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Clinical care situation, health problems and psychosocial burden during the COVID-19-pandemic in patients with chronic inflammatory bowel disease (IBD) - Part 1: Baseline survey and seroprevalence of SARS-CoV-2 antibodies compared to Munich population cohort (KoCo19)

Clinical care situation, health problems and psychosocial burden during the COVID-19-pandemic in patients with chronic inflammatory bowel disease (IBD) - Part 1: Baseline survey and seroprevalence of SARS-CoV-2 antibodies compared to Munich population cohort (KoCo19) - KoCo19-CED-1

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00022155
Enrollment
400
Registered
2020-08-24
Start date
2020-07-04
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K50 K51 K52 U07.1

Interventions

Group 1: All IBD patients who are registered in the outpatient clinic of the University Hospital of Munich have received from 04.07.2020 to 11.07.2020 a postal invitation to participate in the study w

Sponsors

Klinikum der Universität München, Campus Großhadern
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Months to No maximum

Inclusion criteria

Inclusion criteria: (a) Patients (male, female) with diagnosed IBD (Crohn's disease, ulcerative colitis, unclassified IBD) with or without comorbidity, with or without therapy at the time of inclusion (b) Age >12 months (c) Patients and parents (care givers) have adequate knowledge of German language (d) Consent to participate in the study if the person of legal age or guardian has given written and oral consent by the study staff (e) have been visiting the outpatient clinic for chronic inflammatory bowel diseases at the University Hospital of Munich (LMU Klinikum) within the last 2 years

Exclusion criteria

Exclusion criteria: (a) Inclusion criteria not met (b) Patients with monogenetic immunodeficiency disease confirmed as a cause of IBD

Design outcomes

Primary

MeasureTime frame
The study aims to establish a cohort of >400 IBD patients of all age groups for further studies of SARS-CoV-2 infections at the LMU hospital (KoCo19-CED) parallel to the Munich KoCo19-cohort (representative sample of the general population in Munich) with a phenotype of the underlying disease and a survey of treatments and comorbidities.

Secondary

MeasureTime frame
Secondary outcomes include: a) to record of previous diagnosis and symptoms of the COVID-19 infection. b) to investigate the seroprevalence of SARS-CoV-2 antibodies in IBD patients compared to KoCo19 c) to record self-reported vaccination status (varicella zoster virus, measles, mumps and rubella, pneumococcus, influenza), immune response (varicella zoster virus, measles virus) if applicable. d) to assess the impact of the pandemic to date on medication, use of outpatient and inpatient health services and the course of the IBD. e) to observe the impact of the pandemic on mental health, disease-related quality of life and social contacts at work and in private life, as well as on attendance at nursery, kindergarten, school and at work compared to the KoCo-19 cohort.

Countries

Germany

Contacts

Public ContactSimone;Thu Giang Breiteneicher;Le Thi

LMU Klinikum, Medizinische Klinik und Poliklinik II, CED-Ambulanz;Dr. von Haunersches Kinderspital Abt. Pädiatrische Gastroenterologie & Hepatologie Klinikum der Universitaet Muenchen (AöR)

kococedmed2@med.uni-muenchen.de;kococedkk@med.uni-muenchen.de089440076014;+4989440057854

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026