Crohn's Disease and Ulcerative Colitis
Conditions
Interventions
Group 1: 25 participants with preliminary diagnosis of active Crohn's Disease will provide data via a single study-specific questionnaire within 4 weeks of a (ileo)colonoscopy. Blood, buccal, saliva a
Sponsors
Evonik Operations GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - informed consent - having undergone a previously scheduled standard of care (ileo)colonoscopy with tissue biopsy within 2 weeks of enrolment - agreeing to allow provision of biopsy samples generated prior to the study and and relevant contextual data - agreeing to and capable of study-specific sampling of buccal swab and saliva and undergoing a blood draw - agreeing to provide study-specific lifestyle and further data - agreeing to provide study-specific stool sample (optional) - having access to a smartphone/tablet or a computer with an internet access, and familiar with the use thereof (optional) - Crohn's Disease arm only, active Crohn's disease (preliminary diagnosis), untreated - Ulcerative Colitis arm only, active ulcerative colitis (preliminary diagnosis), untreated - Other disease arm only, active disease (can be preliminary) diagnosis of diverticulitis, microscopic colitis, diverticular colitis, rheumatoid arthritis, other
Exclusion criteria
Exclusion criteria: - (suspected) malignancy or history of malignancy in the past 5 years prior to study - previous colectomy - known infection with C. difficile or other intestinal pathogen - known HIV infection - moderate or severe mucosal dysplasia / adenoma in colon - prior (in the past 6 months prior to study) or current treatment with: systemic corticosteroids, 5-aminosalicylic acid, azathioprine, 6-mercaptopurine, methotrexate, biologics or immunomodulators/immunosuppressants - prior (in the past 6 months prior to study) or current treatment with antipsychotic medication or chemotherapy agents - antibiotic treatment in the past 4 weeks prior to study - pregnancy - chronic abuse of drugs or alcohol - use of parenteral feeding - participation in a study with a non-marketed investigational product during the last 6 months prior to study - any other reason for exclusion as per investigator's judgment (e.g. a condition that may potentially confound the study assessments) - Crohn's Disease and Ulcerative Colitis arms only, any other autoimmune or inflammatory disease (extraintestinal manifestations such as e.g. uveitis, primary cholangitis, erythema nodosum etc. are allowed) - Healthy arm only, any autoimmune or inflammatory disease, acute infection, virus or other illness affecting the immune/inflammatory system, any anti-inflammatory treatment - Other disease arm only, any other autoimmune or inflammatory disease beyond the one that is the basis for the inclusion in the other disease arm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| After an (ileo)colonoscopy for a preliminary diagnosis intestinal tissue, buccal swabs, saliva and blood will be collected and analysed for DNA methylation via microarray and/or sequencing. | — |
Secondary
| Measure | Time frame |
|---|---|
| After an (ileo)colonoscopy for a preliminary diagnosis feces will be optionally collected and analysed for DNA methylation via microarray or sequencing. | — |
Countries
Germany
Contacts
Public ContactUte Pohl
analyze & realize GmbH
Outcome results
None listed