DRKS00033067招募中不适用
Epigenetic Profiling in Inflammatory Bowel Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •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
- •- 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
排除标准
- •- (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
研究者
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