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)

• Conditions: K50; K51; K52; U07.1; Ulcerative colitis; Crohn disease [regional enteritis]; Other noninfective gastroenteritis and colitis; COVID-19, virus identified

• Registration Number: DRKS00022155
• Lead Sponsor: Klinikum der Universität München, Campus Großhadern

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-24
• Results First Posted: 2021-09-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 556

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

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes include:<br>a) to record of previous diagnosis and symptoms of the COVID-19 infection.<br>b) to investigate the seroprevalence of SARS-CoV-2 antibodies in IBD patients compared to KoCo19<br>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.<br>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.<br>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.<br>