Infectious DiseasesLoewenKIDSNCT02654210
LoewenKIDS - Infections and the Development of the Immune System
An observational study of Infectious Diseases, run by Helmholtz Centre for Infection Research at 2 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 1 day to 3 months
- Conditions the study is for
- Infectious Diseases
- How many people
- 782 participants
- Where
- 2 sitesGermany
- Study dates
- Mar 2015to Feb 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 3 months
- All sexes
- No healthy volunteers
- Child
Study population: Healthy Newborns in the Studyregions: Braunschweig, Hannover, Bremen, München, Halle (Saale), Germany
Who may be able to join
- newborn in a study region
Who cannot join
- parents < 18 years old
- insufficient knowledge of the German language (parents)
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Helmholtz Centre for Infection Research
Braunschweig, Lower Saxony, 38124
Martin-Luther-University Halle-Wittenberg
Halle, Saxony-Anhalt, 06112
About this study
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.
Read the 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
- Being tested
- No Intervention
- Keywords
- birth cohort, infectious diseases, microbiome, immune system, immune response
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No Intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of immune system
Assessment of interactions between infections, microbial colonization, vaccinations and immune response in the framework of life-course epidemiology
Measured: 15 years
Secondary outcomes (2)
Allergic dermatitis (yes/no)
Mechanisms of microbial challenge underlying the development of atopic dermatitis in the framework of life-course epidemiology
Measured: at age of two years
Asthma
Mechanisms of microbial challenge underlying the development of asthma in the framework of life-course epidemiology
Measured: at age of six years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startMar 2015
- Primary completionFeb 2033 (estimated)
- Study completionFeb 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Infectious DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 782 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helmholtz Centre for Infection Research
- Sponsor type
- University, hospital or other
- Collaborators
- Martin-Luther-Universität Halle-Wittenberg, Hannover Medical School, Ludwig-Maximilians - University of Munich
- Responsible party
- Sponsor
- Investigators
- Rafael Mikolajczyk, Prof. Dr., Principal investigator, Martin-Luther-University Halle-Wittenberg; Institute of Medical Epidemiology, Biometry and Informatics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654210
- Sponsor's protocol ID
- HelmholtzCIfectionsRes
- Acronym
- LoewenKIDS
- Status last verified
- Sep 2026
- First submitted
- 11 Jan 2016
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 26493700Gottschick 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.
PubMed 30815674Langer 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.
PubMed 35056559Lincetto 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.
PubMed 41114888
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LoewenKIDS - Infections and the Development of the Immune System
- ClinicalTrials.gov ID
- NCT02654210
- Acronym / sponsor ID
- LoewenKIDS / HelmholtzCIfectionsRes
- Conditions
- Infectious Diseases
- Keywords
- birth cohort, infectious diseases, microbiome, immune system, immune response
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 782 participants (actual)
- Lead sponsor
- Helmholtz Centre for Infection ResearchUniversity, hospital or other
- Collaborators
- Martin-Luther-Universität Halle-Wittenberg, Hannover Medical School, Ludwig-Maximilians - University of Munich
- Study start
- Mar 2015 (actual)
- Primary completion
- Feb 2033 (estimated)
- Study completion
- Feb 2033 (estimated)
- First posted
- 13 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Healthy Newborns in the Studyregions: Braunschweig, Hannover, Bremen, München, Halle (Saale), Germany
Key inclusion criteria (1 listed)
- newborn in a study region
Key exclusion criteria (2 listed)
- parents < 18 years old
- insufficient knowledge of the German language (parents)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionNo Intervention | Other | – |
Primary outcome
Development of immune system
Time frame: 15 years
Assessment of interactions between infections, microbial colonization, vaccinations and immune response in the framework of life-course epidemiology
2 secondary outcomes
Allergic dermatitis (yes/no)
Time frame: at age of two years
Asthma
Time frame: at age of six years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Background: PubMed 26493700Zoch 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.
- Background: PubMed 30815674Gottschick 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.
- Background: PubMed 35056559Langer 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.
- Derived from this study: PubMed 41114888Lincetto 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.
- Study website \[click here to get more information (German only)\]Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Infectious Diseases
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafael Mikolajczyk, Prof. Dr. principal investigator
Martin-Luther-University Halle-Wittenberg; Institute of Medical Epidemiology, Biometry and Informatics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infectious Diseases, run by Helmholtz Centre for Infection Research at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of immune system (time frame: 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02654210, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.