two years

  • Asthma

    at age of six years

Interventions

No InterventionOTHER

No Intervention

Eligibility Criteria

Age1 Day - 3 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • newborn in a study region

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Helmholtz Centre for Infection Research

Braunschweig, Lower Saxony, 38124, Germany

Location

Martin-Luther-University Halle-Wittenberg

Halle, Saxony-Anhalt, 06112, Germany

Location

Related Publications (4)

  • 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.

    PMID: 26493700BACKGROUND

  • 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.

    PMID: 30815674BACKGROUND

  • 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.

    PMID: 35056559BACKGROUND

  • 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.

    PMID: 41114888DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Nasal swabs nasal: Microbiome Nasal swabs: Virus detection Stool sample: Microbiome Stool sample. Pathogen Detection Blood sample Buccal swab

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rafael Mikolajczyk, Prof. Dr.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2016

First Posted

January 13, 2016

Study Start

March 1, 2015

Primary Completion (Estimated)

February 1, 2033

Study Completion (Estimated)

February 1, 2033

Last Updated

October 2, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)