Epigenetic Profiling in Inflammatory Bowel Disease Patients
- Conditions
- Crohn's Disease and Ulcerative Colitis
- Registration Number
- DRKS00033067
- Lead Sponsor
- Evonik Operations GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
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
- (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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method